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

• Status: Active, not recruiting
• Trial end date: 2023-01-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• Histologically confirmed and documented locally advanced stage III (not candidates for surgical resection or definitive chemo-radiation) or stage IV (metastatic) NSCLC (per AJCC/IASLC v.8) for treatment in the first-line setting

• Histologically or cytologically confirmed diagnosis of NSCLC that is both EGFR wild type status and ALK- negative rearrangement statu

• Have an archival tumor sample or newly obtained tumor biopsy with high PD-L1 expression (TPS ≥ 50%)

• ECOG performance status score ≤ 1

• Have at least 1 measurable lesion by RECIST 1.1

• Have adequate organ function

Exclusion Criteria:

• Prior treatment with a MET inhibitor or HGF-targeting therapy

• Prior immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)

• Have untreated symptomatic central nervous system (CNS) metastases

• Clinically significant, uncontrolled heart diseases

• Prior palliative radiotherapy for bone lesions ≤ 2 weeks prior to starting study treatment

Other protocol-defined inclusion/exclusion criteria may apply.