A Phase II, Open-Label, Multicenter Study of Capmatinib in Subjects With MET Exon 14 Skipping Mutation Positive, Advanced, NSCLC With Brain Metastases

This is an interventional treatment trial for Non-small Cell Lung Carcinoma (NSCLC) focused on measuring Non-small cell lung carcinoma, Non-small cell lung cancer, NSCLC, Treatment of lung cancer after first metastasi, Lung cancer, Lung adenocarcinoma, Squamous cell lung carcinoma, Large-cell lung carcinoma, Large-cell lung cancer Read More

Inclusion Criteria:

• Histologically confirmed stage IV (according to Version 8 of the American Joint Committee on Cancer (AJCC)) NSCLC that is EGFR wt, ALK rearrangement negative as assessed by a validated test as part of the participant's standard of care and has MET∆ex14 mutation per Novartis-designated central laboratory or (US only) locally with FoundationOne Companion Diagnostic (F1CDx) .
• Treatment naïve or up to two prior lines of systemic therapy for stage IIIb-IV NSCLC

• Measurable intracranial lesions:

  1. Cohort 1 and Cohort 2 (without leptomeningeal carcinoma): At least 1 measurable intracranial lesion per RANO-BM criteria, documented by a radiologist/neuroradiologist (treated or untreated).
  2. Cohort 2 (with leptomeningeal carcinoma): participants with leptomeningeal carcinoma may not have measurable lesions. In this circumstance, the participant's disease will be considered to have non-target lesions only at baseline and their response based on descriptive clinical criteria by physician assessment.
• Capable of undergoing magnetic resonance imaging (MRI)
• ECOG performance status of 0 or 1

Exclusion Criteria:

• Only for Cohort 1: any neurological symptoms related to brain metastases
• For participants in Cohort 2 with prior brain therapy: Treatment with stereotactic radiosurgery within 14 days prior to the start of study treatment or treatment with WBRT within 14 days prior to the start of study treatment
• Prior treatment with any MET targeting therapy or HGF inhibitor
• Participants with other known druggable molecular alterations (such as ROS1 translocation or BRAF mutation) who might be candidates to alternative targeted therapies as applicable per local regulations and treatment guidelines
• Presence or history of ILD or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention)
• Clinically significant, uncontrolled heart diseases including History of familial long QT syndrome, sudden death or congenital long QT syndrome

Other protocol-defined inclusion/exclusion criteria may apply