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

Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting ID

Study Details

Study Description

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
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.

Study Design

Study Type:
Anticipated Enrollment :
38 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
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)
Anticipated Study Start Date :
Jul 30, 2022
Anticipated Primary Completion Date :
Sep 21, 2023
Anticipated Study Completion Date :
Sep 4, 2028

Arms and Interventions

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 Names:
  • 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 Names:
  • INC280
  • Outcome Measures

    Primary Outcome Measures

    1. Major pathological response (MPR) rate based on local review [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 [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 [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 [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 [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.

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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

    Contacts and Locations


    Site City State Country Postal Code
    1 UCLA Oncology Hematology La Jolla California United States 92037
    2 University of California Davis Cancer Center Sacramento California United States 95817
    3 Dana Farber Cancer Center Boston Massachusetts United States 02215
    4 University of Michigan Health System Ann Arbor Michigan United States 48109-0391
    5 Memorial Sloan Kettering New York New York United States 10017
    6 Irving Pavilion; Diabetes Research Unit New York New York United States 10032-3784
    7 University of Texas MD Anderson Cancer Center Houston Texas United States 77030
    8 Fairfax-Northern Virginia Hematology-Oncology Fairfax Virginia United States 22031

    Sponsors and Collaborators

    • Novartis Pharmaceuticals


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Novartis Pharmaceuticals Identifier:
    Other Study ID Numbers:
    • CINC280AUS12
    First Posted:
    Jun 15, 2021
    Last Update Posted:
    Jun 3, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Keywords provided by Novartis Pharmaceuticals
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 3, 2022