Recruiting

COMETTepotinib for MET Exon 14 Mutated NSCLC

What is being tested

Tepotinib

+ Pemetrexed (Alimta)

+ Vinorelbine

Drug

Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years

+24 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: December 2025

See protocol details

Summary

Principal SponsorIntergroupe Francophone de Cancerologie Thoracique

Study ContactContact IFCT

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 9, 2025

Actual date on which the first participant was enrolled.

This clinical trial is designed to compare the effectiveness of a drug called tepotinib with standard treatments for patients with a specific type of advanced lung cancer known as MET exon 14 mutated non-small cell lung cancer (NSCLC). This type of lung cancer often affects older and more fragile individuals who have limited treatment options. The study aims to demonstrate that tepotinib can offer better results than current treatments, such as improving the time patients live without the disease getting worse and enhancing their quality of life. Successful results could lead to tepotinib becoming a widely available treatment option in France. Participants in the study will be randomly assigned to receive either tepotinib or one of the standard treatments. Tepotinib is taken orally, while the standard treatments follow established procedures for lung cancer. The study will primarily measure the success of the treatments by looking at how long patients live without their cancer progressing, along with their overall quality of life and response to the treatment. Although there are potential side effects, such as swelling and gastrointestinal issues, these are generally manageable. The trial's findings could lead to tepotinib being recognized as a valuable treatment option, potentially improving outcomes for patients with this challenging form of lung cancer.

Official TitleA Randomized Controlled Trial of Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer

NCT06908993

Principal SponsorIntergroupe Francophone de Cancerologie Thoracique

Study ContactContact IFCT

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

133 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

15 inclusion criteria required to participate

Informed, written and signed consent: * Patients must have signed and dated the written informed consent form approved by the ethics committee in accordance with the legal and institutional framework. * It must have been signed before protocol-related procedures that are not part of normal patient management are performed. Patients should be willing and able to adhere to the schedule of visits, treatment and laboratory tests.

Histologically proven advanced NSCLC.

Presence of a METex14 mutation (based on local testing). Detection of METex14 mutation should be performed on a tissue sample if available. In case no tissue sample is available, detection of METex14 on a liquid biopsy is authorized. The sponsor should be consulted if there is any doubt about the nature of the mutation.

Evidence of disease progression after at least one prior line of treatment including either a platinum-based chemotherapy or an anti-PD(L)1 agent or both.

Show More Criteria

9 exclusion criteria prevent from participating

Prior treatment with a MET inhibitor (including crizotinib).

Presence of another known driver oncogene alteration (including EGFR, HER2, KRAS, BRAF mutations or ALK, ROS1, RET fusions). In case of detection of any other driver alteration, inclusion should be discussed with the sponsor.

ECOG Performance Status 4.

Known hypersensitivity to tepotinib or its excipients.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Investigator's choice treatment among: * Monochemotherapy (including pemetrexed, docetaxel, paclitaxel with or without bevacizumab, gemcitabine, vinorelbine), * Anti-PD(L)1 agent (including pembrolizumab, nivolumab or atezolizumab), * Best supportive care - available only for patients with i) ECOG PS 3 or ii) contraindication to propose a systemic treatment based on an oncogeriatric assessment or confirmed by the local multidisciplinary tumor board. The treatment chosen cannot be a treatment already received.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 29 locations

Recruiting

Besançon - CHU

Besançon, FranceOpen Besançon - CHU in Google Maps

Recruiting

Bordeaux - Institut Bergonie

Bordeaux, France

Recruiting

Brest - CHU

Brest, France

Recruiting

Caen - CRLCC

Caen, France

Recruiting

29 Study Centers