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BRC6F (SWOG S1400F)A Phase II Study of MEDI4736 (Durvalumab) Plus Tremelimumab as Therapy for Patients with Previously Treated Anti-PD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-MAP Non-Match Sub-Study)
A Phase II Study of MEDI4736 (Durvalumab) Plus Tremelimumab as Therapy for Patients with Previously Treated Anti-PD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-MAP Non-Match Sub-Study)

Complexity Level: 2

Eligibility: Patients must:(1)be assigned to BRC6F (2)have progressed during/after prior platinum-based chemo, or after anti-PD-1/anti-PD-L1 Ab monotherapy (3)no prior exposure to CTLA-4 inhibitors (ipilimumab & tremelimumab) (4)not received nitrosoureas or mitomycin-c within 42 d (5)no prior autoimmune/inflammatory disease within 3 y (6)no history of primary immunodeficiency (7)no immunosuppressive meds within 28 d. Systemic corticosteroids stopped at least 24 h (8) no Gr 3 or worse irAE (9)no organ transplant that requires immunosuppressives (10)no allergy/reaction to Durvalumab &/or tremelimumab (11)no active tuberculosis infection (12)no live attenuated vaccination within 28 d (13)no known HIV, or + test for Hep B virus surface antigen (HBV sAg), or Hep C virus ribonucleic acid (HCV Ab) indicating current acute/chronic infection (14)have TSH with reflex T3/T4 free (if TSH is out of normal range) & ECG within 7 d (15)specimen banking (16)see also common eligibility criteria of main BRC6 trial.

Objectives: (1) to evaluate ORR (confirmed & unconfirmed, CR & PR) by RECIST 1.1 among patients treated with Durvalumab + Tremelimumab (2) to estimate DoR among patients who achieve a CR or PR (confirmed and unconfirmed) by RECIST 1.1 (3) to estimate the DoR per immune-related response criteria for patients who achieve a CR or PR (confirmed & unconfirmed) by RECIST 1.1 (4) to evaluate OS for patients treated with Durvalumab + Tremelimumab (5) to evaluate IA-PFS for patients treated with Durvalumab + Tremelimumab (6) to evaluate IA-PFS assessed by immune-related response criteria (irRC-IA-PFS) for patients treated with Durvalumab + Tremelimumab (7) to evaluate the frequency & severity of toxicities associated with Durvalumab + Tremelimumab (8) to explore the association of potential predictive markers identified in BRC6A, with response & PFS (9) to explore the association of PD-L1 expression status with response & PFS (10) to contribute to an ongoing BRC6 serum & tumor bank.

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Planned

Planned
BR31A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer
A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer

Complexity Level: 2

Eligibility: Completely resected primary stage IB (>= 4cm), II and IIIA non-small cell lung cancer patients (with or without adjuvant platinum based chemotherapy). After 600 patients have been accrued, only patients with PD-L1 positive tumours will be enrolled.

Objectives: Primary Objective: Disease free survival (DFS) for patients with NSCLC that is PD-L1 positive. Secondary Objectives: DFS in all randomized patients, overall survival (OS) for patients with NSCLC that is PD-L1 positive, OS for all randomized patients, lung cancer specific survival for patients with NSCLC that is PD-L1 positive and all randomized patients, adverse effects and tolerability of MEDI4736, Quality of Life, survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile, economic evaluation (cost effectiveness and cost utility), evaluation of predictive/prognostic significance of PD-L1 expression, evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event, exploratory pharmacogenomic assays (baseline only).

NCT Registration ID (from clinicaltrials.gov): NCT02273375
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: October 09, 2014

Chair: (Canada) Dr. Glenwood Goss, Ottawa Hospital Research Institute, (613) 737-8899 Ext. 73955, () Dr. Yi-Long Wu, Chinese Thoracic Oncology Group


Open to Accrual
BR34A Randomized Trial of Durvalumab and Tremelimumab +/- Platinum Based Chemotherapy in Patients with High-Risk Metastatic (Stage IV) Squamous or Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
A Randomized Trial of Durvalumab and Tremelimumab +/- Platinum Based Chemotherapy in Patients with High-Risk Metastatic (Stage IV) Squamous or Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Complexity Level: 2

Eligibility: - histologically and/or cytologically confirmed squamous or non-squamous NSCLC confirmed by IHC. Known EGFR mutations or ALK fusions are NOT eligible. - high risk (defined as one or more of the following: stage IVB, or IVA with either elevated LDH, weight loss greater than or equal to 5% over past 3 months, poorly differenced histology) - must consent to tissue submission for PD-L1 testing. - measureable disease (RECIST 1.1) assessed within 28 days prior to randomization - 18 years of age or older - ECOG 0 or 1 - adequate hematology and biochemistry - no prior cytotoxic chemotherapy for advanced/metastatic disease - no prior EGFR, ALK inhibitors or immunotherapy

Objectives: Primary Objective To compare the overall survival (OS) of patients receiving durvalumab, tremelimumab plus platinum-based chemotherapy to that of patients receiving durvalumab and tremelimumab alone. Secondary Objectives - To compare progression free survival (PFS; RECIST 1.1) at 1 year between arms - To compare objective response rate (ORR; RECIST 1.1 and iRECIST) between arms - To compare Quality of life (QoL) between arms - To evaluate the nature, severity, and frequency of toxicities between arms. - To evaluate the incremental cost effectiveness and cost utility ratios between arms - To correlate the expression of tissue (including PD-L1) and blood markers with outcomes and response. Exploratory Objectives - To evaluate the correlation between aberrations detected using genomic cell-free DNA in blood and outcomes - Progression free survival as defined by iRECIST

NCT Registration ID (from clinicaltrials.gov): NCT03057106
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: February 15, 2017

Chair: (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645


Open to Accrual
BRC6 (SWOG S1400)A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer
A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer

Complexity Level: 2

Eligibility: PRE-SCREENING/SCREENING ELIGIBIILITY - patients must: (1) have pathologically proven Stage IV squamous cell lung cancer, (2) have an adequate tissue specimen as defined in the protocol and confirmed by the local pathologist, (3) not have a known EGFR mutation or ALK fusion, (4) must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment, (5) have Zubrod PS 0-1, (4) be > or = 18 years of age, (5) be offered participation in banking for future use of specimens (6) have previously received or currently be receiving a platinum-based chemotherapy regimen.

Objectives: (1) to establish a NCTN mechanism for genomically screening large but homogeneous cancer populations & subsequently assigning and accruing simultaneously to a multi-sub-study Master Protocol. Each of the biomarker-driven sub-studies in this protocol will evaluate a targeted therapy (TT) or targeted therapy combination (TTC) based on a designated therapeutic biomarker-drug combination, with the ultimate goal being approval of new targeted therapies in this setting. Non-match sub-studies will evaluate nonmatch therapies (NMT) in patients not eligible for any of the biomarker-driven sub-studies, also with the goal of approval (2) to evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study, (3) to establish a tissue/ blood repository from patients with refractory squamous cell cancer.

NCT Registration ID (from clinicaltrials.gov): NCT02154490
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: April 15, 2016

Chair: (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645


Open to Accrual
BRC6G (SWOG S1400G)A Phase II Study of Talazoparib (BMN 673) in Patients with Homologous Recombination Repair Deficiency Positive Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)
A Phase II Study of Talazoparib (BMN 673) in Patients with Homologous Recombination Repair Deficiency Positive Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)

Complexity Level: 2

Eligibility: Patients must: (1) be assigned to BRC6G (i.e., defined as HRRD positive),(2) not have prior exposure to any agent with a PARP inhibitor,(3) have achieved SD, a PR, or a CR at their first assessment after initiating first-line platinum-based chemotherapy, (4) not have any impairment of GI function or GI disease that may significantly alter absorption of talazoparib, (5) be able to take oral medications, (6) not be taking, nor plan to take while on protocol treatment strong P-gp inhibitors, P-gp inducers, or BCRP inhibitors, (7) agree to have blood specimens submitted for PK analysis, (8) see also common eligibility criteria of main BRC6 trial.

Objectives: (1) to evaluate the overall response rate (ORR) (confirmed and unconfirmed, complete and partial) with talazoparib in HRRD MDVN-positive patients, (2) to evaluate investigator- assessed PFS (IA-PFS) & OS associated with therapy in HRRD MDVN-positive patients, (3) to evaluate ORR, IA-PFS, and OS in HRRD FMI-positive patients, (4) to evaluate ORR in HRRD MDVN-negative/ HRRD FMI-positive patients, (5) to evaluate the frequency and severity of toxicities associated with talazoparib in HRRD FMI-positive patients, (6) to assess if the HRD score is associated with clinical outcomes (response, PFS, OS) in HRRD FMI-positive patients treated with talazoparib, (7) to assess if the level of PARP protein expression determined by immunohistochemistry is associated with clinical outcomes (response, PFS, OS) in HRRD FMI-positive patients treated with talazoparib, (8) to characterize pharmacokinetic properties of talazoparib.

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: September 20, 2017

Chair: (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645


Open to Accrual
BRC6I (SWOG S1400I)A Phase III Randomized Study of Nivolumab plus Ipilimumab versus Nivolumab for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (Lung-Map Sub-Study)
A Phase III Randomized Study of Nivolumab plus Ipilimumab versus Nivolumab for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (Lung-Map Sub-Study)

Complexity Level: 2

Eligibility: Patients must (1)be assigned to BRC6I, (2) not had prior treatment with an anti-PD-1, anti-PDL1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways,(3) not have an active, known, or suspected autoimmune disease,(4) not have any known allergy or reaction to any component of the nivolumab & ipilimumab formulations,(5) not have received systemic treatment with corticosteroids or other immunosuppressive medications within 14 D,(6)not have a known + test for HBV sAg or HCV antibody indicating acute or chronic infection,(7) not have known history of testing positive for HIV or known AIDS,(8) not have interstitial lung disease that is symptomatic or disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity,(9) must also be offered participation in banking for future use of specimens,(10) see also common eligibility criteria of main BRC6 trial.

Objectives: (1) to compare OS in patients with advanced stage refractory SCCA of the lung randomized to nivolumab plus ipilimumab vs nivolumab, (2) to compare investigator-assessed PFS in patients with advanced stage refractory SCCA of the lung randomized to nivolumab plus ipilimumab vs nivolumab,(3) to compare the response rates (confirmed and unconfirmed, complete and partial) per RECIST 1.1 among patients randomized to receive nivolumab plus ipilimumab vs nivolumab,(4) to compare the response rates (confirmed only, complete and partial) per RECIST 1.1 among patients randomized to receive nivolumab plus ipilimumab vs nivolumab, (5) to evaluate the frequency and severity of toxicities associated with nivolumab plus ipilimumab vs nivolumab, (6) to evaluate if there is an differential treatment effect on OS, IA-PFS, and Response by tumor PD-L1 expression status.

NCT Registration ID (from clinicaltrials.gov): NCT02154490
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: April 15, 2016

Chair: (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645


Open to Accrual
I227A Phase II Randomized Study of Pembrolizumab in Patients with Advanced Malignant Pleural Mesothelioma
A Phase II Randomized Study of Pembrolizumab in Patients with Advanced Malignant Pleural Mesothelioma

Complexity Level: 1

Eligibility: Patients must have histologically confirmed unresectable advanced and/or metastatic malignant pleural mesothelioma with available tumour block. No prior chemotherapy for advanced/metastatic disease. Prior (neo) adjuvant cisplatin-based systemic chemotherapy allowed if last dose > 12 months before registration. No prior targeted small molecule therapy, immunotherapies and viral therapies, biologic therapies and angiogenesis inhibitors for advanced/metastatic disease, or any prior immunotherapy for any stage of disease. Prior radiation therapy is permitted (< 30% BM), measurable disease outside the previously irradiated area is required. No diagnosis of immunodeficiency or is receiving systemic steroid therapy (doses > 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to first dose of trial treatment. No active autoimmune disease requiring systemic treatment < 3 years. No live attenuated vaccines within 30 days.

Objectives: Primary - To evaluate whether pembrolizumab, alone or given to patients receiving standard chemotherapy, improves progression free survival in malignant pleural mesothelioma (MPM) compared to standard chemotherapy. Secondary - To evaluate the tolerability of pembrolizumab, alone or given to patients receiving standard chemotherapy; To assess antitumour activity of pembrolizumab, alone or given to patients receiving standard chemotherapy including response rate and overall survival; To evaluate quality of life effects of pembrolizumab, alone or given to patients receiving standard chemotherapy. Exploratory - To explore the predictive and prognostic value of PD-L1 expression and presence of T cell subsets within the tumour microenvironment and other exploratory blood based biomarkers.

NCT Registration ID (from clinicaltrials.gov): NCT02784171
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: October 07, 2016

Chair: (Italy) Dr. Francesco Perrone, National Cancer Institute of Naples, (81) 590-3571, (Canada) Dr. Quincy Chu, Cross Cancer Institute, (780) 432-8248


Open to Accrual
BR16 (ECOG E5597)Phase III Chemoprevention Trial of Selenium Supplementation in Persons With Resected Stage 1 Non-Small Cell Lung Cancer
Phase III Chemoprevention Trial of Selenium Supplementation in Persons With Resected Stage 1 Non-Small Cell Lung Cancer

Complexity Level: 3

Eligibility: Patients who have undergone complete resection of a histologically proven stage 1A (pT1N0) or 1B (pT2N0) non-small cell lung cancer (except carcinod) who are currently free of disease. To be pathologic stage N0, at least one mediastinal node must have been sampled at resection. Centres who are participating on NCIC CTG study BR.10 may not randomize patients with stage T2N0 until BR.10 closes to accrual.

Objectives: To evaluate the efficacy of selenium supplementation in reducing the incidence of second primary lung tumours in patients who have been treated for Stage 1 non-small cell lung cancer with complete surgical resection. To evaluate the qualitative and quantitative toxicity of selenium supplementation in a daily administration schedule. To compare the incidence of specific cancers and mortality from cancer as well as overall survival of patients treated with selenium supplementation versus patients treated with placebo.

NCT Registration ID (from clinicaltrials.gov): NCT00008385
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: November 23, 2000 Closing Date: November 05, 2009

Chair: (Canada) Dr. Michael R. Johnston, QEII Health Sciences Centre, (902) 473-2281


Closed to Accrual
BR28 (MLCG CONVERT)Concurrent ONce-daily VErsus twice-daily RadioTherapy: A 2-arm randomised controlled trial of concurrent chemo-radiotherapy comparing twice-daily and once-daily radiotherapy schedules in patients with limited stage small cell lung cancer (SCLC) and good performance status
Concurrent ONce-daily VErsus twice-daily RadioTherapy: A 2-arm randomised controlled trial of concurrent chemo-radiotherapy comparing twice-daily and once-daily radiotherapy schedules in patients with limited stage small cell lung cancer (SCLC) and good performance status

Complexity Level: 2

Eligibility: Patients with histologically or cytologically confirmed small cell lung cancer (SCLC). Performance status must be ECOG grade 0-1. Patients with PS 2 whose general condition is explained by obstructive/bulky disease likely to improve after the first cycle of chemotherapy can be included at the discretion of the local investigator.

Objectives: Overall survival Local progression-free survival; Metastasis-free survival; CTCAE v3.0 toxicity; Cytotoxic dose intensity; Radiotherapy dose intensity; Prospective cost-effectiveness analysis.

NCT Registration ID (from clinicaltrials.gov): NCT00433563
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: December 09, 2008 Closing Date: July 22, 2013

Chair: (Canada) Dr. Andrea Bezjak, University Health Network, (416) 946-2132


Closed to Accrual
BRC2 (ECOG 1505)A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (>/= 4 cm) - IIIA Non-Small Cell Lung Cancer (NSCLC)
A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (>/= 4 cm) - IIIA Non-Small Cell Lung Cancer (NSCLC)

Complexity Level: 2

Eligibility: To be eligible for the trial, all patients must have undergone complete resection of their cancer prior to enrollment. It is expected that at a minimum, mediastinal lymph node systematic sampling will have occurred, though complete mediastinal lymph node dissection (MLND) will be preferred.

Objectives: Primary Objective: To evaluate overall survival with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>/= 4 cm) - IIIA NSCLC. Secondary Objectives: To evaluate disease free survival and toxicity with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>/= 4 cm) - IIIA NSCLC. To perform analyses of tissue and blood to establish factors that predict for clinical outcome in patients receiving chemotherapy, with or without bevacizumab, for resected early stage NSCLC. To determine whether smoking status is linked to outcome for patients with resected stage IB (>/= 4 cm) - IIIA NSCLC treated with chemotherapy with or without bevacizumab in the adjuvant setting.

NCT Registration ID (from clinicaltrials.gov): NCT00324805
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: August 28, 2007 Closing Date: September 20, 2013

Chair: (Canada) Dr. Charles Butts, Cross Cancer Institute, (780) 432-8513, (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645


Closed to Accrual
BRC2E (BRC2E)A Prospective Economic Analysis of NCIC CTG BRC.2/E1505 A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (>/= 4 cm) - IIIA Non-Small Cell Lung Cancer (NSCLC)
A Prospective Economic Analysis of NCIC CTG BRC.2/E1505 A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (>/= 4 cm) - IIIA Non-Small Cell Lung Cancer (NSCLC)

Complexity Level: 3

Eligibility: All Canadian patients registered to BRC.2.

Objectives: Primary Objective: To determine the incremental cost effectiveness ratio of adding bevacizumab to cisplatin-based chemotherapy as adjuvant treatment after resection of Stage IB (>= 4 cm) to IIIA NSCLC in the BRC.2/E1505 (core protocol) randomized trial. Direct medical costs will be estimated from the perspective of the Canadian public healthcare system. Secondary Objectives: To determine the direct medical costs of adjuvant chemotherapy plus bevacizumab in the BRC.2/E1505 trial. To determine the incremental cost effectiveness of bevacizumab plus cisplatin-based adjuvant chemotherapy in preplanned patient subsets in the BRC.2/E1505 trial by, smoking status, stage (IB, II, IIIA, N2), gender, chemotherapy type, and predictive molecular factors, (VEGF, ICAM serum levels).

Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: August 28, 2007 Closing Date: September 20, 2013

Chair: (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645


Closed to Accrual
BRC5 (CALGB 140503)A Phase III Randomized Trial of Lobectomy Versus Sublobular Resection For Small, (</= to 2cm) Peripheral Non-Small Cell Lung Cancer
A Phase III Randomized Trial of Lobectomy Versus Sublobular Resection For Small, (</= to 2cm) Peripheral Non-Small Cell Lung Cancer

Complexity Level: 1

Eligibility: Non Small Cell Lung Cancer - Stage 1

Objectives: Primary Objective: To determine whether DFS after sublobar resection (segmentectomy or wedge) is non-inferior to that after lobectomy in patients with small peripheral NSCLC. Secondary Objectives: To determine whether overall survival(after sublobar resection) is non-inferior to that after lobectomy; to determine the rates of loco-regional and systemic recurrence (exclusive of second primaries) after lobar and sublobar resection; to determine the difference between the two arms of the study in pulmonary function as determined by expiratory flow rates measured at 6 months post-operatively. Imaging Substudy: To explore the relationship between characteristics of the primary lung cancer, as revealed by pre-operative CT and PET imaging, and outcomes; a determination of the false-negative rate of the pre-operative PET scan for identification of involved hilar and mediastinal lymph nodes; and an assessment of the utility of annual follow-up CT imaging after surgical resection.

NCT Registration ID (from clinicaltrials.gov): NCT00499330
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: February 07, 2008 Closing Date: April 04, 2017

Chair: (Canada) Dr. Massimo Conti, University Institute of Cardiology and, (418) 656-8711


Closed to Accrual
BRC6B (SWOG S1400B)A Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)
A Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)

Complexity Level: 2

Eligibility: Patients must:(1) be assigned to BRC6B (i.e., defined as PI3K positive after biomarker testing),(2) have a HbAic <7% and fasting glucose < 125 mg/dL,(3) not have Type I or II diabetes that requires anti-hyperglycemic medication,(4) not have active or history of small or large intestine inflammation (eg. Crohn's disease or ulcertive colitis),(5) not require daily supplemental O2,(6) be able to take oral medications. Patients may not have any impairment or gastrointestinal function or disease that may significantly alter absorption of Taselisib-eg. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection,(7) not be taking, or plan to take while on protocol treatment and for 14 days post last dose of study treatment, drugs, herbal supplements, or foods that are known to be strong/moderate CYP3A4 substrates,(8) be offered participation in banking for future use of specimens,(9) see also common eligibility criteria of main BRC6 trial.

Objectives: (1) to evaluate Taselisib (GDC-0032), a PI3K inhibitor, in PI3K-positive patients,(2) within Ph II component of BRC6B, to evaluate if there is sufficient evidence to continue to Ph III,(3) to evaluate investigator-assessed PFS & OS (4)to evaluate ORR,(5) to establish a tissue/blood repository from patients with refractory lung squamous cell carcinoma, (6) to evaluate DOR,(7) to evaluate frequency & severity of toxicities associated with Taselisib,(8) to identify additional predictive tumour/blood biomarkers that may modify response or define resistence to Taselisib,(9) to identify potential resistence biomarkers at PD.

NCT Registration ID (from clinicaltrials.gov): NCT02154490
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual Closing Date: December 13, 2016

Chair: (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645


Closed to Accrual
BRC6C (SWOG S1400C)A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)
A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)

Complexity Level: 2

Eligibility: Patients must: (1) be assigned to BRC6C (i.e., defined as Cell Cycle Gene Alteration Positive, (2) not be taking within 7 days prior to sub-study registration, nor plan to take while on protocol treatment and for 14 days after the last dose of study treatment, strong CYP3A4 inhibitors and/or strong CYP3A4 inducers, and/or drugs known to prolong the QT interval, (3) not have a screening QTcF interval > 480 msec based on the average of triplicate EKGs performed within 28 days prior to registration, (4) be able to take oral medications, (5) be offered participation in banking for future use of specimens,(6) see also common eligibility criteria of main BRC6 trial.

Objectives: (1) within Ph II component of BRC6C, to evaluate if there is sufficient evidence to continue to Ph III by evaluating ORR for cell cycle gene alteration positive patients registered to BRC6C treated with palbociclib,(2) to evaluate investigator-assessed PFS & OS cell cycle gene alteration-positive treatments with palbociclib, (3) to evaluate duration of response (DoR) among cell cycle gene alteration positive patients treated with palbociclib who achieve a CR or PR by RECIST 1.1, (4) to evaluate frequency & severity of toxicities associated with palbociclib, (5) to identify additional predictive tumour/blood biomarkers that may modify response or define resistance to palbociclib, (6) identify potential resistance biomarkers at PD, (7) establish a tissue/ blood repository from patients with refractory squamous cell carcinoma of the lung.

NCT Registration ID (from clinicaltrials.gov): NCT02154490
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual Closing Date: September 01, 2016

Chair: (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645


Closed to Accrual
BRC6D (SWOG S1400D)A Phase II Study of AZD4547 for Previously Treated FGFR-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)
A Phase II Study of AZD4547 for Previously Treated FGFR-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)

Complexity Level: 2

Eligibility: Patients must:(1)be assigned to BRC6D (i.e., defined as FGFR positive),(2)be 25 years,(3)not be taking drugs, herbal supplements or foods that are known to be strong/moderate CYP3A4-CYP2D6 substrates,(4)not have received nitrosourea or mitomycin C within 42 D prior to sub-study registration, (5) not have had any prior exposure to any agent with FGFR inhibition as its primary pharmacology,(6)not have a mean resting QTc > 450 msec obtained from 3 consecutive ECGs,(7)not be planning to receive any concomitant medication known to prolong QT interval, (8) be able to take oral medications,(9)not have a history of hypersensitivity to active or inactive excipients of AZD4547 or with a similar chemical structure or class,(10) not have any of the listed ophthalmological criteria, (11) have an eye exam,(12)have corrected Ca and Phos < ULN,(13)have MUGA/echocardiogram,(14)be offered participation in banking for future use of specimens,(15)see also common eligibility criteria of main BRC6 trial.

Objectives: (1) within Ph II component of BRC6D, to evaluate if there is sufficient evidence to continue to Ph III by evaluating ORR with AZD4547 in FGFR-positive patients,(2) to evaluate investigator-assessed PFS & OS in FGFR-positive patients treated with AZD4547, (3) to evaluate duration of response (DoR) among FGFR positive patients treated with AZD4547 who achieve a CR or PR by RECIST 1.1, (4) to evaluate frequency & severity of toxicities associated with AZD4547 in FGFR positive patients, (5) to identify additional predictive tumour/blood biomarkers that may modify response or define resistance toAZD4547 beyond the chosen biomarker for biomarker-driven sub-studies, (6) identify potential resistance biomarkers at PD, (7) establish a tissue/ blood repository from patients with refractory squamous cell carcinoma of the lung.

NCT Registration ID (from clinicaltrials.gov): NCT02154490
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual Closing Date: October 31, 2016

Chair: (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645


Closed to Accrual
I211A Randomized Phase II Study of Reolysin in Patients With Previously Treated Advanced or Metastatic, Non Small Cell Lung Cancer Receiving Standard Salvage Therapy.
A Randomized Phase II Study of Reolysin in Patients With Previously Treated Advanced or Metastatic, Non Small Cell Lung Cancer Receiving Standard Salvage Therapy.

Complexity Level: 2

Eligibility: Patients with a histological or cytological diagnosis of non small cell lung cancer, that is advanced and/or metastatic, for which systemic treatment with docetaxel or pemetrexed is indicated. Tumour block available. Patients must have measureable disease as defined by RECIST 1.1. Must have received one prior regimen of pallative first line chemotherapy (must be platinum containing combination unless patient >70 years), which may not have contained docetaxel. Patients who have had concurrent platinum based chemoradiotherapy for stage 3 disease and have relapsed within 1 year of treatment may be considered to have had one prior platinum containing regimen. Prior pemetrexed first line but not maintenance therapy is permissible and prior adjuvant chemotherapy is permitted if completed at least one year prior to relapse/recurrance. ECOG 0 or 1. No neuropathy >=2.

Objectives: Primary Objective: To evaluate the effect of reolysin in combination with either docetaxel or pemetrexed on the progression free survival of patients with advanced or metastatic non small cell lung cancer. Secondary Objectives: a) To determine the tolerability and toxicity of reolysin and docetaxel or pemetrexed when given in combination. b) To investigate additional potential measures of efficacy including: progression at 3 months, objective response rate and overall survival. c) To explore potential molecular factors predictive of response by assessment of archival tumour tissue and serial blood samples, including KRAS and EGFR status.

NCT Registration ID (from clinicaltrials.gov): NCT01708993
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: October 15, 2012 Closing Date: August 06, 2015

Chair: (Canada) Dr. Donald G. Morris, Tom Baker Cancer Centre, (403) 521-3347


Closed to Accrual
I215A Phase Ib Study of Selumetinib in Patients with Previously Treated or Untreated Advanced/Metastatic NSCLC Who are Receiving Standard Chemotherapy Regimens.
A Phase Ib Study of Selumetinib in Patients with Previously Treated or Untreated Advanced/Metastatic NSCLC Who are Receiving Standard Chemotherapy Regimens.

Complexity Level: 1

Eligibility: Patients with histologic and/or cytologic confirmed non-small cell lung cancer that is metastatic or unresectable and for which standard curative measures do not exist. Patients accrued to the pemetrexed single agent cohort as well as those accrued to the RP2D expansion cohorts must have documented KRAS mutation, as well as at least one site of disease which is unidimensionally measurable. Patient must have a formalin fixed paraffin embedded tissue block (from their primary or metastatic tumour). At least 14 days since major surgery, 4 weeks since radiation therapy. ECOG 0-1. Age > 18 years. No prior MEK inhibitors or any other tyrosine kinase inhibitor.

Objectives: Primary Objective: To determine the recommended phase II dose (RP2D) and safety profile of selumetinib in patients with advanced/metastatic NSCLC in combination with: pemetrexed; pemetrexed and cisplatin; paclitaxel and carboplatin. Secondary Objectives: 1) to obtain pharmacokinetic (PK) profiles of selumetinib when given daily continuously in combination with chemotherapy; 2) to explore gene expression signatures/profiles and/or KRAS codon subtypes in tumour and/or tumour derived material that may influence response; the use of plasma as a potential source of circulating free tumour DNA (cfDNA) for the analysis of KRAS mutation status; and serum exploratory markers that may predict response to selumetinib; 3) preliminary assessment of efficacy in all patients and in an expansion cohort of up to 10 patients with KRAS positive NSCLC.

NCT Registration ID (from clinicaltrials.gov): NCT01783197
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: January 30, 2013 Closing Date: October 16, 2015

Chair: (Canada) Dr. Garth Nicholas, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70178, (Canada) Dr. John Goffin, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495


Closed to Accrual
I219A Randomized Phase II Trial of Selumetinib in Patients Receiving Standard Pemetrexed and Platinum-Based Chemotherapy for the Treatment of Advanced or Metastatic KRAS Wildtype or Unknown Non-Squamous Non-Small Cell Lung Cancer
A Randomized Phase II Trial of Selumetinib in Patients Receiving Standard Pemetrexed and Platinum-Based Chemotherapy for the Treatment of Advanced or Metastatic KRAS Wildtype or Unknown Non-Squamous Non-Small Cell Lung Cancer

Complexity Level: 2

Eligibility: Patients with histologically and/or cytologically confirmed stage IIIB/IV non-squamous, KRAS wildtype or unknown, NSCLC that is metastatic or unresectable and for which standard curative measures do not exist. All patients must have formalin fixed paraffin embedded tissue block available for correlative studies. Must have at least one site of disease that is unidimensionally measurable. ECOG 0-1. No prior MEK inhibitors or tyrosine kinase inhibitor (including EGFR inhibitors of any kind). Prior adjuvant platinum-based chemotherapy or combined chemoradiation with curative intent is permissible if completed > 1 yr prior to enrolment. No prior cytotoxic chemotherapy for advanced/metastatic disease. No significant cardiac disease or gastrointestinal disease. No untreated brain or meningeal metastases (untreated or treated). No potent inhibitors/inducers of CYP3A4/5,CYP2C19/CYP1A2. No central serous retinopathy, retinal vein occlusion, high intraocular pressure or uncontrolled glaucoma.

Objectives: Primary Objective: To determine the efficacy, as determined by objective response rate, of selumetinib (intermittent or continuous) in patients with NSCLC not known to have KRAS mutation receiving standard pemetrexed and cisplatin chemotherapy compared to chemotherapy alone. Secondary Objectives: To assess the tolerability of selumetinib in patients receiving pemetrexed and cisplatin, to explore the progression free survival of patients receiving selumetinib with pemetrexed and cisplatin to those receiving pemetrexed and cisplatin or carboplatin alone and to explore whether KRAS mutation, other common mutations, or tumour based molecular signatures are predictive of selumetinib effect.

NCT Registration ID (from clinicaltrials.gov): NCT02337530
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: February 05, 2015 Closing Date: May 08, 2017

Chair: (Canada) Dr. Barbara Lynn Melosky, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2017, (Canada) Dr. Penelope A. Bradbury, University Health Network, (416) 946-4501 Ext. 3544


Closed to Accrual
BR10A Phase III Prospective Randomized Study of Adjuvant Chemotherapy with Vinorelbine and Cisplatin in Completely Resected Non-Small Cell Lung Cancer with Companion Tumour Marker Evaluation
A Phase III Prospective Randomized Study of Adjuvant Chemotherapy with Vinorelbine and Cisplatin in Completely Resected Non-Small Cell Lung Cancer with Companion Tumour Marker Evaluation

NCT Registration ID (from clinicaltrials.gov): NCT00002583
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 07, 1994 Closing Date: April 30, 2001

Permanently Closed
BR11 (9416)Induction Chemoradiotherapy Followed by Surgical Resection for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumours): A Phase II Trial
Induction Chemoradiotherapy Followed by Surgical Resection for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumours): A Phase II Trial

NCT Registration ID (from clinicaltrials.gov): NCT00002642
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: July 10, 1995 Closing Date: August 01, 1999

Chair: (Canada) Dr. Ronald L. Burkes, Mount Sinai Hospital, (416) 586-5117


Permanently Closed
BR12A Phase III Study of Marimastat in Patients with Small Cell Lung Cancer Following a Response to First Line Chemotherapy
A Phase III Study of Marimastat in Patients with Small Cell Lung Cancer Following a Response to First Line Chemotherapy

NCT Registration ID (from clinicaltrials.gov): NCT00003011
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 31, 1997 Closing Date: April 28, 2000

Chair: (Canada) Dr. Frances Shepherd, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4522, (USA) Dr. Guiseppe Giaccone, CCR, National Cancer Institute, NIH, (301) 402-3415


Permanently Closed
BR13 (93-09)A Phase III Comparison Between Concurrent Chemotherapy Plus Radiotherapy and Concurrent Chemotherapy Plus Radiotherapy Followed by Surgical Resection For Stage IIIA (N2) Non-Small Cell Lung Cancer
A Phase III Comparison Between Concurrent Chemotherapy Plus Radiotherapy and Concurrent Chemotherapy Plus Radiotherapy Followed by Surgical Resection For Stage IIIA (N2) Non-Small Cell Lung Cancer

Complexity Level: 2

Eligibility: Patients with histologically proven primary non-small cell lung cancer (T 1-3, N 2-3, M0).

Objectives: To determine if chemotherapy, radiotherapy and surgery is superior to chemotherapy and radiotherapy. To evaluate patterns of local and distant failure.

NCT Registration ID (from clinicaltrials.gov): NCT00002550
Participation: Limited to centres with current CPA #
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: October 15, 1996 Closing Date: November 30, 2001

Chair: (Canada) Dr. Gail Darling, University Health Network, (416) 340-3121


Permanently Closed
BR14 (GEM/VIN 3)A Phase III Study of Gemcitabine Plus Vinorelbine Compared to Standard Cisplatin Containing Chemotherapy For Stage IIIb or IV Non-Small Cell Lung Cancer
A Phase III Study of Gemcitabine Plus Vinorelbine Compared to Standard Cisplatin Containing Chemotherapy For Stage IIIb or IV Non-Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): NCT00004100
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: December 17, 1999 Closing Date: March 15, 2001

Permanently Closed
BR15 (S0023)A Phase III Trial of Cisplatin/Etoposide/Radiotherapy With Consolidation Docetaxel Followed by Maintenance Therapy with ZD1839 or Placebo in Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
A Phase III Trial of Cisplatin/Etoposide/Radiotherapy With Consolidation Docetaxel Followed by Maintenance Therapy with ZD1839 or Placebo in Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer

Eligibility: Either histologic or cytologic proof of a newly diagnosed single, primary bronchogenic non-small cell lung cancer is required (adenocarcinoma, non-lobar and non-diffuse bronchioloalveolar cell carcinoma, large cell carcinoma or squamous cell carcinoma). A biopsy with histology is preferred, but cytology is allowed. Histology or cytology from involved mediastinal or supraclavicular lymph nodes alone will be allowed if a separate distal primary lesion is clearly evident on radiographs (i.e. a second biopsy will not be required).

Objectives: To assess whether cisplatin plus etoposide with concurrent radiotherapy followed by three cycles of consolidation docetaxel followed by maintenance therapy with ZD1839 compared to placebo improves overall survival and progression-free survival in patients with unresectable Stage III non-small cell lung cancer (NSCLC). To describe the toxicity profile of long-term administration of ZD1839.

NCT Registration ID (from clinicaltrials.gov): NCT00020709
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: April 10, 2002 Closing Date: April 15, 2005

Chair: (Canada) Dr. Yee C. Ung, Odette Cancer Centre, (416) 480-4951


Permanently Closed
BR15C (S9925)This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer
This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer

Eligibility: Only patients previously registered to Southwest Oncology Group lung cancer treatment protocols will be registered to this study.

Objectives: To establish a central lung cancer specimen repository to serve as a resource for current and future scientific studies. To utilize the Southwest Oncology Group clinical data base to perform clinicopathologic correlation with the results of those studies. To test new hypotheses as they emerge.

Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: June 15, 2002 Closing Date: April 15, 2005

Chair: (Canada) Dr. Yee C. Ung, Odette Cancer Centre, (416) 480-4951


Permanently Closed
BR17 (08983)Phase III Study of Tomudex and Cisplatin versus Cisplatin in Malignant Pleural Mesothelioma
Phase III Study of Tomudex and Cisplatin versus Cisplatin in Malignant Pleural Mesothelioma

Eligibility: Histologically proven diagnosis of malignant mesothelioma of the pleura. Independent review of the pathology slides will be carried out on all patients.

Objectives: To compare overall survival between the two treatment regimens in patients with malignant pleural mesothelioma. To determine toxicity, progression-free survival and Quality of Life. In the patient population with measurable disease, objective response to treatment and duration of response will be assessed.

NCT Registration ID (from clinicaltrials.gov): NCT00004920
Participation: Not limited
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: February 14, 2000 Closing Date: January 03, 2003

Chair: (Canada) Dr. Mark D. Vincent, London Regional Cancer Program, (519) 685-8640, (Belgium) Dr. Veerle Evrard, EORTC Data Center, (2) 774-1087


Permanently Closed
BR18A Phase II/III Double Blind Randomized Trial of BMS-275291 versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy For the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase II/III Double Blind Randomized Trial of BMS-275291 versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy For the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer

Eligibility: Histologically or cytologically confirmed diagnosis of non-small cell carcinoma of the lung. Cytologic specimens obtained by brushing, washing or needle aspiration of a defined lesion are acceptable. Patients with Stage IIIB or Stage IV NSCLC, or local or metastatic failure after surgery and/or radiotherapy are eligible. Patients with Stage IIIB NSCLC without pleural effusion who are not candidates for combined modality treatment or who are being treated at centres where combined modality treatment is not the standard of practice are also eligible.

Objectives: Phase II - To evaluate the incidence of grade 2 or higher drug related arthritis, arthralgia and/or myalgia in each arm - To estimate the objective tumour response rate in each arm - To evaluate the nature, severity, and frequency of toxicities Phase III Primary Objective: - To compare overall survival (OS) between the 2 arms Secondary Objectives: - To compare progression-free survival (PFS) - To compare response rates (RR) - To estimate time to response and response duration - To compare the nature, severity, and frequency of toxicities between the 2 arms - To correlate the expression of tissue MMP levels (at diagnosis) with outcomes and response to treatment - To correlate serum/plasma MMPs and other markers with outcomes and response to treatment - To compare Quality of Life between the 2 arms - To collect and compare resource utilization for a health economic analysis in North American centres between the 2 treatment arms

NCT Registration ID (from clinicaltrials.gov): NCT00006229
Participation: Limited to European and North American Centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 04, 2000 Closing Date: May 20, 2002

Chair: (Canada) Dr. Frances Shepherd, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4522, (Canada) Dr. Michael Smylie, Cross Cancer Institute, (780) 432-8757, (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645


Permanently Closed
BR19 (BR19)A Phase III Prospective Randomized Double Blind Placebo Controlled Trial of the Epidermal Growth Factor Receptor Antagonist ZD1839 (IRESSA) in Completely Resected Stage 1B, II, and IIIA Non-Small Cell Lung Cancer
A Phase III Prospective Randomized Double Blind Placebo Controlled Trial of the Epidermal Growth Factor Receptor Antagonist ZD1839 (IRESSA) in Completely Resected Stage 1B, II, and IIIA Non-Small Cell Lung Cancer

Eligibility: Patients who have histologic evidence of stage IB, II or IIIA primary non-small cell lung cancer that has been completely resected.

Objectives: To compare whether adjuvant treatment with ZD1839 (IRESSA) is superiour to placebo in patients with completely resected stage IB, II and IIIA non-small cell lung cancer in terms of : overall survival and disease-free survival. To confirm the prognostic significance and to assess the predictive ability of EGFR expression, phosphorylation and mutations and the likelihood of "response" to ZD1839 (IRESSA) in terms of overall survival. A comprehensive tumour bank will be established and linked to the clinical database for the further study of molecular markers in non-small cell lung cancer. The toxicity related to ZD1839 (IRESSA) will be further evaluated.

NCT Registration ID (from clinicaltrials.gov): NCT00049543
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 13, 2002 Closing Date: April 22, 2005

Chair: (USA) Dr. Fadlo R. Khuri, Emory University/ Winship Cancer Institute (RTOG), (404) 778-4250, (USA) Dr. Greg Masters, Medical Oncology Hematology Consultants, PA, (302) 366-1200, (USA) Dr. James R. Jett, NCCTG, Mayo Clinic, (507) 284-3764, (USA) Dr. Martin J. Edelman, Univ. of Maryland - Greenebaum Cancer Centre, (410) 328-2703, (USA) Dr. Peter Roberts, (SWOG) US Naval Medical Center, (757) 953-2451, (USA) Dr. Katherine2 Pisters, M.D. Anderson Cancer Center, (USA) Dr. Hak Choy, (214) 645-7600, (Canada) Dr. Glenwood Goss, Ottawa Hospital Research Institute, (613) 737-8899 Ext. 73955


Permanently Closed
BR2Clinical Trial in Bronchogenic Carcinoma of Specific Immunotherapy as an Adjuvant to Surgery
Clinical Trial in Bronchogenic Carcinoma of Specific Immunotherapy as an Adjuvant to Surgery

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 01, 1978 Closing Date: December 31, 1983

Permanently Closed
BR20A Phase II Study of ZD6474 or Placebo in Small Cell Lung Cancer Patients Who Have Complete or Partial Response to Induction Chemotherapy Plus Radiation Therapy
A Phase II Study of ZD6474 or Placebo in Small Cell Lung Cancer Patients Who Have Complete or Partial Response to Induction Chemotherapy Plus Radiation Therapy

Eligibility: Patients must have histological or cytological proof of small cell carcinoma of the lung. Patients must have achieved a complete or partial response after chemotherapy +/- radiotherapy. Patients must have received a minimum of 4 cycles of the first line combination chemotherapy within 28 days of randomization. Radiology must be performed within 28 days of randomization and must show continued CR or PR. Patients must have a current performance status of ECOG 0, 1 or 2. Patient must have a life expectancy of at least 12 weeks and be 16 years of age or older.aen of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test. Patient is able and willing to complete the quality of life questionnaires in either English or French. Patients registered on this trial must be treated and followed at the participating centres.

Objectives: To compare progression-free survival (PFS) for small cell lung cancer (SCLC) patients who have received either ZD6474 or placebo. To compare the response rate (for patients with measurable disease outside the radiation field at entry) for SCLC patients who have received either ZD6474 or placebo. To compare toxicity and tolerability for SCLC patients who have received either ZD6474 or placebo. To assess pharmacokinetics for SCLC patient who received either ZD6474 or placebo: To compare QoL for SCLC patients who have received either ZD6474 or placebo. To confirm the prognostic significance of VEGFR (? p-VEGFR) expression and microvessel density in tumour with outcomes and response to treatment for consenting patients who had a histological specimen at diagnosis (section 18). To provide a comprehensive tumour, plasma and urine bank (section 17 and 18) linked to a clinical database for the further study of molecular markers in SCLC.

NCT Registration ID (from clinicaltrials.gov): NCT00066313
Participation: Limited to 20 NCIC CTG centres.
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 12, 2003 Closing Date: March 13, 2006

Chair: (Canada) Dr. Andrew Arnold, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 Ext. 64613


Permanently Closed
BR21A Randomized Placebo Controlled Study of OSI-774 (Tarceva) in Patients with Incurable Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease
A Randomized Placebo Controlled Study of OSI-774 (Tarceva) in Patients with Incurable Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease

Eligibility: Incurable stage IIIB/IV non-small cell lung cancer who have failed at least one prior regimen, but no more than two prior regimens for advanced or metastatic disease.

Objectives: To compare overall survival; secondary endpoints include progression-free survival, response rates, duration of response, toxicity and tolerability, QoL QLQ C30 + QLQ LC13: all patients, tissue EGFR versus outcome and response, OSI-744 trough PK.

NCT Registration ID (from clinicaltrials.gov): NCT00026325
Participation: Not limited
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 14, 2001 Closing Date: January 31, 2003

Chair: (Canada) Dr. Frances Shepherd, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4522


Permanently Closed
BR22 (S9900)A Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Paclitaxel/Carboplatin in Clinical Stage IB(T2N0), II(T1-2N1, T3N0) and Selected IIIA(T3N1) Non-Small Cell Lung Cancer.
A Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Paclitaxel/Carboplatin in Clinical Stage IB(T2N0), II(T1-2N1, T3N0) and Selected IIIA(T3N1) Non-Small Cell Lung Cancer.

Complexity Level: 2

Eligibility: Patients must have pathologic documenation of non-small cell lung cancer. Clinical stage IB (T2N0), selected clinical stage II (T1-2N1 with negative mediastinoscopy or T3N0) or selected clinical stage IIIA (T3N1) with negative mediastinoscopies. Level 10 hilar nodes may be positive as long as the mediastinoscopy is negative. All patients must have measurable disease.

Objectives: To assess whether preoperative chemotherapy with paclitaxel and carboplatin for 3 cycles improves survival compared to surgery alone in previously untreated patients with clinical Stage 1B II and Selected III A non-small cell lung cancer (NSCLC). To compare operative mortality and other toxicities in the two study arms. To evaluate the response rates (confirmed and unconfirmed, complete and partial) and the toxicities associated with the combination of paclitaxel and carboplatin. To obtain samples for correlation of pathologic, molecular and biologic factors with outcome.

NCT Registration ID (from clinicaltrials.gov): NCT00004011
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: March 26, 2002 Closing Date: July 15, 2004

Chair: (Canada) Dr. Peter Ellis, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495


Permanently Closed
BR22C (S9925)This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer
This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer

Eligibility: Only patients previously registered to Southwest Oncology Group lung cancer treatment protocols will be registered to this study.

Objectives: To establish a central lung cancer specimen repository to serve as a resource for current and future scientific studies. To utilize the Southwest Oncology Group clinical data base to perform clinicopathologic correlation with the results of those studies.

Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: March 26, 2002 Closing Date: July 15, 2004

Chair: (Canada) Dr. Peter Ellis, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495


Permanently Closed
BR23 (S0220)A Phase II Trial of Induction Chemoradiotherapy with Cisplatin/Etoposide Followed by Surgical Resection, Followed by Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumours)
A Phase II Trial of Induction Chemoradiotherapy with Cisplatin/Etoposide Followed by Surgical Resection, Followed by Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumours)

Complexity Level: 2

Eligibility: Histologically confirmed newly diagnosed single primary bronchogenic NSCLC,selected Stage IIB,IIIA or IIIB due to involvement of superior sulcus(T3-4,NO-1).EKG.Evidence of disease by chest x-ray (PA & lateral views),chest CT preferable w/contrast)with bone windows,CT scan of upper abd or PET scan (not necessary if chest CT incl.liver and adrenals).Biopsy or aspiration of suspicious CT/MRI findings.Pleural effusion negative per Section 5.5.Pre-resection FEV1 greater than or equal to 2.0 L,or if FEV1 less than 2.0,predicted post-resection FEV1 greater than 1.0L. PS 0-2 (PS2 must have albuin greater than or equal to 0.85 x 1LLN, wt loss less than or equal to 10%).ANC greater than or equal to 1,500,PLTS greater than or equal to 100,000.Adequate hepatic function,total bili & SGOT or SGPT less than or equal to 1.5 x 1ULN (unless benign dz present).CrCl greater than or equal to 50 ml/min. Must have mediastinal exploration w/lymph nodes biopsied except if mediastinum neg by both CT/PET.

Objectives: The main objective of this Phase II study is to assess whether a regimen of cisplatin and etoposide with concurrent RT, followed by surgical resection and consolidation therapy with docetaxel has promise in terms of its feasibility for treating patients with Pancoast tumours Stage IIIA.

NCT Registration ID (from clinicaltrials.gov): NCT00062439
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: February 10, 2004 Closing Date: October 01, 2007

Chair: (Canada) Dr. Gad A. Perry, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70215, (Canada) Dr. Thomas Waddell, Univ. Health Network-The Toronto General Hospital, (416) 340-3432, (Canada) Dr. Scott Laurie, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70173


Permanently Closed
BR23C (S9925)This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer
This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer

Eligibility: Only patients previously registered to Southwest Oncology Group lung cancer treatment protocols will be registered to this study.

Objectives: To establish a central lung cancer specimen repository to serve as a resource for current and future scientific studies. To utilize the Southwest Oncology Group clinical database to perform clinicopathologic correlation with the results of those studies. To test a new hypotheses as they emerge.

Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: February 10, 2004 Closing Date: October 01, 2007

Chair: (Canada) Dr. Thomas Waddell, Univ. Health Network-The Toronto General Hospital, (416) 340-3432


Permanently Closed
BR24A Phase II/III Double Blind Randomized Trial of AZD2171 versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase II/III Double Blind Randomized Trial of AZD2171 versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer

Complexity Level: 2

Eligibility: Histologically or cytologically confirmed diagnosis of stage IIIB or stage IV NSCLC. For phase II, the first 150 patients must have unidimensionally measurable disease by RECIST criteria. Prior adjuvant chemotherapy permitted (completed >=12 months), prior EGFR inhibitor therapy permitted (completed >=14 days). No prior anti-angiogenesis therapy permitted, no prior chemotherapy for metastatic or recurrent disease permitted. Patients must be > 21 days since radiation therapy and > 14 days since previous surgery.

Objectives: Phase II: To compare the progression-free survival between arms. To compare the objective tumour response rate in each arm. To evaluate the nature, severity, and frequency of toxicities, including hemorrhage and hemoptysis between the two arms. To examine pharmacogenomic and pharmacodynamic aspects of treamtent. Phase III: To compare overall survival between the two arms. To compare progression-free survival between arms. To compare objective response rates (RR) in each arm. To estimate time to response and response duration. To evaluate the nature, severity, and frequency of toxicities, including hemorrhage and hemoptysis between the two arms. To correlate the expression of tissue markers (at diagnosis) with outcomes and response. To compare Quality of Life between the two arms.

NCT Registration ID (from clinicaltrials.gov): NCT00245154
Participation: Limited to invited centres only.
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 07, 2005 Closing Date: February 25, 2008

Chair: (Canada) Dr. Glenwood Goss, Ottawa Hospital Research Institute, (613) 737-8899 Ext. 73955, (Canada) Dr. Scott Laurie, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70173


Permanently Closed
BR25A Phase II Study of Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT)For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)
A Phase II Study of Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT)For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)

Complexity Level: 1

Eligibility: Histological or cytological confirmation of non-small cell lung cancer The following primary cancer types:squamous cell,adenocarcinoma, large cell, bronchioloalveolar cell, or non-small cell carcinoma not otherwise specified. If sputum cytology alone is used for diagnosis, this should be confirmed on a second specimen. Cytologic specimens obtained by brushing, washing or needle aspiration of a defined lesion are acceptable.

Objectives: To measure the local tumour control rate at 2 years after the delivery of an accelerated hypofractionated course of radiotherapy to patients with stage I/II (peripheral T1-3, N0, M0) non-small cell lung cancer (NSCLC). To measure the toxicities associated with the treatment, the rates of regional and distant recurrence, progression-free survival and overall survival,the changes in pulmonary function after treatment. To assess quality of life (QOL) after treatment.

NCT Registration ID (from clinicaltrials.gov): NCT00346320
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 26, 2006 Closing Date: April 18, 2008

Chair: (Canada) Dr. Patrick C.F. Cheung, Odette Cancer Centre, (416) 480-6165


Permanently Closed
BR26A Double Blind Placebo Controlled Randomized Trial of PF-804 in Patients With Incurable Stage IIIB/IV Non-small Cell Lung Cancer After Failure of Standard Therapy for Advanced or Metastatic Disease
A Double Blind Placebo Controlled Randomized Trial of PF-804 in Patients With Incurable Stage IIIB/IV Non-small Cell Lung Cancer After Failure of Standard Therapy for Advanced or Metastatic Disease

Complexity Level: 2

Eligibility: Advanced previously treated Non-Small Cell Lung Cancer

Objectives: Progression free survival and Overall survival

NCT Registration ID (from clinicaltrials.gov): NCT01000025
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 04, 2009 Closing Date: June 13, 2013

Chair: (Canada) Dr. Peter Ellis, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495


Permanently Closed
BR29A Double Blind Randomized Trial of Cediranib versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer
A Double Blind Randomized Trial of Cediranib versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer

Complexity Level: 2

Objectives: This is a randomized, double blind, placebo controlled study of cediranib (AZD2171) given in combination with standard paclitaxel/carboplatin chemotherapy in patients with stage IIIB or IV non-small cell lung cancer. An early futility interim analysis is planned. Primary objective: To compare the overall survival between the 2 arms

NCT Registration ID (from clinicaltrials.gov): NCT00795340
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 06, 2008 Closing Date: May 06, 2011

Chair: (Australia) Dr. Benjamin Solomon, Peter McCallum Cancer Institute, (131) 9656-1517, (Australia) Dr. Martin Stockler, Royal Prince Alfred Hospital, (2) 9515-5494, (Canada) Dr. Scott Laurie, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70173


Permanently Closed
BR3Clinical Trial of Alternating versus Sequential Combination Chemotherapy and Loco-regional Chemotherapy for the Treatment of Limited Small Cell Carcinoma of the Lung
Clinical Trial of Alternating versus Sequential Combination Chemotherapy and Loco-regional Chemotherapy for the Treatment of Limited Small Cell Carcinoma of the Lung

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 01, 1981 Closing Date: October 01, 1984

Permanently Closed
BR4Clinical Trial of Standard versus Alternating Combination Chemotherapy for the Treatment of Extensive Small Cell Carcinoma of the Lung
Clinical Trial of Standard versus Alternating Combination Chemotherapy for the Treatment of Extensive Small Cell Carcinoma of the Lung

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 11, 1982 Closing Date: April 01, 1985

Permanently Closed
BR5A) Clinical Trial of Two Regimens of Combination Chemotherapy Compared to Best Supportive Care or B) Clinical Trial of Two Regimens of Combination Chemotherapy for the Treatment of Extensive Non-small Cell Carcinoma of the Lung
A) Clinical Trial of Two Regimens of Combination Chemotherapy Compared to Best Supportive Care or B) Clinical Trial of Two Regimens of Combination Chemotherapy for the Treatment of Extensive Non-small Cell Carcinoma of the Lung

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 22, 1982 Closing Date: January 01, 1986

Permanently Closed
BR6A Clinical Trial of Early Versus Late Radiotherapy for Treatment of Limited Small Cell Carcinoma of the Lung
A Clinical Trial of Early Versus Late Radiotherapy for Treatment of Limited Small Cell Carcinoma of the Lung

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 15, 1985 Closing Date: December 16, 1988

Permanently Closed
BR7A Pilot Study of Radiotherapy Fractionation for the Treatment of Limited Small Cell Carcinoma of the Lung
A Pilot Study of Radiotherapy Fractionation for the Treatment of Limited Small Cell Carcinoma of the Lung

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 15, 1987 Closing Date: May 17, 1988

Permanently Closed
BR8A Randomized Phase III Study of CODE Plus Thoracic Irradiation Versus Alternating CAV and EP for Extensive Stage Small Cell Lung Cancer
A Randomized Phase III Study of CODE Plus Thoracic Irradiation Versus Alternating CAV and EP for Extensive Stage Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 16, 1992 Closing Date: April 26, 1996

Chair: (USA) Dr. Robert Livingston, Arizona Cancer Center (SWOG), (520) 626-2816


Permanently Closed
BR9A Phase III Prospective Randomized Study of Combination Chemotherapy and Surgery Versus Radiotherapy for Stage IIIA Non-Small Cell Lung Cancer
A Phase III Prospective Randomized Study of Combination Chemotherapy and Surgery Versus Radiotherapy for Stage IIIA Non-Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 05, 1993 Closing Date: November 03, 1994

Chair: (Canada) Dr. Frances Shepherd, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4522


Permanently Closed
BRC1 (RTOG 0214)A Phase III Comparison of Prophylactic Cranial Irradiation Versus Observation in Patients With Locally Advanced Non-Small Cell Lung Cancer
A Phase III Comparison of Prophylactic Cranial Irradiation Versus Observation in Patients With Locally Advanced Non-Small Cell Lung Cancer

Complexity Level: 2

Eligibility: Patients with Stage IIIA or IIIB non-small cell lung cancer having completed all planned definitive locoregional therapy (chemotherapy alone does not constitute definitive therapy) or locoregional and systemic therapy (with or without surgery) with complete response, partial response or stable disease after therapy. Eligible patients must have had an MRI or CT scan of the head showing no suspicion for CNS metastases within 6 weeks of study entry. Patients will not be eligible for the study if there is evidence of progressive disease, extracranial distant metastatic disease or if treated with prior cranial irradiation

Objectives: To determine whether prophylactic cranial irradiation (PCI) improves survival after effective locoregional/systemic therapy for patients with locally advanced non-small cell lung cancer. To determine the neurolopsychologic impact of PCI, the impact of PCI on quality of life, and the impact of PCI on the incidence of CNS metastases.

NCT Registration ID (from clinicaltrials.gov): NCT00048997
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: October 04, 2002 Closing Date: August 30, 2007

Chair: (Canada) Dr. Alexander Y. Sun, University Health Network, (416) 946-2126


Permanently Closed
BRC3 (S0124)Randomized Phase III Trial of Cisplatin and Irinotecan (NSC-616348) Versus Cisplatin and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC)
Randomized Phase III Trial of Cisplatin and Irinotecan (NSC-616348) Versus Cisplatin and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC)

Eligibility: Histologic/cytologic confirmed E-SCLC Measurable or non-measurable disease Performance status: 0-1 Patient must be at least 3 weeks post surgery Patients with brain mets eligible only of controlled Blood counts and liver function test results must be within range provided in protocol.

Objectives: Compare the survival of patients with extensive stage small cell lung cancer (E-SCLC) treated with cisplatin & irinotecan vs cisplatin and & compare progression-free survival, toxicities and response rate in patients with E-SCLC treated with cisplatin and irinotecan versus cisplatin and etoposide. Assess the association between UGT1A1 polymorphisms and irinotecan-associated toxicities in patients with E-SCLC. Assess the association between ERCC-1 and XRCC-1 polymorphisms and non-response to cisplatin & irinotecan & to cisplatin and etoposide.

NCT Registration ID (from clinicaltrials.gov): NCT00045162
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: March 12, 2004 Closing Date: March 01, 2007

Permanently Closed
BRC4 (N0723)A Phase III Biomarker Validation Study of Second-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Randomized to Pemetrexed Versus Erlotinib
A Phase III Biomarker Validation Study of Second-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Randomized to Pemetrexed Versus Erlotinib

Eligibility: Documented recurrence or disease progression of NSCLC Measurable disease of at least 2cm; ECOG PS = 0, 1 or 2; Negative pregnancy test; Ability to provide informed consent; Life expectancy > 12wks; Tissue available and willing to submit tissue for EGFR evaluation; Must be previously treated for advanced disease with only 1 chemotherapy regimen which must contain cytotoxic agent(s); Able to take folic acid, vitamin B12 supplementation, and dexamethasone; Able to permanently discontinue aspirin dose of greater or equal to 1.3 grams/day 10 days before and after pemetrexed treatment; Stable brain mets; Willingness to return to enrolling institution for treatment and follow-up.

Objectives: Primary: To evaluate whether there are differences in progression free survival due to treatment with erlotinib compared to pemetrexed for subsets of previously treated NSCLC patients defined by epidermal growth factor receptor (EGFR)-FISH positivity versus negativity

NCT Registration ID (from clinicaltrials.gov): NCT00738881
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: May 14, 2009 Closing Date: November 13, 2009

Chair: (Canada) Dr. Geoffrey Liu, University Health Network, (416) 946-4501 Ext. 3428


Permanently Closed
I11NCIC CTG Phase II Study of TCAR in Lung
NCIC CTG Phase II Study of TCAR in Lung

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 01, 1985 Closing Date: March 01, 1987

Permanently Closed
I110NCIC CTG Phase II Study of Multi-Targeted Anti-Folate (MTA) LY231514 in Combination With Cisplatin in Patients With Advanced Non-Small Cell Lung Cancer
NCIC CTG Phase II Study of Multi-Targeted Anti-Folate (MTA) LY231514 in Combination With Cisplatin in Patients With Advanced Non-Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 15, 1998 Closing Date: June 07, 1999

Chair: (Canada) Dr. Frances Shepherd, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4522


Permanently Closed
I114NCIC CTG Phase II Study of Vasopression Receptor Type 1-A Antagonist SR49059 in Patients With Previously Treated Small Cell Lung Cancer
NCIC CTG Phase II Study of Vasopression Receptor Type 1-A Antagonist SR49059 in Patients With Previously Treated Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 05, 1999 Closing Date: October 20, 2000

Permanently Closed
I120A Phase II Study of Troxacitabine in Patients With Advanced Non-Small Cell Lung Cancer
A Phase II Study of Troxacitabine in Patients With Advanced Non-Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCt
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 16, 1999 Closing Date: May 30, 2000

Chair: (Canada) Dr. Susan Dent, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70167


Permanently Closed
I17NCIC CTG Phase I Study of Acivicin/Cisplatin in Non-Small Cell Lung Cancer
NCIC CTG Phase I Study of Acivicin/Cisplatin in Non-Small Cell Lung Cancer

NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 01, 1985 Closing Date: April 25, 1988

Permanently Closed
I183A Phase II Study Of Sunitinib In Patients With Advanced Malignant Pleural Mesothelioma
A Phase II Study Of Sunitinib In Patients With Advanced Malignant Pleural Mesothelioma

Eligibility: Patients with histological or cytological documented malignant pleural mesothelioma (advanced or metastatic disease). There will be two groups: Cohort 1 - previously treated patients: minimum of one prior platinum based chemotherapy, and Cohort 2 - previously untreated patients: No prior cytotoxic therapy permitted.

Objectives: To assess the efficacy (response rate, complete and partial) of sunitinib given orally daily for 4 out of every 6 weeks in patients with malignant pleural mesothelioma in two cohorts: in patients previously treated with cytotoxic therapy (cohort 1) and in patients who have not received previous cytotoxic therapy (cohort 2). To assess the toxicity safety and tolerability of sunitinib. To assess the duration of response or stable disease, stable disease rate, progression-free, median and overall survival rates

NCT Registration ID (from clinicaltrials.gov): NCT00392444
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 10, 2006 Closing Date: September 10, 2010

Chair: (Canada) Dr. Scott Laurie, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70173


Permanently Closed
I190A Phase I-II Trial of MK-0646, a Monoclonal Antibody Against Insulin-Like Growth Factor-1 Receptor, in Combination with Etoposide and Cisplatin in Extensive Stage Small Cell Lung Cancer.
A Phase I-II Trial of MK-0646, a Monoclonal Antibody Against Insulin-Like Growth Factor-1 Receptor, in Combination with Etoposide and Cisplatin in Extensive Stage Small Cell Lung Cancer.

Eligibility: Patients with histologically confirmed, extensive stage small cell lung cancer. No prior chemotherapy for SCLC. Prior radiation permitted to brain but not to lung. No uncontrolled diabetes or cardiac conditions and acceptable end-organ function. ECOG 0, 1 or 2. Unidimensionally measurable disease.

Objectives: 1.1 Phase I Objectives 1.1.1 To determine the recommended phase II dose of MK-0646 in combination with a standard etoposide and cisplatin (EP) chemotherapy regimen. 1.1.2 Evaluate the toxicity and preliminary efficacy of the combination. 1.2 Phase II Objectives 1.2.1 To assess the efficacy, as determined by objective response rate; including complete response rate, progression-free survival and overall survival. 1.2.2 To assess the toxicity and tolerability. 1.2.3 Explore the predictive and prognostic impact of biomarkers.

NCT Registration ID (from clinicaltrials.gov): NCT00869752
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 30, 2009 Closing Date: March 10, 2011

Chair: (Canada) Dr. Peter Ellis, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495


Permanently Closed
I196A Phase I/II Study of Foretinib in Patients with Previously Treated Non-Small Cell Lung Cancer Receiving Standard Erlotinib Therapy (IND.196)
A Phase I/II Study of Foretinib in Patients with Previously Treated Non-Small Cell Lung Cancer Receiving Standard Erlotinib Therapy (IND.196)

Complexity Level: 1

Eligibility: Patients with locally advanced or metastatic non-small cell lung cancer who have failed at least one prior chemotherapy regimen for advanced or metastatic disease. No more than 2 prior chemotherapy regimens for advanced or metastatic disease. EGFR status positive or unknown. Unidimensionally measurable disease. Archival tissue or fresh biopsy/FNA required at study entry.

Objectives: To determine the safety, tolerability, toxicity profile, dose limiting toxicities, pharmacokinetic profile and the recommended phase II dose of Foretinib in combination with standard erlotinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen, and whose EGFR expression status is positive or unknown. To assess the anti-tumour activity of Foretinib in combination with erlotinib as evidenced by response rates, clinical benefit (complete or partial response or stable disease > 8 weeks duration), survival and an exploratory endpoint of early assessment of tumour size as a continuous variable, when compared to erlotinib alone. To correlate response with various biomarkers.

NCT Registration ID (from clinicaltrials.gov): NCT01068587
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 17, 2009 Closing Date: January 24, 2013

Chair: (Canada) Dr. Cheryl Ho, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2445, (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645


Permanently Closed
I207A Phase II Study of PF-03446962 in Patients with Advanced Malignant Pleural Mesothelioma
A Phase II Study of PF-03446962 in Patients with Advanced Malignant Pleural Mesothelioma

Complexity Level: 2

Eligibility: histologically or cytologically confirmed malignant pleural mesothelioma; advanced and/or metastatic disease; at least one site of disease must be unidimensionally measurable; patients are eligible after first line cytotoxic chemotherapy has failed; patients must have received one, but no more than one, combination chemotherapy regimen for advanced disease, which must have contained platinum based chemotherapy

Objectives: To assess the efficacy of PF-03446962 given by IV day 1 of a 2 week cycle in patients with advanced malignant pleural mesothelioma; to assess the toxicity, safety and tolerability of PF-03446962; to assess the duration of response or stable disease, stable disease rate, progression free, median and overall survival rates; to collect tissue and blood for banking and correlative science evaluation.

NCT Registration ID (from clinicaltrials.gov): NCT01486368
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Permanently Closed
Activation Date: November 30, 2011 Closing Date: January 09, 2014

Chair: (Canada) Dr. Paul Wheatley-Price, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 79859, (Canada) Dr. Quincy Chu, Cross Cancer Institute, (780) 432-8248


Permanently Closed
I2LNCIC CTG Phase II Study of Acivicin (AT125) in Patients With Metastatic Non-Small Cell Lung Cancer
NCIC CTG Phase II Study of Acivicin (AT125) in Patients With Metastatic Non-Small Cell Lung Cancer

NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 03, 1981 Closing Date: March 09, 1984

Permanently Closed
I30NCIC CTG Phase II Study of VP-16/Cisplatin in Mesothelioma
NCIC CTG Phase II Study of VP-16/Cisplatin in Mesothelioma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 09, 1986 Closing Date: April 01, 1987

Permanently Closed
I31NCIC CTG Phase II Study of VP-16/Carboplatin in Extensive Small Cell Lung Cancer
NCIC CTG Phase II Study of VP-16/Carboplatin in Extensive Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 18, 1985 Closing Date: October 09, 1986

Permanently Closed
I33NCIC CTG Phase II Study of Epirubicin in Small Cell Lung Cancer
NCIC CTG Phase II Study of Epirubicin in Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 29, 1986 Closing Date: July 31, 1987

Permanently Closed
I42NCIC CTG Phase II Study of Amonafide in Small Cell Lung Cancer
NCIC CTG Phase II Study of Amonafide in Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 23, 1987 Closing Date: April 25, 1988

Permanently Closed
I47NCIC CTG Phase II Study of LY186641 in Small Cell Lung Cancer
NCIC CTG Phase II Study of LY186641 in Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 25, 1989 Closing Date: November 30, 1990

Permanently Closed
I50NCIC CTG Phase II Study of Gemcitabine in Small Cell Lung Cancer
NCIC CTG Phase II Study of Gemcitabine in Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 04, 1991 Closing Date: September 29, 1992

Permanently Closed
I52NCIC CTG Phase I Study of GMCSF in Small Cell Lung Cancer
NCIC CTG Phase I Study of GMCSF in Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 06, 1989 Closing Date: September 19, 1990

Permanently Closed
I57NCIC CTG Phase II Study of DUP937 in Non-Small Cell Lung Cancer
NCIC CTG Phase II Study of DUP937 in Non-Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 04, 1991 Closing Date: April 02, 1992

Permanently Closed
I65NCIC CTG Phase II Study of Elsamitrucin in Patients With Non-Small Cell Lung Cancer
NCIC CTG Phase II Study of Elsamitrucin in Patients With Non-Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 01, 1992 Closing Date: December 04, 1992

Permanently Closed
I66Phase II Study of Interferon Alfa-2a and 13-cis-retinoic Acid in Patients With Non-Small Cell Lung Cancer
Phase II Study of Interferon Alfa-2a and 13-cis-retinoic Acid in Patients With Non-Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 15, 1992 Closing Date: May 28, 1993

Permanently Closed
I69NCIC CTG Phase II Study of Taxotere in Patients With Extensive Small Cell Lung Cancer
NCIC CTG Phase II Study of Taxotere in Patients With Extensive Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 08, 1993 Closing Date: October 18, 1993

Permanently Closed
I7NCIC CTG Phase II Study of Mitoxantrone in Mesothelioma
NCIC CTG Phase II Study of Mitoxantrone in Mesothelioma

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 12, 1983 Closing Date: February 15, 1985

Permanently Closed
I79NCIC CTG Phase I/II Study of Taxol and Ifosfamide in Advanced Non-Small Cell Lung Cancer
NCIC CTG Phase I/II Study of Taxol and Ifosfamide in Advanced Non-Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 13, 1993 Closing Date: February 08, 1996

Chair: (Canada) Dr. Frances Shepherd, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4522


Permanently Closed
I80NCIC CTG Phase I Study of Taxol and Concurrent Radiotherapy in Non-Small Cell Lung Cancer
NCIC CTG Phase I Study of Taxol and Concurrent Radiotherapy in Non-Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 14, 1994 Closing Date: June 14, 1996

Permanently Closed
I81NCIC CTG Phase II Study of Tallimustine in Patients With Previously Treated Small Cell Lung Cancer
NCIC CTG Phase II Study of Tallimustine in Patients With Previously Treated Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 16, 1994 Closing Date: June 14, 1995

Permanently Closed
I89NCIC CTG Phase II Study of LY231514 in Patients With Non-Small Cell Lung Cancer
NCIC CTG Phase II Study of LY231514 in Patients With Non-Small Cell Lung Cancer

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 12, 1995 Closing Date: February 04, 1997

Chair: (Canada) Dr. James Rusthoven, (905) 648-7936


Permanently Closed