Canadian Cancer Trials Group Bulletins

Trial Management Group

Trial Activation

BR.34: A Randomized Trial of Durvalumab (MEDI4736) and Tremelimumab +/- Platinum-Based Chemotherapy in Patients with Metastatic (Stage IV) Squamous or Non-Squamous Non-Small Cell Lung Cancer (NSCLC) is centrally activated.

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

This trial is currently open to accrual at all member centres.

Please contact the Study Coordinator: Andrea Hiltz for more information.