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Capmatinib for Non-Small Cell Lung Cancer (Geometry-N Trial)

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of surgery and at 24, 36, and 60 months
Awards & highlights

Geometry-N Trial Summary

This trial will test if adding the drug capmatinib to surgery, chemotherapy, and radiation can improve outcomes for people with early- to mid-stage non-small cell lung cancer that has MET mutations or high MET amplification.

Who is the study for?
This trial is for adults with early-stage Non-Small Cell Lung Cancer (NSCLC) stages IB-IIIA, specifically those with MET exon 14 mutations or high MET amplification. Candidates must be eligible for surgery and have no brain metastasis, prior cancer treatments within 3 years, lung conditions like pneumonitis, previous treatment with MET inhibitors, or major surgeries within the last month.Check my eligibility
What is being tested?
The study tests if capmatinib can improve patient outcomes when given before (neoadjuvant) and after (adjuvant) standard treatments such as surgery, chemotherapy, and radiation in NSCLC patients who are positive for certain genetic changes related to their cancer.See study design
What are the potential side effects?
Capmatinib may cause side effects including nausea, vomiting, increased liver enzymes which could indicate liver damage; swelling due to fluid retention; fatigue; difficulty breathing; and potential harm to an unborn baby if taken during pregnancy.

Geometry-N Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung cancer is at a specific stage and has been confirmed by a tissue test.
Select...
My cancer has MET exon 14 mutations or high MET amplification.

Geometry-N Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of surgery and at 24, 36, and 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of surgery and at 24, 36, and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Major pathological response (MPR) rate based on local review
Secondary outcome measures
Complete pathologic response (pCR) rate based on central and local review
Disease free survival rate (DFS) from start of adjuvant therapy
Number of adverse events and serious adverse events as assessed by CTCAE criteria
+1 more

Geometry-N Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort BExperimental Treatment1 Intervention
Participants with NSCLC with high level MET amplification will take 400 mg tablet orally twice per day
Group II: Cohort AExperimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,346 Total Patients Enrolled

Media Library

capmatinib Clinical Trial Eligibility Overview. Trial Name: NCT04926831 — Phase 2
Non-Small Cell Lung Cancer Clinical Trial 2023: capmatinib Highlights & Side Effects. Trial Name: NCT04926831 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently participating in this investigation?

"This medical trial needs 38 volunteers that meet the eligibility requirements. UCLA Oncology Hematology in La Jolla and Dana Farber Cancer Center in Boston are two of several available locations for participation."

Answered by AI

Has capmatinib been officially endorsed by the FDA?

"Capmatinib has been assigned a score of 2 as it is currently undergoing Phase 2 trials, which have provided some assurance that the drug is safe but no data to prove its efficacy."

Answered by AI

How many health care facilities are participating in this experiment?

"There are 8 participating sites in this trial, e.g., UCLA Oncology Hematology in La Jolla, Dana Farber Cancer Center in Boston, and University of Michigan Health System in Ann Arbor. Additionally there are 5 other establishments contributing to the study."

Answered by AI

What other exploratory data has been gathered regarding capmatinib?

"Research into capmatinib has been ongoing since 2013, with 13 completed clinical trials and 15 more currently underway. Much of the current research is taking place at a Novartis Investigative Site in La Jolla, California."

Answered by AI

Is recruitment for this trial currently open?

"The information hosted on clinicaltrials.gov shows that this trial is currently in the process of recruiting patients. This clinical experiment was first launched on August 10th 2022 and has seen its most recent update occur on October 5th 2022."

Answered by AI

Are individuals under the age of thirty-five considered viable candidates for this experiment?

"This clinical trial is available for individuals aged between 18 and 90. Alternatively, there are 23 trials specifically targeting minors and 1428 studies with a primary focus on those 65 years old or above."

Answered by AI

Is this the inaugural investigation of its kind?

"Researching capmatinib has been underway since 2013, when Novartis Pharmaceuticals ran the first study with 38 participants. This was followed by Phase 2 drug approval and now there are 15 active experiments involving this medication across 130 cities in 39 nations."

Answered by AI

Do I meet the qualifications to join this research trial?

"This trial is open to 38 individuals diagnosed with non-small cell lung cancer who are between 18 and 90 years of age. To qualify, prospective participants must either possess MET exon 14 mutations or display high level MET amplification, in addition to being eligible for surgery within two weeks after the final dose of preoperative study medication."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC
2022. "Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04926831.
~2 spots leftby Aug 2026
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