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EGFR inhibitor

Tepotinib + Osimertinib for Non-Small Cell Lung Cancer

Phase 2

Waitlist Available

Research Sponsored by EMD Serono Research & Development Institute, Inc.

Eligibility Criteria Checklist

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

Must have

Acquired resistance on previous first-line osimertinib with radiological documentation of disease progression and objective clinical benefit documented during previous osimertinib therapy

Locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) histology with documented activating Epidermal Growth Factor Receptor (EGFR) mutation

Must not have

History of interstitial lung disease(ILD) or interstitial pneumonitis including radiation pneumonitis that required steroid treatment

Hypertension uncontrolled by standard therapies (not stabilized to < 150/90 millimeter of mercury (mmHg)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, safety follow-up (up to 42 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of a new cancer drug combination on lung cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include issues affecting lungs like interstitial lung disease, problems related to liver and kidney function, heart complications, high blood pressure not controlled by medication, as well as general chemotherapy-related side effects.

Eligibility Criteria

Inclusion Criteria

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

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My cancer progressed after initially responding to osimertinib treatment.

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My lung cancer has a specific EGFR mutation.

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My cancer has MET amplification confirmed by specific tests.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had lung conditions that needed steroid treatment.

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

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

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

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I cannot take osimertinib due to health reasons.

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My heart does not function properly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, safety follow-up (up to 42 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, safety follow-up (up to 42 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, safety follow-up (up to 42 months) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Combined Therapy (Tepotinib+Osimertinib): Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version (NCI-CTCAE v 5.0)

Combined Therapy: Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1as Per Independent Review Committee in Participants With MET Amplification Determined Centrally by Fluorescence in Situ Hybridization(FISH)

Secondary study objectives

Combined Therapy ((Tepotinib + Osimertinib): Progression-Free Survival (PFS) According to RECIST Version1.1 as Assessed by the Investigator in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing

Combined Therapy (Tepotinib + Osimertinib): Apparent Total Body Clearance (CL/f) of Tepotinib and Its Metabolites (MSC2571109A, MSC2571107A), Osimertinib and Its Metabolite AZD5104

Combined Therapy (Tepotinib + Osimertinib): Apparent Volume Of Distribution (Vz/F) of of Tepotinib and Its Metabolites (MSC2571109A, MSC2571107A), Osimertinib and Its Metabolite AZD5104

+42 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tepotinib

2018

Completed Phase 2

~360

Osimertinib

2017

Completed Phase 4

~1120