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New drug combo shows promise for resistant lung cancer in early trial

NCT ID NCT03940703

Disease control Sponsor: EMD Serono Research & Development Institute, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Updated 3 times

Summary

This phase 2 trial tested a combination of two targeted drugs, tepotinib and osimertinib, in 140 people with advanced non-small cell lung cancer that has a specific genetic change (MET amplification) and had stopped responding to the standard drug osimertinib. The goal was to see if the combination could shrink tumors and control the disease. The study is no longer recruiting, and results are being analyzed.

What this could mean

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

Active substance
Tepotinib and Osimertinib
What this could lead to
If successful, this combination could offer a new treatment option for people with a specific type of lung cancer that has stopped responding to standard therapy.
What could go wrong
This is a phase 2 trial with a small number of participants. The combination may cause significant side effects, and results may not apply to all patients with this cancer type.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

140 people

The number who actually took part.

Started

Sep 2019

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) histology (confirmed by either histology or cytology) with documented activating Epidermal Growth Factor Receptor (EGFR) mutation * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a minimum life expectancy of 12 weeks * Acquired resistance on previous first-line osimertinib. Participants must meet both of the following 2 criteria: * Radiological documentation of disease progression on first-line osimertinib * Objective clinical benefit documented during previous osimertinib therapy, defined by either partial or complete radiological response, or durable stable disease (SD) (SD should last greater than (\>) 6 months after initiation of osimertinib * Have received only first-line osimertinib as a prior line of therapy in the non curative advanced or metastatic NSCLC setting * MET amplification as determined by either FISH testing (central or local) on tumor tissue (TBx) or central blood-based next generation sequencing (LBx). Tumor and blood samples must be collected following progression on prior first-line osimertinib at Prescreening * Submission of tumor tissue and blood sample obtained after progression on first-line osimertinib, is mandatory for all patients for MET amplification testing * Submission of tumor tissue during Prescreening or Screening is mandatory for patients with tumor tissue tested by local FISH, to confirm MET amplification status. Central confirmation is not mandated prior to the start of study treatment * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Spinal cord compression or brain metastasis unless asymptomatic, stable or not requiring steroids for at least 2 weeks prior to start of study intervention * Any unresolved toxicity Grade 2 or more according to National cancer institute common terminology criteria for adverse events( NCI-CTCAE) version 5, from previous anticancer therapy with the exception of alopecia * Inadequate hematological, liver and renal function * Impaired cardiac function * 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) * Contraindication to the administration of osimertinib * Other protocol defined exclusion criteria could apply.

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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.

Non-small cell lung cancer

Contacts and locations

Locations

  • "VitaMed" LLC

    Moscow, Russia

  • AO Ospedali Riuniti Cervello - Presidio Villa Sofia - U.O.S. di Neuroimmunologia

    Palermo, Italy

  • AZ Delta

    Roeselare, Belgium

  • Affiliated Tumor Hospital of Harbin Medical University

    Harbin, China

  • Anhui Chest Hospital

    Hefei, China

  • Asan Medical Center

    Seoul, South Korea

  • Asklepios Fachkliniken Muenchen-Gauting - Abteilung internistische Onkologie

    Gauting, Germany

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57108, United States

  • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - U.O.C. Oncologia

    Verona, Italy

  • Azienda Ospedaliero Universitaria Pisana - U.O. Pneumologia II

    Pisa, Italy

  • Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi) - Oncologia Medica

    Varese, Italy

  • Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo) - U.O Oncologia Medica

    Monza, Italy

  • BHI of Omsk region "Clinical Oncology Dispensary"

    Omsk, Russia

  • Bach Mai Hospital

    Hanoi, Vietnam

  • Baptist Cancer Center

    Memphis, Tennessee, 38120, United States

  • Beacon Health

    South Bend, Indiana, 46601, United States

  • Beacon International Specialist Centre Sdn Bhd

    Kuala Selangor, Malaysia

  • Beijing Hospital

    Beijing, China

  • Boston Medical Center - Dept. Hematology/Oncology

    Boston, Massachusetts, 02118, United States

  • CHU Limoges - Hôpital Dupuytren - Unite d'Oncologie Thoracique et Cutanée

    Limoges, France

  • CHU de Toulouse - Hôpital Larrey - Service de Pneumologie et Oncologie Pneumologique

    Toulouse, France

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256, United States

  • Central Care Cancer Center (CCCC)

    Bolivar, Missouri, 65613, United States

  • Centre Francois Baclesse - Service d'Oncologie Medicale

    Caen, France

  • Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie

    Créteil, France

  • Centre Léon Bérard

    Lyon, France

  • Chi Mei Medical Center, Liou Ying

    Tainan, Taiwan

  • China Medical University Hospital

    Taichung, Taiwan

  • Cho Ray Hospital

    Ho Chi Minh City, Vietnam

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, South Korea

  • Community Cancer Trials of Utah

    Ogden, Utah, 84405, United States

  • Community Health Network

    Indianapolis, Indiana, 46250, United States

  • Compassionate Care Research Group Inc - Edinger Medical Group, Inc.

    Fountain Valley, California, 92708, United States

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169, United States

  • Eastern Connecticut Hematology & Oncology Associates

    Norwich, Connecticut, 06360, United States

  • Evangelisches Krankenhaus Hamm GmbH

    Hamm, Germany

  • Evangelisches Krankenhaus Hamm gGmbH

    Hamm, Germany

  • FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

    Saint Petersburg, Russia

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

    Lazio, Italy

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46845, United States

  • Frederick Health- James M Stockman Cancer Institute

    Frederick, Maryland, 21702, United States

  • Fujian Cancer Hospital

    Fuzhou, China

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325, United States

  • Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha

    Pessac, France

  • Guangdong General Hospital

    Guangzhou, China

  • HCMC Oncology Hospital

    Ho Chi Minh City, Vietnam

  • Hamamatsu University School of Medicine, University Hospital - Dept of Respiratory Medicine

    Hamamatsu, Japan

  • Hawaii Cancer Care

    Honolulu, Hawaii, 96813, United States

  • Hematology Oncology Associates of Fredericksburg

    Fredericksburg, Virginia, 22408, United States

  • Holy Cross

    Fort Lauderdale, Florida, 33308, United States

  • Hopital Albert Calmette - CHU Lille - service de pneumologie et immuno allergologie

    Nord, France

  • Hopital Tenon - service pneumologie

    Paris, France

  • Hospital Cochin Service, Service de Pneumologie et Mucoviscidose

    Paris, France

  • Hospital Pulau Pinang - Clinic Respiratory

    Pulau Pinang, Malaysia

  • Hospital Regional Universitario de Malaga

    Málaga, Spain

  • Hospital Tengku Ampuan Afzan

    Kuantan, Malaysia

  • Hospital Umum Sarawak

    Kuching, Malaysia

  • Hospital Universitari Dexeus - Servicio de Oncologia Medica

    Barcelona, Spain

  • Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica

    Barcelona, Spain

  • Hospital Universitari Son Espases - Servicio de Oncologia Medica

    Palma, Spain

  • Hospital Universitari Vall d'Hebron - Dept of Oncology

    Barcelona, Spain

  • Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica

    Valencia, Spain

  • Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia

    Madrid, Spain

  • Hospital Universitario Materno-Infantil de Canarias - Servicio de Oncologia

    Las Palmas de Gran Canaria, Spain

  • Hospital Universitario Quiron Madrid - Unidad Integral de Oncologia

    Pozuelo de Alarcón, Spain

  • Hospital Universitario Virgen Macarena - Servicio de Oncologia

    Seville, Spain

  • Hospital del Mar - Servicio de Oncologia

    Barcelona, Spain

  • Hubei Cancer Hospital

    Wuhan, China

  • Hunan Cancer Hospital

    Changsha, China

  • Hyogo College of Medicine Hospital - Dept of Respiratory Medicine

    Nishinomiya-shi, Japan

  • ICO Badalona - Hospital Germans Trias i Pujol - Servicio de Oncologia Medica

    Badalona, Spain

  • ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia

    L'Hospitalet de Llobregat, Spain

  • IEO Istituto Europeo di Oncologia

    Milan, Italy

  • IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2

    Padova, Italy

  • Icon Cancer Centre

    Connexion, Singapore

  • Innovative Clinical Research Institute

    Whittier, California, 92801, United States

  • Istituto Clinico Humanitas

    Rozzano, Italy

  • Istituto Nazionale Tumori Regina Elena IRCCS - S.C. Oncologia Medica B

    Roma, Italy

  • Jiangsu Province Hospital

    Nanjing, China

  • Jilin Cancer Hospital - Oncology

    Changchun, China

  • K Hospital

    Hanoi, Vietnam

  • Kanagawa Cancer Center - Dept of Respiratory Medicine

    Yokohama, Japan

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, Taiwan

  • Kindai University Hospital

    Osakasayama-shi, Japan

  • King Chulalongkorn Memorial Hospital

    Pathumwan, Thailand

  • Korea University Anam Hospital

    Seoul, South Korea

  • Kurume University Hospital

    Kurume-shi, Japan

  • LLC "ClinicaUZI4D"

    Pyatigorsk, Russia

  • LLC "Tonus"

    Nizniy Novgorod, Russia

  • Liaoning Cancer Hospital & Institute

    Shenyang, China

  • Linyi Tumor Hospital

    Linyi, China

  • Maastricht University Medical Center - Dept of Medical Oncology

    Maastricht, Netherlands

  • Maharaj Nakorn Chiang Mai Hospital

    Muang, Thailand

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230, United States

  • Medstar Franklin Square Clinical Research Center

    Baltimore, Maryland, 21237, United States

  • Memorial Care

    Long Beach, California, 90806, United States

  • Memorial Healthcare System

    Hollywood, Florida, 33021, United States

  • Missionsärztliche Klinik

    Würzburg, Germany

  • Mosaic Life Care

    Saint Joseph, Missouri, 64507, United States

  • NHO Yamaguchi - Ube Medical Center

    Ube-shi, Japan

  • NYU Langone Clinical Cancer Center - NYU Langone Medical Cente

    New York, New York, 10016, United States

  • NYU Langone Clinical Cancer Center - NYU Langone Medical Center

    New York, New York, 10016, United States

  • Nagoya University Hospital - Dept of Respiratory Medicine

    Nagoya, Japan

  • National Cancer Center

    Goyang-si, South Korea

  • National Cancer Centre - Medical Oncology Pharmacy

    Singapore, Singapore

  • National Lungs Hospital

    Hanoi, Vietnam

  • National Taiwan University Hospital

    Taipei, Taiwan

  • New Jersey Cancer Care and Blood Disorders

    Belleville, New Jersey, 07109, United States

  • Niigata Cancer Center Hospital - Dept of Internal Medicine

    Niigata, Japan

  • Northwest Medical Specialties

    Tacoma, Washington, 98405, United States

  • Norton Cancer Institute

    Louisville, Kentucky, 40202, United States

  • Ocala Oncology

    Ocala, Florida, 34474, United States

  • OhioHealth

    Columbus, Ohio, 43214, United States

  • Okayama University Hospital - Dept of Respiratory Medicine/Allergy

    Okayama, Japan

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa, Oklahoma, 74146, United States

  • Oregon Oncology Specialists

    Salem, Oregon, 97301, United States

  • Osaka City General Hospital

    Osaka, Japan

  • Ospedale Monaldi

    Naples, Italy

  • POIS Leipzig GbR

    Leipzig, Germany

  • Pantai Hospital Kuala Lumpur

    Kuala Lumpur, Malaysia

  • Pavlov First Saint Petersburg State Medical University - Research Institute of Pulmunology

    Saint Petersburg, Russia

  • Peking Union Medical College Hospital

    Beijing, China

  • Peking University Cancer Hospital

    Beijing, China

  • Pham Ngoc Thach Hospital

    Ho Chi Minh City, Vietnam

  • Pius-Hospital Oldenburg - Klinik f. Haematologie und Onkologie

    Oldenburg, Germany

  • Pontchartrain

    Hammond, Louisiana, 70433, United States

  • Queen Elizabeth Hospital - Department of Medicine

    Hong Kong, Hong Kong

  • SBHI "Krasnoyarsk Regional Oncology Dispensary n.a. A.I. Kryzhanovsky"

    Krasnoyarsk, Russia

  • Saitama Cancer Center

    Kitaadachi-gun, Japan

  • Samsung Medical Center

    Seoul, South Korea

  • Sanford Health

    Sioux Falls, South Dakota, 57104, United States

  • Seoul National University Bundang Hospital

    Seongnam-si, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Shanghai Cancer Hospital, Fudan University

    Shanghai, China

  • Shanghai Chest Hospital

    Shanghai, China

  • Siriraj Hospital

    Bangkoknoi, Thailand

  • Songklanagarind Hospital

    Hat Yai, Thailand

  • Southcoast Center for Cancer Care

    Fairhaven, Massachusetts, 02719, United States

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534, United States

  • Sparrow Hospital Herbert - Herman Cancer Center

    Lansing, Michigan, 48912, United States

  • St. Louis Cancer Care, LLP

    Bridgeton, Missouri, 63044, United States

  • Staedtisches Krankenhaus Kiel

    Kiel, Germany

  • Summit Medical Group

    Florham Park, New Jersey, 07932, United States

  • Sunway Medical Centre

    Petaling Jaya, Selangor, Malaysia

  • Taichung Veterans General Hospital

    Taichung, Taiwan

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • Tan Tock Seng Hospital - CTRU/OCS, Research

    Singapore, Singapore

  • Tennessee Oncology

    Nashville, Tennessee, 37201, United States

  • The Affiliated Cancer Hospital of Xinjiang Medical university

    Ürümqi, China

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, South Korea

  • The Center for Cancer & Blood Disorders - Maryland

    Bethesda, Maryland, 20817, United States

  • The Chinese University of Hong Kong - Emergency Medicine

    Shatin, Hong Kong

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, China

  • The First Hospital of Jilin University

    Changchun, China

  • The Netherlands Cancer Institute

    Amsterdam, Netherlands

  • The University of Hong Kong

    Hong Kong, Hong Kong

  • Thoraxklinik-Heidelberg gGmbH

    Heidelberg, Germany

  • Tri-Service General Hospital

    Taipei, Taiwan

  • UZ Antwerpen - Department of Oncology

    Edegem, Belgium

  • UZ Leuven

    Gasthuisberg, Belgium

  • Ulsan University Hospital

    Ulsan, South Korea

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, China

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, Germany

  • Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen

    Giessen, Germany

  • Universitaetsklinikum Koeln - Innere Medizin I, Onkologie, Haematologie

    Cologne, Germany

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck, Germany

  • Universitaetsmedizin Goettingen

    Göttingen, Germany

  • Universitair Medisch Centrum Groningen - Department of Internal Medicine

    Groningen, Netherlands

  • University Cancer and Blood Center

    Athens, Georgia, 30607, United States

  • University Hospitals Seidman

    Cleveland, Ohio, 44106, United States

  • University Malaya Medical Centre

    Kuala Lumpur, Malaysia

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical Oncology

    Houston, Texas, 77030, United States

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106, United States

  • Ventura County Hematology Oncology Specialists

    Oxnard, California, 93030, United States

  • Weill Cornell Medical College - Gastroenterology

    New York, New York, 10021, United States

  • West China Hospital, Sichuan University

    Chengdu, China

  • Yuma Regional Medical Center

    Yuma, Arizona, 85364, United States

  • Zhejiang Cancer Hospital

    Hangzhou, China

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