Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Non-small Cell Lung Cancer
Age (in years)
18 - 90
Phase
Phase 2
Participants needed
3
Est. Completion Date
Aug 6, 2026
Treatment type
Interventional
Sponsor
Novartis
ClinicalTrials.gov identifier
NCT04926831
Study number
CINC280AUS12
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