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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)
May have definitively, locally treated brain metastases that are clinically stable and asymptomatic for greater than (>) 2 weeks and who are off or receiving low-dose corticosteroid treatment (less than or equal to [<=]10 milligrams (mg) prednisone or equivalent) for at least 2 weeks prior to start of study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years 1 month
Awards & highlights
No Placebo-Only Group

METalmark Trial 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.

METalmark Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Stage IV non-small cell lung cancer that cannot be surgically removed.
Select...
My brain metastases have been treated, are stable, and I've had no symptoms for over 2 weeks.
Select...
I have had cancer before, but it won't affect this study's treatment.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

METalmark Trial 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

METalmark 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
~200
Amivantamab
2021
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
973 Previous Clinical Trials
6,383,604 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,717 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 2 (Dose Expansion), Phase 1 (Combination Dose Selection)
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

Frequently Asked Questions

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

In how many different places can people participate in this clinical trial?

"There are 13 hospitals conducting this trial, such as VCU Medical Center in Richmond, University of Alabama at Birmingham, Comprehensive Cancer Center in Birmingham and Providence Portland Medical Center in Portland."

Answered by AI

Does Amivantamab have the FDA's backing?

"Amivantamab was given a score of 2 by our analysts because, although there is evidence that the drug is safe, there is no data demonstrating that it is effective."

Answered by AI

Are we still receiving participants for this experiment?

"The clinical trial mentioned is not presently enrolling patients, as noted on clinicaltrials.gov. This study was posted on November 28th, 2020 and updated recently on the 9th of November, 2020. Although this specific study isn't recruiting at this time, there are 1,394 other trials that are still recruiting patients."

Answered by AI

What are the goals that researchers hope to achieve with this trial?

"The primary outcome of this study, which will be evaluated over about Up to 2 years 1 month is to Phase 1: Number of Participants with Adverse events (AEs) by Severity. Secondary objectives include Phase 2: Overall Survival (OS) which is defined as OS is defined as the time from the date of administration of the first study treatment until the date of death due to any cause., Phase 1: Number of Participants with Abnormalities in Clinical Laboratory Parameters which is defined as Number of participants with abnormalities in clinical laboratory parameters (serum chemistry, hematology, coagulation, serology, and urinalysis)"

Answered by AI
~60 spots leftby Dec 2024