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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 42 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 42 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 42 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 42 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Combined Modality Therapy

Safety run-in: 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)

Secondary outcome measures

Apparent Total Body Clearance (CL/f) of Tepotinib and Osimertinib and Their Metabolities

Apparent Volume Of Distribution (Vz/F) of Tepotinib and Osimertinib and Their Metabolities

Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of Tepotinib and Osimertinib and Their Metabolities

+22 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Tepotinib and OsimertinibExperimental Treatment2 Interventions

Participants will receive a combination of tepotinib and osimertinib. The combination will be applied in cycles of 21 days until disease progression, death, adverse event leading to discontinuation, study withdrawal or consent withdrawal.

Group II: Tepotinib Mono-therapyExperimental Treatment1 Intervention

Participants will receive once daily dose of tepotinib. The mono therapy will be applied in cycles of 21 days 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

~1010

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck KGaA, Darmstadt, GermanyIndustry Sponsor

436 Previous Clinical Trials

114,536 Total Patients Enrolled

EMD Serono Research & Development Institute, Inc.Lead Sponsor

76 Previous Clinical Trials

30,740 Total Patients Enrolled

Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

288 Previous Clinical Trials

68,855 Total Patients Enrolled

Media Library

Osimertinib (EGFR inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03940703 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Tepotinib Mono-therapy, Tepotinib and Osimertinib

Non-Small Cell Lung Cancer Clinical Trial 2023: Osimertinib Highlights & Side Effects. Trial Name: NCT03940703 — Phase 2

Osimertinib (EGFR inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03940703 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What kind of hazards can be associated with Osimertinib treatment?

"Osimertinib's safety was assessed at 2, as the Phase 2 trial has produced evidence of its security but not yet proven efficacy."

Answered by AI

Is enrollment for this research endeavor still open to participants?

"According to the information posted on clinicaltrials.gov, this trial is still ongoing and recruiting participants. It was initially made available in September 2019 with updates as recent as October 6th 2022."

Answered by AI

What other investigations have been conducted with respect to the potential of Osimertinib?

"Currently, there are 104 studies related to Osimertinib in operation. 17 of these investigations qualify as Phase 3 trials. Primarily based out of Uniondale, New york, the total number of sites distributing this medication is 4874."

Answered by AI

Is this an unprecedented research endeavor?

"Osimertinib was first studied in 2013, under the sponsorship of AstraZeneca. After Phase 1 and 2 drug approval gained from its initial trial with 603 participants, there are now 104 active trials recruiting patients across 1062 urban centres globally, spanning 51 countries."

Answered by AI

Recent research and studies

metJournal

INSIGHT 2: A Phase II Study of Tepotinib Plus Osimertinib in <i>met</i>-amplified NSCLC and First-line Osimertinib Resistance

F Smit, Egbert, Christophe Dooms, Jo Raskin, Ernest Nadal, Lye M Tho, Xiuning Le, Julien Mazieres, et al.. 2022. “INSIGHT 2: A Phase II Study of Tepotinib Plus Osimertinib in met-amplified NSCLC and First-line Osimertinib Resistance”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2021-1406.

metJournal

INSIGHT 2: A Phase II Study of Tepotinib Plus Osimertinib in <i>met</i>-amplified NSCLC and First-line Osimertinib Resistance

clinicaltrials.govStudy

A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)

2019. "A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03940703.