Tepotinib + Osimertinib for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+179 other 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

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).

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.

I have only been treated with osimertinib for my advanced lung cancer.

I can care for myself and doctors expect me to live at least 12 more weeks.

Exclusion Criteria

I have had lung conditions that needed steroid treatment.

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

I don't have any lasting side effects from cancer treatment, except for hair loss.

My blood, liver, and kidney functions are not within normal ranges.

I cannot take osimertinib due to health reasons.

My heart does not function properly.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: Tepotinib and OsimertinibExperimental Treatment2 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-therapyExperimental Treatment1 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.

Osimertinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tagrisso for:

Locally advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations
Metastatic EGFR T790M mutation-positive NSCLC

🇪🇺 Approved in European Union as Tagrisso for:

Locally advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations
Metastatic EGFR T790M mutation-positive NSCLC