drugset / Trial / NCT04139317

Safety and Efficacy of Capmatinib (INC280) Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1≥ 50%

NCT04139317

Phase 2 Terminated 76 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose was to evaluate the efficacy and safety of the combination of capmatinib with pembrolizumab compared to pembrolizumab alone as first-line treatment for subjects with locally advanced or metastatic NSCLC who have PD-L1 expression ≥ 50% and have no EGFR mutation or ALK rearrangement. Capmatinib has demonstrated immunomodulatory activities when combined with an anti-PD1 antibody in preclinical tumor models irrespective of MET dysregulation. The combination of capmatinib with checkpoint inhibitors has been established to be tolerable and could provide additional clinical benefit to the subjects.

Timeline

Start
2020-01-22
Primary completion
2022-01-14
Completion
2023-02-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Capmatinib Small molecule 400 mg Oral
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous