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New hope for rare lung cancer: targeted pill tepotinib faces final test

NCT ID NCT06908993

Disease control Sponsor: Intergroupe Francophone de Cancerologie Thoracique Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial is testing whether the targeted drug tepotinib works better than standard treatments for people with advanced non-small cell lung cancer that has a specific genetic change (MET exon 14 mutation). About 133 patients who have already tried at least one prior treatment will be randomly assigned to receive either tepotinib pills or one of several standard chemotherapy or immunotherapy options. The main goal is to see if tepotinib delays cancer growth and improves quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tepotinib
What this could lead to
If successful, this trial could provide a new, more effective treatment option for people with a specific type of advanced lung cancer, potentially improving how long they live without their cancer growing and their quality of life.
What could go wrong
This is a Phase 3 trial, but it's relatively small (133 people). Tepotinib can cause side effects like swelling, nausea, and diarrhea, which may be serious in some cases. The benefit in overall survival may be hard to measure because patients in the control group can switch to tepotinib if their cancer worsens.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 133 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. Histologically proven advanced NSCLC. 3. 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. 4. 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. 5. Has received no more than 2 prior lines of treatment. 6. ECOG Performance Status 0-3. 7. Brain metastases are allowed. If immediate local treatment is required, inclusion is possible once the latter is complete. 8. Stage IIIB or IIIC non irradiable or stage IV (8th classification TNM, UICC 2015) 9. Age ≥ 18 years. 10. Adequate biological function: * Creatinine clearance ≥ 30 ml/min; * Neutrophils ≥ 1500/mm3; * Platelets ≥100,000/mm3; * Haemoglobin ≥ 8 g/dL; * Liver enzymes \< 3x ULN except for patients with liver metastases (\< 5x ULN); * Total bilirubin ≤ 1.5 x ULN except for patients with proven Gilbert's syndrome (≤ 5 x ULN) or patients with liver metastases (≤ 3.0 ULN). 11. Protected adults may participate in the study if they are capable of making decisions regarding their medical treatment in accordance with the guardianship judgment. 12. For women of childbearing potential (including women who have had a tubal ligation), serum pregnancy test must be performed and documented as negative within 14 days prior to C1D1. 13. Women of childbearing potential must remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for at least 6 months after the last dose of study drugs. Women must refrain from donating eggs during this same period. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries or uterus). Examples of contraceptive methods with a failure rate of \<1% per year include bilateral tubal ligation, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Hormonal contraceptive methods must be supplemented by a barrier method plus spermicide. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. 14. Men with female partners of childbearing potential or pregnant female partners, must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose of study treatment to avoid exposing the embryo. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. 15. Patient covered by a national health insurance. Exclusion Criteria: 1. Prior treatment with a MET inhibitor (including crizotinib). 2. 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. 3. ECOG Performance Status 4. 4. Known hypersensitivity to tepotinib or its excipients. 5. History of cancer within 3 years or active cancer except those with a negligible risk of metastasis or death, or those treated curatively. If a patient does not fulfil this criterion but the investigator considers that the benefit/risk balance is in favour of inclusion in the study, please contact IFCT. 6. Inability to comply with study or follow-up procedures. 7. Pregnant, lactating, or breastfeeding women. 8. Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that may render the patient at high risk from treatment complications. 9. History of idiopathic pulmonary fibrosis or active pneumonitis on chest computed tomography (CT) scan at screening. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced non-small cell lung cancer MET exon 14 mutation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    29 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HP Hôpital Cochin

    RECRUITING

    Paris, 75014, France

    Contact Email: •••••@•••••

  • AP-HP Hôpital Tenon

    RECRUITING

    Paris, 75970, France

    Contact Email: •••••@•••••

  • Besançon - CHU

    RECRUITING

    Besançon, France

    Contact Email: •••••@•••••

  • Bordeaux - CHU

    RECRUITING

    Pessac, France

    Contact Email: •••••@•••••

  • Bordeaux - Institut Bergonie

    RECRUITING

    Bordeaux, France

    Contact Email: •••••@•••••

  • Brest - CHU

    RECRUITING

    Brest, France

  • CH de Valence

    RECRUITING

    Valence, France

    Contact Email: •••••@•••••

  • CHD Vendée

    RECRUITING

    La Roche-sur-Yon, France

    Contact Email: •••••@•••••

  • CHRU de Lille

    RECRUITING

    Lille, France

    Contact Email: •••••@•••••

  • CHRU de Tours

    RECRUITING

    Tours, France

    Contact Email: •••••@•••••

  • CHU Toulouse

    RECRUITING

    Toulouse, France

    Contact Email: •••••@•••••

  • Caen - CRLCC

    RECRUITING

    Caen, France

    Contact Email: •••••@•••••

  • Centre Antoine Lacassagne

    RECRUITING

    Nice, France

    Contact Email: •••••@•••••

  • Centre Hospitalier Général - Pau

    RECRUITING

    Pau, 64000, France

    Contact Email: •••••@•••••

  • Centre Hospitalier Intercommunal de Créteil

    RECRUITING

    Créteil, 94000, France

    Contact Email: •••••@•••••

  • Centre Léon Bérard

    RECRUITING

    Lyon, 69373, France

  • Dijon - Centre Georges-François Leclerc

    RECRUITING

    Dijon, 21000, France

    Contact Email: •••••@•••••

  • Grenoble - CHU

    RECRUITING

    Grenoble, France

    Contact Email: •••••@•••••

  • Gustave Roussy

    RECRUITING

    Villejuif, France

    Contact Email: •••••@•••••

  • Institut Paoli Calmette

    RECRUITING

    Marseille, France

    Contact Email: •••••@•••••

  • Institut de Cancérologie de l'Ouest - René Gauducheau

    RECRUITING

    Saint-Herblain, 44805, France

  • Le Mans - CHG

    RECRUITING

    Le Mans, France

    Contact Email: •••••@•••••

  • Marseille - APHM

    RECRUITING

    Marseille, France

    Contact Email: •••••@•••••

  • Montpellier - CHU

    RECRUITING

    Montpellier, France

    Contact Email: •••••@•••••

  • Nancy - CHU

    RECRUITING

    Vandœuvre-lès-Nancy, 54500, France

  • Paris - APHP Bichat

    RECRUITING

    Paris, France

    Contact Email: •••••@•••••

  • Sens - CH

    RECRUITING

    Sens, 89100, France

    Contact Email: •••••@•••••

  • Strasbourg - NHC

    RECRUITING

    Strasbourg, 63000, France

    Contact Email: •••••@•••••

  • Toulon - CHI

    RECRUITING

    Toulon, 83000, France

    Contact Email: •••••@•••••

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Other studies related to the condition(s) this trial covers.