Lung Cancer Clinical Trial

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

Summary

This study will 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).

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT03940703

Recruitment Status:

Recruiting

Sponsor:

EMD Serono Research & Development Institute, Inc.

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There are 49 Locations for this study

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Yuma Regional Medical Center
Yuma Arizona, 85364, United States
Compassionate Care Research Group Inc - Edinger Medical Group, Inc.
Fountain Valley California, 92708, United States
Memorial Care
Long Beach California, 90806, United States
Ventura County Hematology Oncology Specialists
Oxnard California, 93030, United States
Innovative Clinical Research Institute
Whittier California, 92801, United States
Eastern Connecticut Hematology & Oncology Associates
Norwich Connecticut, 06360, United States
Holy Cross
Fort Lauderdale Florida, 33308, United States
Memorial Healthcare System
Hollywood Florida, 33021, United States
Cancer Specialists of North Florida
Jacksonville Florida, 32256, United States
University of Miami Miller School of Medicine
Miami Florida, 33136, United States
Ocala Oncology
Ocala Florida, 34474, United States
University Cancer and Blood Center
Athens Georgia, 30607, United States
Hawaii Cancer Care
Honolulu Hawaii, 96813, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne Indiana, 46845, United States
Community Health Network
Indianapolis Indiana, 46250, United States
Beacon Health
South Bend Indiana, 46601, United States
Norton Cancer Institute
Louisville Kentucky, 40202, United States
Pontchartrain
Hammond Louisiana, 70433, United States
Medstar Franklin Square Clinical Research Center
Baltimore Maryland, 21237, United States
The Center for Cancer & Blood Disorders - Maryland
Bethesda Maryland, 20817, United States
Frederick Health- James M Stockman Cancer Institute
Frederick Maryland, 21702, United States
Boston Medical Center - Dept. Hematology/Oncology
Boston Massachusetts, 02118, United States
Southcoast Center for Cancer Care
Fairhaven Massachusetts, 02719, United States
Sparrow Hospital Herbert - Herman Cancer Center
Lansing Michigan, 48912, United States
Central Care Cancer Center (CCCC)
Bolivar Missouri, 65613, United States
St. Louis Cancer Care, LLP
Bridgeton Missouri, 63044, United States
Mosaic Life Care
Saint Joseph Missouri, 64507, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States
New Jersey Cancer Care and Blood Disorders
Belleville New Jersey, 07109, United States
Summit Medical Group
Florham Park New Jersey, 07932, United States
NYU Langone Clinical Cancer Center - NYU Langone Medical Center
New York New York, 10016, United States
NYU Langone Clinical Cancer Center - NYU Langone Medical Cente
New York New York, 10016, United States
Weill Cornell Medical College - Gastroenterology
New York New York, 10021, United States
Southeastern Medical Oncology Center
Goldsboro North Carolina, 27534, United States
University Hospitals Seidman
Cleveland Ohio, 44106, United States
OhioHealth
Columbus Ohio, 43214, United States
Oklahoma Cancer Specialists and Research Institute
Tulsa Oklahoma, 74146, United States
Oregon Oncology Specialists
Salem Oregon, 97301, United States
Gettysburg Cancer Center
Gettysburg Pennsylvania, 17325, United States
Sanford Health
Sioux Falls South Dakota, 57104, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57108, United States
Baptist Cancer Center
Memphis Tennessee, 38120, United States
Tennessee Oncology
Nashville Tennessee, 37201, United States
Mary Crowley Cancer Research
Dallas Texas, 75230, United States
University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical Oncology
Houston Texas, 77030, United States
Community Cancer Trials of Utah
Ogden Utah, 84405, United States
Utah Cancer Specialists
Salt Lake City Utah, 84106, United States
Hematology Oncology Associates of Fredericksburg
Fredericksburg Virginia, 22408, United States
Northwest Medical Specialties
Tacoma Washington, 98405, United States
UZ Antwerpen - Department of Oncology
Edegem , , Belgium
UZ Leuven
Gasthuisberg , , Belgium
AZ Delta
Roeselare , , Belgium
Beijing Hospital
Beijing , , China More Info
Lin Li
Principal Investigator
Peking Union Medical College Hospital
Beijing , , China More Info
Li Zhang
Principal Investigator
Peking University Cancer Hospital
Beijing , , China More Info
Jian Fang
Principal Investigator
Peking University Cancer Hospital
Beijing , , China More Info
Jun Zhao
Principal Investigator
Jilin Cancer Hospital - Oncology
Changchun , , China More Info
Ying Cheng
Principal Investigator
The First Hospital of Jilin University
Changchun , , China More Info
Jiuwei Cui
Principal Investigator
Hunan Cancer Hospital
Changsha , , China More Info
Nong Yang
Principal Investigator
West China Hospital, Sichuan University
Chengdu , , China More Info
Qinghua Zhou
Principal Investigator
Fujian Cancer Hospital
Fuzhou , , China More Info
Cheng Huang
Principal Investigator
Guangdong General Hospital
Guangzhou , , China More Info
Jinji Yang
Principal Investigator
The First Affiliated Hospital, Zhejiang University
Hangzhou , , China More Info
Jianying Zhou
Principal Investigator
Zhejiang Cancer Hospital
Hangzhou , , China More Info
Yiping Zhang
Principal Investigator
Affiliated Tumor Hospital of Harbin Medical University
Harbin , , China More Info
Gongyan Chen
Principal Investigator
Anhui Chest Hospital
Hefei , , China More Info
Xuhong Min
Principal Investigator
Linyi Tumor Hospital
Linyi , , China
Jiangsu Province Hospital
Nanjing , , China More Info
Yongqian Shu
Principal Investigator
Shanghai Cancer Hospital, Fudan University
Shanghai , , China More Info
Jialei Wang
Principal Investigator
Shanghai Chest Hospital
Shanghai , , China More Info
Baohui Han
Principal Investigator
Liaoning Cancer Hospital & Institute
Shenyang , , China More Info
Rui Ma
Principal Investigator
The Affiliated Cancer Hospital of Xinjiang Medical university
Urumqi , , China
Hubei Cancer Hospital
Wuhan , , China More Info
Sheng Hu
Principal Investigator
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan , , China More Info
Gang Wu
Principal Investigator
Centre Francois Baclesse - Service d'Oncologie Medicale
Caen Cedex 05 , , France
Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie
Creteil Cedex , , 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
Hospital Cochin Service, Service de Pneumologie et Mucoviscidose
Paris cedex 14 , , France
Hopital Tenon - service pneumologie
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 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
Universitaetsklinikum Koeln - Innere Medizin I, Onkologie, Haematologie
Koeln , , Germany
POIS Leipzig GbR
Leipzig , , Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Luebeck , , Germany
Pius-Hospital Oldenburg - Klinik f. Haematologie und Onkologie
Oldenburg , , Germany
Missionsärztliche Klinik
Wuerzburg , , 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
Milano , , Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo) - U.O Oncologia Medica
Monza , , Italy
Ospedale Monaldi
Napoli , , 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-shi , , Japan
Saitama Cancer Center
Kitaadachi-gun , , Japan
Kurume University Hospital
Kurume-shi , , Japan
Nagoya University Hospital - Dept of Respiratory Medicine
Nagoya-shi , , Japan
Niigata Cancer Center Hospital - Dept of Internal Medicine
Niigata-shi , , Japan
Hyogo College of Medicine Hospital - Dept of Respiratory Medicine
Nishinomiya-shi , , Japan
Okayama University Hospital - Dept of Respiratory Medicine/Allergy
Okayama-shi , , Japan
Osaka City General Hospital
Osaka-shi , , Japan
Kindai University Hospital
Osakasayama-shi , , Japan
NHO Yamaguchi - Ube Medical Center
Ube-shi , , Japan
Kanagawa Cancer Center - Dept of Respiratory Medicine
Yokohama-shi , , Japan
National Cancer Center
Goyang-si , , Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun-gun , , Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , , Korea, Republic of
Asan Medical Center
Seoul , , Korea, Republic of
Korea University Anam Hospital
Seoul , , Korea, Republic of
Samsung Medical Center
Seoul , , Korea, Republic of
Seoul National University Hospital
Seoul , , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul , , Korea, Republic of
Ulsan University Hospital
Ulsan , , Korea, Republic of
Pantai Hospital Kuala Lumpur
Kuala Lumpur , , Malaysia
University Malaya Medical Centre
Kuala Lumpur , , 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
Beacon International Specialist Centre Sdn Bhd
Selangor , , 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 , , Russian Federation
"VitaMed" LLC
Moscow , , Russian Federation
LLC "Tonus"
Nizniy Novgorod , , Russian Federation
BHI of Omsk region "Clinical Oncology Dispensary"
Omsk , , Russian Federation
LLC "ClinicaUZI4D"
Pyatigorsk , , Russian Federation
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
Saint-Petersburg , , Russian Federation
Pavlov First Saint Petersburg State Medical University - Research Institute of Pulmunology
St. Petersburg , , Russian Federation
Icon Cancer Centre
Connexion , , Singapore
National Cancer Centre - Medical Oncology Pharmacy
Singapore , , Singapore
Tan Tock Seng Hospital - CTRU/OCS, Research
Singapore , , Singapore
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 Alarcon , , Spain
Hospital Universitario Virgen Macarena - Servicio de Oncologia
Sevilla , , Spain
Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica
Valencia , , Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung , , 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

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT03940703

Recruitment Status:

Recruiting

Sponsor:


EMD Serono Research & Development Institute, Inc.

How clear is this clinincal trial information?

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