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

Official Title

A Randomized, Open Label, Multicenter Phase II Study Evaluating the Efficacy and Safety of Capmatinib (INC280) Plus Pembrolizumab Versus Pembrolizumab Alone as First Line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer With PD-L1≥ 50%

Summary:

The purpose is 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.

Trial Description

Primary Outcome Measures  :

• Progression-free survival (PFS) based on local investigator assessment as per RECIST 1.1

Secondary Outcome Measures  :

• Objective response rate (ORR) based on local investigator assessment as per RECIST 1.1
• Disease control rate (DCR) based on local investigator assessment as per RECIST 1.1
• Time-to-response (TTR) based on local investigator assessment as per RECIST 1.1
• Duration of response (DOR) based on local investigator assessment as per RECIST 1.1
• Overall survival (OS)
• Antidrug antibodies (ADA) of pembrolizumab
• AUC of Capmatinib derived from plasma capmatinib concentration
• Ctrough of Pembrolizumab derived from serum pembrolizumab concentration
• Cmax of Capmatinib derived from plasma capmatinib concentration
• Tmax of Capmatinib derived from plasma capmatinib concentration

View this trial on ClinicalTrials.gov