Thoracic Disease Site

Complexity Level: 2

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

Chair: (Canada) Dr. Jacques Antoun Raphael, London Regional Cancer Program, (519) 685-8640

Complexity Level: 2

Eligibility: Eligibility: MAIN INCLUSION CRITERIA: Patients with metastatic NSCLC that is EGFR and ALK mutation negative, PD-L1 expression Tumour Proportion Score (TPS) ≥ 50% who are willing and able to receive continued pembrolizumab or addition of standard platinum-based combination therapy added to pembrolizumab after initial 6 weeks (after 2 Q3W doses or 1 Q6W dose) of pembrolizumab as systemic immunotherapy. ECOG 0-2. Clinically/radiologically evaluable disease, RECIST 1.1 measurable disease not required. Mandatory blood collection of ctDNA for screening. MAIN EXCLUSION CRITERIA: Symptomatic/unstable CNS metastases. Patients who are not suitable candidates for treatment with pembrolizumab as a single agent or in combination with standard platinum combination chemotherapy.

Objectives: Primary: Phase II progression free survival (PFS), Phase III overall survival (OS). Secondary: Phase II feasibility, RECIST response rate post randomization, safety/tolerability; Phase III RECIST response rate post randomization, response duration, progression free survival, and safety/tolerability.

NCT Registration ID (from clinicaltrials.gov): NCT04093167
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: October 17, 2019

Chair: (Canada) Dr. Sara Moore, Ottawa Hospital Research Institute, (613) 737-7700, (USA) Valsamo Anagnostou, The Sidney Kimmel Comprehensive Cancer Centre, (410) 502-3696

Complexity Level: 2

Eligibility: Participants with metatstatic, histologically confirmed non-small cell lung cancer, without an actionable driver mutataion, for whom either immune checkpoint inhibition (ICI) alone or in combination with chemotherapy is indicated. Participants must have oligoprogression on first-line ICI +/- chemotherapy after at least 3 cycles. All sites of oligopregression must be amenable to treatment with stereotactic body radiation therapy (SBRT) or ablative radiotherapy.

Objectives: 1) To evaluate if the addition of SBRT to extra-cranial oligoprogressive metastatic disease can prolong progression-free survival (PFS) and/or overall survival (OS) compared to SOC systemic therapy alone in participants with oligoprogressive NSCLC. 2) To evaluate both treatment strategies with respect to: Safety and tolerability (using CTCAE Version 5.0); Participant-reported adverse events (using PRO-CTCAE questionnaire); Participant-reported quality of life (using EORTC-QLQ-C30 and QLQ-LC13 questionnaires); Cost-effectiveness (using EQ-5D-5L questionnaire; CCTG Canadian sites only) 3) To determine biomarkers of response and resistance using peripheral blood and tissue samples.

NCT Registration ID (from clinicaltrials.gov): NCT06686771
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: April 03, 2025

Chair: (Canada) Dr. Chiaojung Jillian Tsai, University Health Network, (416) 946-4501

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).

Objectives: Primary Objective: Disease free survival (DFS) for patients with NSCLC that is PD-L1 positive. Disease free survival (DFS) in all randomized patients. Secondary Objectives: 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: Closed to Accrual
Activation Date: October 09, 2014 Closing Date: March 27, 2020

Chair: (Canada) Dr. Gail Darling, QEII Health Sciences Centre, (Italy) Dr. Francesco Perrone, Istituto Nazionale Tumori, (81) 590-3571, (Canada) Dr. Glenwood Goss, Ottawa Hospital Research Institute, (613) 737-8899 Ext. 73955, () Dr. Yi-Long Wu, Chinese Thoracic Oncology Group

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. - stage IVA or IVB per TNM version 8 staging criteria - 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: Closed to Accrual
Activation Date: February 15, 2017 Closing Date: November 07, 2018

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

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

Complexity Level: 2

Eligibility: Patients must have histologically or cytologically confirmed stage IV non-squamous NSCLC (includes M1a, M1b, and M1c stage disease. Patients with T4NX disease (Stage IIIB) with nodule in ipsilateral lung lobe are eligible if they are not candidates for combined chemotherapy and radiation. Patients must have PD-L1 expression Tumor Proportion Score (TPS)greater than or equal to 1% in tumor cells. Patients must have measurable or non-measureable disease.

Objectives: Co-primary objective is to evaluate overall survival (OS) in each of the 2 experimental arms (Arms A and B) to control (Arm C). To evaluate progression-free survival (PFS) for Arm C versus each of Arms A and B; best objective response rates for Arm C versus each of Arms A and B; to estimate toxicity within each of the treatment arms via the CTCAE criteria, compare outcomes b/w Arms A & B, and outcomes by treatment arm within subgroups defined by a cutpoint of PD-L1 expression at > 50%.

NCT Registration ID (from clinicaltrials.gov): NCT03793179
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: July 10, 2019 Closing Date: March 01, 2024

Chair: (Canada) Dr. Andrew Robinson, Cancer Centre of Southeastern Ontario at Kingston, (613) 549-6666 Ext. 8104

Complexity Level: 2

Eligibility: Disease Related Criteria: a) Patient must have a histologically confirmed diagnosis of small-cell lung cancer(SCLC). b) Patient must have an MRI of the brain performed within 28 days prior to registration documenting no evidence of brain metastases or leptomeningeal disease. Patient also must not have a history of brain metastases or leptomeningeal disease. Prior/Concurrent Therapy Criteria: a) Immunotherapy concurrent with and/or adjuvant to first-line therapy is allowed at the discretion of the treating pysician. b) All adverse events from prior treatment must have resolved to Grade 2 (CTCAE Version 5.0) prior to randomization. c) Patient must have had a response to first-line therapy and no evidence of progression in opinion of the treating investigator. d) No more then 8 weeks elapsed between D1 of last cycle of chemotherapy and radomization e) Patient must not have received prior radiotherapy to the brain or WBRT.

Objectives: Primary Objective: To evaluate whether overall survival (OS) with MRI surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC). Secondary Objectives: To compare cognitive failure free survival (CFFS) rate up to 12 months after randomization between the arms. To compare brain-metastasis-free survival between the arms. To compare OS between the arms within the subgroups of patients with limited-stage and extensive-stage disease. To compare cognitive failure free survival (CFFS) rates at the assessment times between the arms. To compare the cumulative incidence of cognitive failure with death as a competing risk between the arms. To compare the frequency and severity of toxicities between the two arms. Additional Objectives: To collect blood for banking.

NCT Registration ID (from clinicaltrials.gov): NCT04155034
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: May 27, 2020 Closing Date: December 11, 2025

Chair: (Canada) Dr. Jonathan Greenland, Dr. H. Bliss Murphy Cancer Centre, (709) 777-7802

Complexity Level: 1

Eligibility: Histologically confirmed diagnosis of primary NSCLC within 90 days of enrollment to a substudy, according to WHO/ classified as Stage IA2 to IIIA according to the AJCC 8th edition TNM classification with disease that is amenable to anatomical surgical resection. Patients with multistation N2.; must be ≥ 18 years of age. No prior anticancer therapy for treatment of NSCLC. Patients with a history of NSCLC treated in the curative setting may be eligible but must be discussed with CCTG prior to enrollment, ECOG performance status of 0 or 1; synchronous primary tumours may be eligible if all of the following conditions are met:, surgery must be performed between 2 to 4 weeks following the last dose of neoadjuvant therapy, adequate organ and marrow function.

Objectives: To identify promising neoadjuvant treatment regimens for NSCLC for later validation in randomized clinical trials, by evaluating major pathological response rates (MPR). Secondary, to summarize the safety and tolerability of each regimen and to evaluate other indicators of activity such as: Overall response rate (ORR) using RECIST 1.1 (and other criteria such as iRECIST as applicable) for neoadjuvant treatment period; Complete pathological response (cPR) rate; Event-free survival rate at 2 years; and Surgical outcomes, including completeness of surgical resection, extent and access to surgery, extent of perihilar/lobar fibrosis or mediastinal adhesions and tumour downstaging. Exploratory include: To identify potential predictive biomarkers of response and mechanisms of resistance, and explore patient related outcomes (PRO).

NCT Registration ID (from clinicaltrials.gov): NCT05714891
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: May 26, 2023 Closing Date: December 16, 2024

Chair: (Canada) Dr. Normand Blais, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8444, (Canada) Dr. Jonathan Spicer, The Research Institute of the McGill University, (514) 934-1934 Ext. 43050

Complexity Level: 1

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: May 26, 2023 Closing Date: May 08, 2024

Chair: (Canada) Dr. Jonathan Spicer, The Research Institute of the McGill University, (514) 934-1934 Ext. 43050, (Canada) Dr. Normand Blais, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8444