Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC

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)

ClinicalTrials.gov Identifier: NCT04926831

Novartis Reference Number: CINC280AUS12

Last Update: Apr 15, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study 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.

Condition 
Non-small Cell Lung Cancer
Phase 
Phase 2
Overall status 
Recruiting
Start date 
May 31, 2022
Completion date 
Sep 04, 2028
Gender 
All
Age(s)
18 Years - 90 Years (Adult, Older Adult)

Interventions

Drug
capmatinib
150 mg and 200 mg tablets for oral administration

Eligibility 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:

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

United States
UCLA Oncology Hematology
Recruiting
La Jolla, 92037 - California
Contact: Amy Cummings
United States
University of California Davis Cancer Center
Recruiting
Sacramento, 95817 - California
Contact: Li Tianhong
United States
Dana Farber Cancer Center
Recruiting
Boston, 02215 - Massachusetts
Contact: (617-643-1820) Rochefort Matthew
United States
University of Michigan Health System
Recruiting
Ann Arbor, 48109-0391 - Michigan
Contact: (734-763-0470) Jules Lin
United States
Irving Pavilion; Diabetes Research Unit
Recruiting
New York, 10032-3784 - New York
Contact: (212-305-8797) Shu Catherine
United States
University of Texas MD Anderson Cancer Center
Recruiting
Houston, 77030 - Texas
Contact: (713-792-2921) Xiuning Le
United States
Fairfax-Northern Virginia Hematology-Oncology
Recruiting
Fairfax, 22031 - Virginia
Contact: Alexander Spira
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]