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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 )

Tracking Information
First Submitted Date  ICMJE June 14, 2021
First Posted Date  ICMJE June 15, 2021
Last Update Posted Date October 6, 2022
Actual Study Start Date  ICMJE August 10, 2022
Estimated Primary Completion Date September 21, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2021)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2021)
  • 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.
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC
Official Title  ICMJE 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)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE Drug: capmatinib
150 mg and 200 mg tablets for oral administration
Other Name: INC280
Study Arms  ICMJE
  • 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
    Intervention: Drug: capmatinib
  • Experimental: Cohort B
    Participants with NSCLC with high level MET amplification will take 400 mg tablet orally twice per day
    Intervention: Drug: capmatinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2021)
38
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 4, 2028
Estimated Primary Completion Date September 21, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04926831
Other Study ID Numbers  ICMJE CINC280AUS12
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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/.

Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novartis Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP