Capmatinib for Non-Small Cell Lung Cancer
(Geometry-N Trial)

Recruiting in Palo Alto (17 mi)

+13 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Novartis Pharmaceuticals

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study was planned to determine if neoadjuvant capmatinib could improve the major pathological response (MPR) in patients with Stage IB-IIIA, N2 and selected IIIB (T3N2 or T4N2) lung cancers with Mesenchymal Epithelial Transition (MET) exon 14 mutations and/or high MET amplification beyond those achieved with surgery, chemotherapy, and radiation. Treatment was to be continued with capmatinib in the adjuvant setting to evaluate the potential clinical benefit of extended therapy. 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.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for adults with early-stage Non-Small Cell Lung Cancer (NSCLC) stages IB-IIIA, specifically those with MET exon 14 mutations or high MET amplification. Candidates must be eligible for surgery and have no brain metastasis, prior cancer treatments within 3 years, lung conditions like pneumonitis, previous treatment with MET inhibitors, or major surgeries within the last month.

Inclusion Criteria

My lung cancer is at a specific stage and has been confirmed by a tissue test.

My cancer has MET exon 14 mutations or high MET amplification.

I am scheduled for surgery within 2 weeks after my last pre-surgery treatment.

Exclusion Criteria

I have or had lung inflammation or scarring.

My cancer cannot be removed by surgery and I've had brain scans to check for cancer spread.

I haven't had cancer treatments like chemotherapy for my lung cancer in the last 3 years.

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Treatment Details

Interventions

Capmatinib (Small Molecule Inhibitor)

Trial OverviewThe study tests if capmatinib can improve patient outcomes when given before (neoadjuvant) and after (adjuvant) standard treatments such as surgery, chemotherapy, and radiation in NSCLC patients who are positive for certain genetic changes related to their cancer.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Cohort B (high MET amplification)Experimental Treatment1 Intervention

The study treatment started on Cycle 1 Day 1 with the first administration of capmatinib 400 mg twice a day (b.i.d.). The participants were planned to receive study treatment for a maximum of 3 years following surgery or until early discontinuation.

Group II: Cohort A (MET exon 14 skipping mutations)Experimental Treatment1 Intervention