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Monoclonal Antibodies

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

Phase 1 & 2

Waitlist Available

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

No Placebo-Only Group

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).

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years 1 month

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met