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ACTIVE NOT RECRUITING
NCT03940703
PHASE2

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

Sponsor: EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

Summary

This study was to assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

Official title: A Phase II, Two-arm Study to Investigate Tepotinib Combined With Osimertinib in MET Amplified, Advanced or Metastatic NSCLC Harboring Activating EGFR Mutations and Having Acquired Resistance to Prior Osimertinib Therapy (INSIGHT 2)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2019-09-19

Completion Date

2026-05-01

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

DRUG

Tepotinib

Participants were administered with Tepotinib orally once daily at a dose of 500 mg.

DRUG

Osimertinib

Participants received Osimertinib at a dose of 80 mg orally once daily.

Locations (179)

Yuma Regional Medical Center

Yuma, Arizona, United States

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

Fountain Valley, California, United States

Memorial Care

Long Beach, California, United States

Ventura County Hematology Oncology Specialists

Oxnard, California, United States

Innovative Clinical Research Institute

Whittier, California, United States

Eastern Connecticut Hematology & Oncology Associates

Norwich, Connecticut, United States

Holy Cross

Fort Lauderdale, Florida, United States

Memorial Healthcare System

Hollywood, Florida, United States

Cancer Specialists of North Florida

Jacksonville, Florida, United States

Ocala Oncology

Ocala, Florida, United States

University Cancer and Blood Center

Athens, Georgia, United States

Hawaii Cancer Care

Honolulu, Hawaii, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

Community Health Network

Indianapolis, Indiana, United States

Beacon Health

South Bend, Indiana, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Pontchartrain

Hammond, Louisiana, United States

Medstar Franklin Square Clinical Research Center

Baltimore, Maryland, United States

The Center for Cancer & Blood Disorders - Maryland

Bethesda, Maryland, United States

Frederick Health- James M Stockman Cancer Institute

Frederick, Maryland, United States

Boston Medical Center - Dept. Hematology/Oncology

Boston, Massachusetts, United States

Southcoast Center for Cancer Care

Fairhaven, Massachusetts, United States

Sparrow Hospital Herbert - Herman Cancer Center

Lansing, Michigan, United States

Central Care Cancer Center (CCCC)

Bolivar, Missouri, United States

St. Louis Cancer Care, LLP

Bridgeton, Missouri, United States

Mosaic Life Care

Saint Joseph, Missouri, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

New Jersey Cancer Care and Blood Disorders

Belleville, New Jersey, United States

Summit Medical Group

Florham Park, New Jersey, United States

NYU Langone Clinical Cancer Center - NYU Langone Medical Center

New York, New York, United States

NYU Langone Clinical Cancer Center - NYU Langone Medical Cente

New York, New York, United States

Weill Cornell Medical College - Gastroenterology

New York, New York, United States

Southeastern Medical Oncology Center

Goldsboro, North Carolina, United States

University Hospitals Seidman

Cleveland, Ohio, United States

OhioHealth

Columbus, Ohio, United States

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, United States

Oregon Oncology Specialists

Salem, Oregon, United States

Gettysburg Cancer Center

Gettysburg, Pennsylvania, United States

Sanford Health

Sioux Falls, South Dakota, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Baptist Cancer Center

Memphis, Tennessee, United States

Tennessee Oncology

Nashville, Tennessee, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

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

Houston, Texas, United States

Community Cancer Trials of Utah

Ogden, Utah, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

Hematology Oncology Associates of Fredericksburg

Fredericksburg, Virginia, United States

Northwest Medical Specialties

Tacoma, Washington, United States

UZ Antwerpen - Department of Oncology

Edegem, Belgium

UZ Leuven

Gasthuisberg, Belgium

AZ Delta

Roeselare, Belgium

Beijing Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

Peking University Cancer Hospital

Beijing, China

Jilin Cancer Hospital - Oncology

Changchun, China

The First Hospital of Jilin University

Changchun, China

Hunan Cancer Hospital

Changsha, China

West China Hospital, Sichuan University

Chengdu, China

Fujian Cancer Hospital

Fuzhou, China

Guangdong General Hospital

Guangzhou, China

The First Affiliated Hospital, Zhejiang University

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Affiliated Tumor Hospital of Harbin Medical University

Harbin, China

Anhui Chest Hospital

Hefei, China

Linyi Tumor Hospital

Linyi, China

Jiangsu Province Hospital

Nanjing, China

Shanghai Cancer Hospital, Fudan University

Shanghai, China

Shanghai Chest Hospital

Shanghai, China

Liaoning Cancer Hospital & Institute

Shenyang, China

The Affiliated Cancer Hospital of Xinjiang Medical university

Ürümqi, China

Hubei Cancer Hospital

Wuhan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Centre Francois Baclesse - Service d'Oncologie Medicale

Caen, France

Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie

Créteil, France

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

Limoges, France

Centre Léon Bérard

Lyon, France

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

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

Pessac, France

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

Toulouse, France

Universitaetsklinikum Koeln - Innere Medizin I, Onkologie, Haematologie

Cologne, Germany

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, Germany

Asklepios Fachkliniken Muenchen-Gauting - Abteilung internistische Onkologie

Gauting, Germany

Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen

Giessen, Germany

Universitaetsmedizin Goettingen

Göttingen, Germany

Evangelisches Krankenhaus Hamm gGmbH

Hamm, Germany

Evangelisches Krankenhaus Hamm GmbH

Hamm, Germany

Thoraxklinik-Heidelberg gGmbH

Heidelberg, Germany

Staedtisches Krankenhaus Kiel

Kiel, Germany

POIS Leipzig GbR

Leipzig, Germany

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

Lübeck, Germany

Pius-Hospital Oldenburg - Klinik f. Haematologie und Onkologie

Oldenburg, Germany

Missionsärztliche Klinik

Würzburg, Germany

Queen Elizabeth Hospital - Department of Medicine

Hong Kong, Hong Kong

The University of Hong Kong

Hong Kong, Hong Kong

The Chinese University of Hong Kong - Emergency Medicine

Shatin, Hong Kong

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

Lazio, Italy

IEO Istituto Europeo di Oncologia

Milan, Italy

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

Monza, Italy

Ospedale Monaldi

Naples, Italy

IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2

Padova, Italy

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

Palermo, Italy

Azienda Ospedaliero Universitaria Pisana - U.O. Pneumologia II

Pisa, Italy

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

Roma, Italy

Istituto Clinico Humanitas

Rozzano, Italy

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

Varese, Italy

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

Verona, Italy

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

Hamamatsu, Japan

Saitama Cancer Center

Kitaadachi-gun, Japan

Kurume University Hospital

Kurume-shi, Japan

Nagoya University Hospital - Dept of Respiratory Medicine

Nagoya, Japan

Niigata Cancer Center Hospital - Dept of Internal Medicine

Niigata, Japan

Hyogo College of Medicine Hospital - Dept of Respiratory Medicine

Nishinomiya-shi, Japan

Okayama University Hospital - Dept of Respiratory Medicine/Allergy

Okayama, Japan

Osaka City General Hospital

Osaka, Japan

Kindai University Hospital

Osakasayama-shi, Japan

NHO Yamaguchi - Ube Medical Center

Ube-shi, Japan

Kanagawa Cancer Center - Dept of Respiratory Medicine

Yokohama, Japan

Pantai Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Beacon International Specialist Centre Sdn Bhd

Kuala Selangor, Malaysia

Hospital Tengku Ampuan Afzan

Kuantan, Malaysia

Hospital Umum Sarawak

Kuching, Malaysia

Sunway Medical Centre

Petaling Jaya, Selangor, Malaysia

Hospital Pulau Pinang - Clinic Respiratory

Pulau Pinang, Malaysia

The Netherlands Cancer Institute

Amsterdam, Netherlands

Universitair Medisch Centrum Groningen - Department of Internal Medicine

Groningen, Netherlands

Maastricht University Medical Center - Dept of Medical Oncology

Maastricht, Netherlands

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

Krasnoyarsk, Russia

"VitaMed" LLC

Moscow, Russia

LLC "Tonus"

Nizniy Novgorod, Russia

BHI of Omsk region "Clinical Oncology Dispensary"

Omsk, Russia

LLC "ClinicaUZI4D"

Pyatigorsk, Russia

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

Saint Petersburg, Russia

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

Saint Petersburg, Russia

Icon Cancer Centre

Connexion, Singapore

National Cancer Centre - Medical Oncology Pharmacy

Singapore, Singapore

Tan Tock Seng Hospital - CTRU/OCS, Research

Singapore, Singapore

National Cancer Center

Goyang-si, South Korea

Chonnam National University Hwasun Hospital

Hwasun-gun, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Asan Medical Center

Seoul, South Korea

Korea University Anam Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

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

Seoul, South Korea

Ulsan University Hospital

Ulsan, South Korea

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

Badalona, Spain

Hospital del Mar - Servicio de Oncologia

Barcelona, Spain

Hospital Universitari Dexeus - Servicio de Oncologia Medica

Barcelona, Spain

Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica

Barcelona, Spain

Hospital Universitari Vall d'Hebron - Dept of Oncology

Barcelona, Spain

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

L'Hospitalet de Llobregat, Spain

Hospital Universitario Materno-Infantil de Canarias - Servicio de Oncologia

Las Palmas de Gran Canaria, Spain

Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia

Madrid, Spain

Hospital Regional Universitario de Malaga

Málaga, Spain

Hospital Universitari Son Espases - Servicio de Oncologia Medica

Palma, Spain

Hospital Universitario Quiron Madrid - Unidad Integral de Oncologia

Pozuelo de Alarcón, Spain

Hospital Universitario Virgen Macarena - Servicio de Oncologia

Seville, Spain

Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica

Valencia, Spain

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Chi Mei Medical Center, Liou Ying

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Siriraj Hospital

Bangkoknoi, Thailand

Songklanagarind Hospital

Hat Yai, Thailand

Maharaj Nakorn Chiang Mai Hospital

Muang, Thailand

King Chulalongkorn Memorial Hospital

Pathumwan, Thailand

Bach Mai Hospital

Hanoi, Vietnam

K Hospital

Hanoi, Vietnam

National Lungs Hospital

Hanoi, Vietnam

Cho Ray Hospital

Ho Chi Minh City, Vietnam

HCMC Oncology Hospital

Ho Chi Minh City, Vietnam

Pham Ngoc Thach Hospital

Ho Chi Minh City, Vietnam