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Monoclonal Antibodies

Amivantamab for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Led By Christian D Rolfo

Research Sponsored by SWOG Cancer Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have progressed following the most recent line of therapy

Participants must not have a prior or concurrent malignancy that may interfere with the safety or efficacy assessment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a drug called amivantamab-vmjw in patients with a specific type of lung cancer that has extra copies of the MET gene. The drug aims to reduce the extra

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer that has extra copies of the MET gene. They must have measurable disease, no other actionable cancer mutations, and should have tried at least one systemic treatment before. Participants need a recent CT or MRI scan and stable brain metastases if present.

What is being tested?

The trial tests amivantamab-vmjw's effectiveness in treating lung cancer with MET amplification. It involves imaging tests like MRI and CT scans to monitor the disease, as well as collecting biospecimens to understand how the drug works.

What are the potential side effects?

Possible side effects of amivantamab include infusion reactions (like fever or chills), skin rash, muscle pain, nausea, fatigue, shortness of breath, and swelling due to fluid retention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition worsened after my last treatment.

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I do not have any other cancer that could affect this treatment's safety or results.

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My current physical health allows me to perform daily activities.

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I do not have high blood pressure that requires treatment.

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I do not have any current infections.

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I do not have any current bleeding disorders.

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My disease can be measured on scans taken recently.

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I do not need constant oxygen support.

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My cancer does not have any known treatable gene changes.

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I have had at least one treatment for stage IV or recurrent non-small cell lung cancer.

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I have never been treated with MET tyrosine kinase inhibitors for any cancer.

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My NSCLC has MET amplification confirmed by a specific tissue test.

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I am not planning to receive any other cancer treatments like chemotherapy or immunotherapy.

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I do not have any active liver infections.

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I do not have any eye conditions.

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I do not have any specific lung conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Response rate for amivantamab-vmjw

Secondary study objectives

Duration of response

Incidence of adverse events

Overall survival

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (amivantamab)Experimental Treatment4 Interventions

Patients receive amivantamab IV on days 1 and 2 in week and once a week in weeks 2-4 of cycle 1 and then on days 1 and 15 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and collection of blood samples throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180

Computed Tomography

2017

Completed Phase 2

~2790