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Monoclonal Antibodies
Amivantamab + Tepotinib for Lung Cancer
Phase 1 & 2
Recruiting
Led By Xiuning Le, MD,PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed non-small cell lung cancer.
Locally advanced or metastatic disease, not amenable to curative surgery or radiotherapy.
Must not have
For cohort A (METex14 TKI-naïve only), prior targeted therapy to c-MET is not allowed, which includes small molecule TKIs, such as tepotinib, capmatinib, savolitinib, or crizotinib. Prior amivantamab is also not allowed.
Participant has an active or past medical history of ILD/pneumonitis, including drug-induced or radiation ILD/pneumonitis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial studies if a drug combo can help with lung cancer and if it's safe.
Who is the study for?
Adults with non-small cell lung cancer (NSCLC) that has specific genetic changes called MET alterations. They must have measurable disease, be able to take oral medication, and agree to use contraception. People who've had certain treatments or have other health issues like uncontrolled illnesses, active infections, or a history of severe lung inflammation are not eligible.
What is being tested?
The trial is testing the effectiveness and safety of combining two drugs: Amivantamab and Tepotinib in treating NSCLC with MET alterations. It aims to see if this drug combo can control the cancer better than current treatments.
What are the potential side effects?
Possible side effects include reactions at the infusion site for amivantamab, liver enzyme changes from tepotinib, fatigue, skin rash, nausea. Each person's experience may vary and some side effects could be serious.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer has been confirmed by lab tests.
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My cancer has spread and cannot be cured with surgery or radiation.
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My cancer has a specific genetic change known as MET gene amplification.
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I am fully active or can carry out light work.
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My NSCLC has a specific genetic change known as MET Exon 14 skipping.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not taken any MET inhibitor drugs like tepotinib or crizotinib for my condition.
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I have or had lung inflammation due to illness or treatment.
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I still have a rash from previous cancer treatment.
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My cancer does not have mutations like EGFR, KRASG12C, or ALK, or I haven't been treated with targeted therapies like osimertinib.
Select...
I do not have any uncontrolled illnesses or need for continuous oxygen.
Select...
I have a long-term liver condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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: Amivantamab and Tepotinib CombinationExperimental Treatment2 Interventions
Participants will be given 2 investigational drugs (amivantamab and tepotinib) and come to the clinic for study visits every 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tepotinib
2018
Completed Phase 2
~360
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,485 Total Patients Enrolled
Xiuning Le, MD,PHDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
56 Total Patients Enrolled