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Monoclonal Antibodies

Amivantamab + Capmatinib for Non-Small Cell Lung Cancer (METalmark Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previously diagnosed with histologically or cytologically confirmed unresectable Stage IV (metastatic) non-small cell lung cancer (NSCLC) (any histology)
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Must not have
Participant has impairment of the gastrointestinal function that could affect absorption of capmatinib or is unable or unwilling to swallow tablets
Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years 1 month
Awards & highlights

Summary

This trial is testing a combination of two drugs to treat non-small cell lung cancer. The first part of the trial is to find the best dose of the combination, and the second part is to see how well the combination works.

Who is the study for?
This trial is for adults with Stage IV non-small cell lung cancer that can't be surgically removed. They should have stable brain metastases, no history of certain lung diseases or gastrointestinal issues affecting drug absorption, and controlled tumor-related pain. Participants must not need high doses of steroids and should be in good physical condition (ECOG 0 or 1).Check my eligibility
What is being tested?
The study tests a combination therapy using Amivantamab and Capmatinib to treat NSCLC patients with specific genetic changes (MET exon 14 skipping mutation or MET amplification). It aims to find the best dose for Phase 2 trials and assess how well tumors respond to this treatment.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, changes in liver function tests, fatigue, nausea, swelling due to fluid retention, skin rash, shortness of breath due to inflammation in the lungs (pneumonitis), and other symptoms related to immune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Stage IV non-small cell lung cancer that cannot be surgically removed.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take pills due to issues with my stomach or intestines.
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I have or might have a lung condition not caused by an infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years 1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Number of Participants with Adverse events (AEs) by Severity
Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs)
Phase 2: Objective Response Rate
Secondary outcome measures
Phase 1: Number of Participants with AEs by Severity
Phase 1: Number of Participants with Abnormalities in Clinical Laboratory Parameters
Phase 2 (Cohort 1A): Change from Baseline in Health-related Quality of Life in (HRQoL) as Assessed by European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2 (Dose Expansion)Experimental Treatment2 Interventions
Participants with mesenchymal-epithelial transition (MET) exon 14 skipping mutation who are treatment naïve (Cohort 1A), who have received prior therapy (Cohort 1B), or participants with MET amplification who have received prior therapy (Cohort 1C) will receive capmatinib in combination with amivantamab at the RP2CD determined by the SET in Phase 1.
Group II: Phase 1 (Combination Dose Selection)Experimental Treatment2 Interventions
Participants will receive capmatinib 400 milligrams (mg) orally twice daily from Cycle 1 Day 1, in combination with amivantamab 700 mg intravenous (IV) infusion (for body weight less than 80 kilograms [kg]) or 1050 mg IV infusion (for body weight greater than or equal to 80 kg) once weekly from Cycle 1 Day 1 for 4 weeks and then every 2 weeks from Week 5 (Cycle 2; each cycle of 28 days). Doses will be escalated or de-escalated based on the dose limiting toxicities (DLTs) and the recommended Phase 2 combination dose (RP2CD) will be determined by the study evaluation team (SET).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capmatinib
2021
Completed Phase 3
~570

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
980 Previous Clinical Trials
6,384,132 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
749 Previous Clinical Trials
3,960,786 Total Patients Enrolled

Media Library

Amivantamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05488314 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Phase 1 (Combination Dose Selection), Phase 2 (Dose Expansion)
Non-Small Cell Lung Cancer Clinical Trial 2023: Amivantamab Highlights & Side Effects. Trial Name: NCT05488314 — Phase 1 & 2
Amivantamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05488314 — Phase 1 & 2
~27 spots leftby Dec 2024
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