Tepotinib + Osimertinib for Non-Small Cell Lung Cancer

Recruiting at 179 trial locations

Overseen By Communication Center

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

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study was to assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

Research Team

Medical Responsible

Principal Investigator

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Eligibility Criteria

This trial is for adults with advanced non-small cell lung cancer (NSCLC) who have an EGFR mutation and MET amplification. They must have only received osimertinib previously, shown resistance to it, and be in good physical condition (ECOG 0 or 1). Patients with a history of certain lung diseases, uncontrolled hypertension, brain metastasis requiring steroids, or inadequate organ function cannot participate.

Inclusion Criteria

My cancer progressed after initially responding to osimertinib treatment.

My lung cancer has a specific EGFR mutation.

My cancer has MET amplification confirmed by specific tests.

Exclusion Criteria

I have had lung conditions that needed steroid treatment.

My high blood pressure is not controlled, even with medication.

Other protocol defined exclusion criteria could apply

Treatment Details

Interventions

• Osimertinib (EGFR inhibitor)
• Tepotinib (MET inhibitor)

Trial Overview The study tests the combination of two drugs: Tepotinib (a MET inhibitor) and Osimertinib (an EGFR inhibitor), in patients whose NSCLC has worsened after treatment with Osimertinib alone. It aims to evaluate the effectiveness and safety profile of this drug combo.

Participant Groups

Group I: Tepotinib and Osimertinib Experimental Treatment 2 Interventions

Participants received a single oral dose of Tepotinib 500 milligrams (mg) followed by Omisertinib 80 mg once daily until disease progression, death, adverse event leading to discontinuation, study withdrawal or consent withdrawal.

Group II: Tepotinib Mono-therapy Experimental Treatment 1 Intervention

Participants received a single oral dose of Tepotinib 500 mg until disease progression, death, adverse event leading to discontinuation, study withdrawal or consent withdrawal.

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