Tepotinib for Lung Cancer

Recruiting at 156 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: EMD Serono Research & Development Institute, Inc.

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study looked at how effective the study drug (tepotinib) was at stopping the growth and spread of lung cancer. This study also measures a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life. The study also has an optional pharmacogenetic research part. Pharmacogenetic research is an important way to try to understand the role of genetics in human disease and how genes impact the effectiveness of drugs, because differences in genes can change the way a person responds to a particular drug.

Research Team

Medical Responsible

Principal Investigator

EMD Serono Research & Development Institute, Inc, a business of Merck KGaA, Darmstadt, Germany

Eligibility Criteria

This trial is for adults with advanced non-small cell lung cancer (NSCLC) that haven't had more than two prior treatments. They must have a certain gene alteration called METex14 and be in good physical condition (ECOG PS of 0 or 1). Women participating should not be pregnant or breastfeeding and must use effective contraception, as should men with female partners who could bear children.

Inclusion Criteria

I agree to use, and ensure my partner uses, effective birth control.

My lung cancer is advanced and has been confirmed by lab tests.

I am not pregnant or breastfeeding and either cannot become pregnant or agree to use effective birth control.

Exclusion Criteria

You have a current drug or alcohol problem, ongoing infection, or other serious health or mental issues that could make it risky for you to take part in the trial, as decided by the doctors in charge.

I am legally unable to make my own decisions.

Participation in another clinical trial within the past 30 days

Treatment Details

Interventions

• Tepotinib (Kinase Inhibitor)

Trial Overview The study tests the effectiveness of tepotinib, a drug aimed at stopping lung cancer growth and spread. It also examines how the body processes this drug, its safety profile, side effects, impact on quality of life, and includes optional genetic research to understand how genes affect drug response.

Participant Groups

Group I: Part 2: Cohort C: Confirmatory Part for METex14 Skipping Alterations Experimental Treatment 1 Intervention

Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.

Group II: Part 1: Cohort B: MET Amplification Experimental Treatment 1 Intervention

Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.

Group III: Part 1: Cohort A: METex14 Skipping Alterations Experimental Treatment 1 Intervention

Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.

Tepotinib is already approved in Japan for the following indications:

Approved in Japan as Tepmetko for:

• Non-small cell lung cancer (NSCLC) with MET alterations

Who Is Running the Clinical Trial?

EMD Serono Research & Development Institute, Inc.

Lead Sponsor

Trials

86

Recruited

22,700+

Miguel Fernández Alcalde

EMD Serono Research & Development Institute, Inc.

Chief Executive Officer

Bachelor’s Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master’s Degree in Management from IESE Business School

Danny Bar-Zohar

EMD Serono Research & Development Institute, Inc.

Chief Medical Officer since 2022

MD

Merck KGaA, Darmstadt, Germany

Industry Sponsor

Trials

449

Recruited

122,000+

Danny Bar-Zohar

Merck KGaA, Darmstadt, Germany

Chief Medical Officer since 2022

MD

Belén Garijo

Merck KGaA, Darmstadt, Germany

Chief Executive Officer since 2021

MD