Phase II trial of neoadjuvant and adjuvant capmatinib in participants with stages IB-IIIA, N2 and selected IIIB (T3N2 or T4N2) NSCLC with MET exon 14 skipping mutation or high MET amplification – Geometry-N
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.
- 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.
- 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
- 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