Lung Cancer Clinical Trial

Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC

Summary

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.

View Full Description

Full Description

This trial is a phase II, two cohort study of neoadjuvant capmatinib treatment (pre-surgery) which will be given for 8 weeks prior to a surgical resection and then followed by a three year adjuvant capmatinib treatment (post surgery). Following treatment, there will be a two year survival follow-up. The two molecularly defined cohorts will be enrolled in parallel. Approximately 38 evaluable participants will be enrolled in the study.

During treatment participants will visit their treating physician to assess overall health status which will include lab-work and other safety assessments. Survival follow-up will be every 6 months which can be conducted via a telephone visit for up to approximately 2 years after end of treatment.

View Eligibility Criteria

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 is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

38

Study ID:

NCT04926831

Recruitment Status:

Recruiting

Sponsor:

Novartis Pharmaceuticals

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 8 Locations for this study

See Locations Near You

UCLA Oncology Hematology
La Jolla California, 92037, United States More Info
Amy Cummings
Principal Investigator
University of California Davis Cancer Center
Sacramento California, 95817, United States More Info
Li Tianhong
Principal Investigator
Dana Farber Cancer Center
Boston Massachusetts, 02215, United States More Info
Contact
617-643-1820
Rochefort Matthew
Principal Investigator
University of Michigan Health System
Ann Arbor Michigan, 48109, United States More Info
Contact
734-763-0470
Jules Lin
Principal Investigator
Memorial Sloan Kettering
New York New York, 10017, United States More Info
Contact
212-639-2000
Jamie Chaft
Principal Investigator
Irving Pavilion; Diabetes Research Unit
New York New York, 10032, United States More Info
Contact
212-305-8797
Shu Catherine
Principal Investigator
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Contact
713-792-2921
Xiuning Le
Principal Investigator
Fairfax-Northern Virginia Hematology-Oncology
Fairfax Virginia, 22031, United States More Info
Alexander Spira
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

38

Study ID:

NCT04926831

Recruitment Status:

Recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.