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

Protocol # :
Non-Small Cell Lung Cancer
Disease Sites
Principal Investigator
Rochefort, Matthew
Site Research Nurses
Mcnally, Megan
Sullivan, Molly, O'Brien

Trial Description

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.

Eligibility Requirements

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

- 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