Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer
Status:
Completed
Trial end date:
2020-12-21
Target enrollment:
Participant gender:
Summary
This is a Phase II, open-label, 4-cohort study of the monoclonal antibody BGB-A317 in
combination with standard platinum-based chemotherapy in participants with advanced NSCLC or
SCLC. The 4 cohorts will be enrolled concurrently including non-squamous NSCLC Cohort,
squamous NSCLC Cohort A, squamous NSCLC Cohort B and SCLC Cohort. Participants with a mixed
adenocarcinoma and squamous cell NSCLC will be allocated to one of the NSCLC cohorts based on
the predominant histopathological profile. (e.g., participants with adenocarcinoma component
accounting for > 50% will be allocated to non-squamous NSCLC cohort.). Participants with
squamous NSCLC will be sequentially enrolled into either of the 2 squamous NSCLC cohorts by
the trial stage i.e. the sequence of the enrollment for the squamous NSCLC cohorts will be as
Cohort A safety run-in Stage, followed by Cohort B safety run-in Stage, Cohort A
dose-expansion stage and Cohort B dose-expansion Stage.