Status: Closed
Activation Date: 2017FEB15
Closing Date: 2018NOV07
Phase: II
Description: A Randomized Trial of Durvalumab and Tremelimumab +/- Platinum Based Chemotherapy in Patients with Metastatic (Stage IV) Squamous or Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
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
Objective: 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
Participation: Open to member centres
Lay Description: This is an international, multicentre, randomized, Phase II, trial that compares immunotherapy alone vs immunotherapy plus chemotherapy in patients with metastatic, non-small cell lung cancer. BR.34 will collect important information regarding patients' quality of life and the side effects of treatment. The researchers will also be doing tests on blood and tumour samples from participants to look for certain proteins and immune cells which may help predict which patients in the future are most likely benefit from the study drugs.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| LUNG | BR34 | 301 | 163 | 282 | 295 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| LUNG | BR34 | 301 | 1 | 6 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| LUNG | BR34 | 301 | 299 | 0 | 0 | 0 | 299 | 298 | 0 | 0 |