Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC

• Status: Recruiting
• Trial end date: 2028-09-04
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if neoadjuvant capmatinib can improve outcomes in participants with stages I-IIIA non-small cell lung cancer with MET exon 14 mutations and/or high MET amplification beyond those achieved with surgery, chemotherapy, and radiation.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Histologically confirmed NSCLC stage IB-IIIA, N2 and selected IIIB (T3N2 or T4N2)

• Participant must have either MET exon 14 mutations and/or high level MET amplification

• Participants must be eligible for surgery and scheduled for surgical resection within approximately 2 weeks after the last does of neoadjuvant study treatment.

Exclusion Criteria:

• Participants with unresectable or metastatic disease. All participants should have brain imaging (either MRI brain or CT brain with contrast) prior to enrollment to exclude brain metastasis.

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

• Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within 4 weeks prior to starting study treatment, or who have not recovered from side effects of such procedure.

• Prior systemic anti-cancer therapy (chemotherapy, immunotherapy, biologic therapy, vaccine) or investigational agents for NSCLC within the past 3 years.

• History of or current interstitial lung disease or pneumonitis

Other protocol-defined inclusion/exclusion criteria may apply at the end