Wednesday, July 24, 2019 BRC7 trial has been centrally activated, this is a Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Post Progression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker Signature-driven Analysis Activation Date: July 10, 2019 NCT Registration ID: NCT03793179 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%. Visit the CCTG BRC7 trial page for more information.
