We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC (Geometry-N)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04926831
Recruitment Status : Recruiting
First Posted : June 15, 2021
Last Update Posted : October 6, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: capmatinib Phase 2

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : August 10, 2022
Estimated Primary Completion Date : September 21, 2023
Estimated Study Completion Date : September 4, 2028

Resource links provided by the National Library of Medicine

Drug Information available for: Capmatinib

Arm Intervention/treatment
Experimental: Cohort A
Participants with NSCLC with MET exon 14 skipping mutations, irrespective of MET gene copy number (GCN) will take 400 mg tablet orally twice per day
Drug: capmatinib
150 mg and 200 mg tablets for oral administration
Other Name: INC280

Experimental: Cohort B
Participants with NSCLC with high level MET amplification will take 400 mg tablet orally twice per day
Drug: capmatinib
150 mg and 200 mg tablets for oral administration
Other Name: INC280




Primary Outcome Measures :
  1. Major pathological response (MPR) rate based on local review [ Time Frame: Baseline up to time of surgery (approximately 8 to 10 weeks after first dose) ]
    MPR rate in each cohort defined as the percentage of participants with ≤ 10% residual viable cancer cells


Secondary Outcome Measures :
  1. Complete pathologic response (pCR) rate based on central and local review [ Time Frame: Baseline up to time of surgery (approximately. 8- 10 weeks after first dose) ]
    Complete pathologic response (pCR) rate is defined as the percentage of participants with no residual viable cancer cells.

  2. Overall response rate (ORR) based on local investigator assessment [ Time Frame: Baseline up to time of surgery (approximately 8 - 10 weeks after first dose) ]
    Overall response rate (ORR) is defined as the percentage participants with best overall response (BOR) of complete response (CR) or partial response ( PR) according to RECIST v1.1

  3. Number of adverse events and serious adverse events as assessed by CTCAE criteria [ Time Frame: Baseline up to approximately 40 months ]

    The occurrence of adverse events will be reported from first day of treatment through end of treatment plus 30 days.

    Serious adverse events which are treatment related will be reported through the end of study participation. Adverse events also may be detected or through physical examination findings, laboratory test findings, or other assessments.


  4. Disease free survival rate (DFS) from start of adjuvant therapy [ Time Frame: From time of surgery and at 24, 36, and 60 months ]
    Defined as the time from end of surgery (start of adjuvant therapy) until the recurrence of cancer or death due to any cause.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04926831


Contacts
Layout table for location contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
Layout table for location information
United States, California
UCLA Oncology Hematology Recruiting
La Jolla, California, United States, 92037
Principal Investigator: Amy Cummings         
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Principal Investigator: Li Tianhong         
United States, Massachusetts
Dana Farber Cancer Center Recruiting
Boston, Massachusetts, United States, 02215
Contact    617-643-1820      
Principal Investigator: Rochefort Matthew         
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109-0391
Contact    734-763-0470      
Principal Investigator: Jules Lin         
United States, New York
Memorial Sloan Kettering Recruiting
New York, New York, United States, 10017
Contact    212-639-2000      
Principal Investigator: Jamie Chaft         
Irving Pavilion; Diabetes Research Unit Recruiting
New York, New York, United States, 10032-3784
Contact    212-305-8797      
Principal Investigator: Shu Catherine         
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact    713-792-2921      
Principal Investigator: Xiuning Le         
United States, Virginia
Fairfax-Northern Virginia Hematology-Oncology Recruiting
Fairfax, Virginia, United States, 22031
Principal Investigator: Alexander Spira         
Sponsors and Collaborators
Novartis Pharmaceuticals
Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04926831    
Other Study ID Numbers: CINC280AUS12
First Posted: June 15, 2021    Key Record Dates
Last Update Posted: October 6, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
MET exon 14 skipping mutation
High MET amplification
Neoadjuvant
Prior to surgery
Adjuvant
After surgery
INC280
MET inhibition
adult
capmatinib
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases