Clinical trial NCT03940703: A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Tepotinib
Osimertinib
Non-Small Cell Lung Cancer
INSIGHT 2
MET amplified
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2019-05-07
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


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.

Primary outcomes:
measure: Combined Therapy (Tepotinib+Osimertinib): Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version (NCI-CTCAE v 5.0)
timeFrame: Up to Day 21 of Cycle 1 (each Cycle is of 21 days)
measure: Combined Therapy: Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1as Per Independent Review Committee in Participants With MET Amplification Determined Centrally by Fluorescence in Situ Hybridization(FISH)
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
Secondary outcomes:
measure: Combined Therapy: Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1as Per Independent Review Committee in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Monotherapy (Tepotinib): Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1 as Per Independent Review Committee in Participants With MET Amplification Determined Centrally by FISH
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Number of Participants With Clinically Significant Abnormalities in Laboratory Values Reported as Treatment Related TEAEs
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Number of Participants With Markedly Abnormal Vital Sign Measurements
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score Versus (Vs) Worst Post-baseline Score
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Combined Therapy: Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1 Assessed by Investigator in Participants With MET Amplification Determined Centrally by FISH
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Combined Therapy (Tepotinib + Osimertinib): Number of Participants With Confirmed Complete Response (CR) Assessed by Independent Review Committee in Participants With MET Amplification Determined Centrally by FISH
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Combined Therapy (Tepotinib + Osimertinib): Number of Participants With Confirmed Complete Response (CR) Assessed by Investigator in Participants With MET Amplification Determined Centrally by FISH
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Combined Therapy (Tepotinib + Osimertinib): Duration of Response Assessed by Independent Review Committee in Participants With MET Amplification Determined Centrally by FISH
timeFrame: From first documented objective response to PD or death due to any cause, assessed approximately up to 42 months
measure: Combined Therapy (Tepotinib + Osimertinib): Duration of Response Assessed by Investigator in Participants With MET Amplification Determined Centrally by FISH
timeFrame: From first documented objective response to PD or death due to any cause, assessed approximately up to 42 months
measure: Combined Therapy (Tepotinib + Osimertinib): Disease Control Rate Assessed by Independent Review Committee in Participants With MET Amplification Determined Centrally by FISH
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Combined Therapy (Tepotinib + Osimertinib): Disease Control Rate Assessed by Investigator in Participants With MET Amplification Determined Centrally by FISH
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Combined Therapy (Tepotinib + Osimertinib): Progression-Free Survival (PFS) According to RECIST Version1.1 as Assessed by the Independent Review Committee in Participants With MET Amplification Determined Centrally by FISH
timeFrame: Time from first administration of study treatment to the date of the first documentation of PD or death due to any cause, assessed approximately up to 42 months
measure: Combined Therapy (Tepotinib + Osimertinib): Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1as Assessed by the Investigator in Participants With MET Amplification Determined Centrally by FISH
timeFrame: time from first administration of study treatment to the date of the first documentation of PD or death due to any cause, assessed approximately up to 42 months
measure: Combined Therapy (Tepotinib + Osimertinib): Overall Survival in Participants With MET Amplification Determined Centrally by FISH
timeFrame: Time from first administration of study treatment to the date of death, assessed approximately up to 42 months
measure: Combined Therapy: Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1as Assessed by Investigator in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Combined Therapy (Tepotinib + Osimertinib): Number of Participants With Confirmed Complete Response (CR) Assessed by Independent Review Committee in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Combined Therapy (Tepotinib + Osimertinib): Number of Participants With Confirmed Complete Response (CR) Assessed by Investigator in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Combined Therapy (Tepotinib + Osimertinib): Duration of Response Assessed by Independent Review Committee in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing
timeFrame: From first documented objective response to PD or death due to any cause, assessed approximately up to 42 months
measure: Combined Therapy (Tepotinib + Osimertinib): Duration of Response Assessed by Investigator in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing
timeFrame: From first documented objective response to PD or death due to any cause, assessed approximately up to 42 months
measure: Combined Therapy (Tepotinib + Osimertinib): Disease Control Rate Assessed by Independent Review Committee in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Combined Therapy (Tepotinib + Osimertinib): Disease Control Rate Assessed by Investigator in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Combined Therapy (Tepotinib + Osimertinib): Progression-Free Survival (PFS) According to RECIST Version1.1 as Per Independent Review Committee in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing
timeFrame: Time from first administration of study treatment to the date of the first documentation of PD or death due to any cause, assessed approximately up to 42 months
measure: Combined Therapy ((Tepotinib + Osimertinib): Progression-Free Survival (PFS) According to RECIST Version1.1 as Assessed by the Investigator in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing
timeFrame: Time from first administration of study treatment to the date of the first documentation of PD or death due to any cause, assessed approximately up to 42 months
measure: Combined Therapy (Tepotinib + Osimertinib): Overall Survival in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing
timeFrame: Time from first administration of study treatment to the date of death, assessed approximately up to 42 months
measure: Monotherapy (Tepotinib): Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1as Per Investigator in Participants With MET Amplification Determined Centrally by Fluorescence in Situ Hybridization(FISH)
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Monotherapy (Tepotinib): Number of Participants With Confirmed Complete Response (CR) Assessed by Independent Review Committee in Participants With MET Amplification Determined Centrally by FISH
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Monotherapy (Tepotinib): Number of Participants With Confirmed Complete Response (CR) Assessed by Investigator in Participants With MET Amplification Determined Centrally by FISH
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Monotherapy (Tepotinib): Duration of Response Assessed by Independent Review Committee in Participants With MET Amplification Determined Centrally by FISH
timeFrame: From first documented objective response to PD or death due to any cause, assessed approximately up to 42 months
measure: Monotherapy (Tepotinib): Duration of Response Assessed by Investigator in Participants With MET Amplification Determined Centrally by FISH
timeFrame: From first documented objective response to PD or death due to any cause, assessed approximately up to 42 months
measure: Monotherapy (Tepotinib): Disease Control Rate Assessed by Independent Review Committee in Participants With MET Amplification Determined Centrally by FISH
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Monotherapy (Tepotinib): Disease Control Rate Assessed by Investigator in Participants With MET Amplification Determined Centrally by FISH
timeFrame: Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
measure: Monotherapy (Tepotinib): Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1as Assessed by the Independent Review Committee in Participants With MET Amplification Determined Centrally by FISH
timeFrame: Time from first administration of study treatment to the date of the first documentation of PD or death due to any cause, assessed approximately up to 42 months
measure: Monotherapy (Tepotinib): Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1as Assessed by the Investigator in Participants With MET Amplification Determined Centrally by FISH
timeFrame: Time from first administration of study treatment to the date of the first documentation of PD or death due to any cause, assessed approximately up to 42 months
measure: Combined Therapy (Tepotinib + Osimertinib): Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Safety Follow-up (42 Months)
timeFrame: Baseline, safety follow-up (assessed up to 42 months)
measure: Combined Therapy (Tepotinib + Osimertinib): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status) at Safety Follow-up (42 Months)
timeFrame: Baseline, safety follow-up (up to 42 months)
measure: Combined Therapy (Tepotinib + Osimertinib): Change From Baseline in Health-Related Quality of Life as Assessed by Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) at Safety Follow-up (42 Months)
timeFrame: Baseline, safety follow-up (up to 42 months)
measure: Combined Therapy (Tepotinib + Osimertinib): Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t) of Tepotinib and Its Metabolites (MSC2571109A, MSC2571107A), Osimertinib and Its Metabolite AZD5104
timeFrame: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after tepotinib and Osimertinib administration at Day 1 of Cycle 1 and Day 15 of Cycle 1 (each Cycle is of 21 days) ]
measure: Combined Therapy (Tepotinib + Osimertinib): Maximum Observed Plasma Concentration (Cmax) of Tepotinib and Its Metabolites (MSC2571109A, MSC2571107A), Osimertinib and Its Metabolite AZD5104
timeFrame: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after tepotinib and Osimertinib administration at Day 1 of Cycle 1 and Day 15 of Cycle 1 (each Cycle is of 21 days) ]
measure: Combined Therapy (Tepotinib + Osimertinib): Time to Reach Maximum Observed Plasma Concentration (Tmax) of Tepotinib and Its Metabolites (MSC2571109A, MSC2571107A), Osimertinib and Its Metabolite AZD5104
timeFrame: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after tepotinib and Osimertinib administration at Day 1 of Cycle 1 and Day 15 of Cycle 1 (each Cycle is of 21 days) ]
measure: Combined Therapy (Tepotinib + Osimertinib): Apparent Total Body Clearance (CL/f) of Tepotinib and Its Metabolites (MSC2571109A, MSC2571107A), Osimertinib and Its Metabolite AZD5104
timeFrame: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after tepotinib and Osimertinib administration at Day 1 of Cycle 1 and Day 15 of Cycle 1 (each Cycle is of 21 days) ]
measure: Combined Therapy (Tepotinib + Osimertinib): Apparent Volume Of Distribution (Vz/F) of of Tepotinib and Its Metabolites (MSC2571109A, MSC2571107A), Osimertinib and Its Metabolite AZD5104
timeFrame: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after tepotinib and Osimertinib administration at Day 1 of Cycle 1 and Day 15 of Cycle 1 (each Cycle is of 21 days) ]
measure: Percentage of Participants With Resistant Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene or Other Pathways as Assessed in Circulating Tumor Deoxyribonucleic Acid (ctDNA)
timeFrame: From Day 1 of Cycle 3 up to end of treatment (14 days after last dose, approximately assessed up to 35.6 months) (each Cycle is for 21 days)
Other outcomes:
Locations:
city: Yuma
country: United States
facility: Yuma Regional Medical Center
state: Arizona
city: Fountain Valley
country: United States
facility: Compassionate Care Research Group Inc - Edinger Medical Group, Inc.
state: California
city: Long Beach
country: United States
facility: Memorial Care
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology Oncology Specialists
state: California
city: Whittier
country: United States
facility: Innovative Clinical Research Institute
state: California
city: Norwich
country: United States
facility: Eastern Connecticut Hematology & Oncology Associates
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Holy Cross
state: Florida
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology
state: Florida
city: Athens
country: United States
facility: University Cancer and Blood Center
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Cancer Care
state: Hawaii
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology
state: Indiana
city: Indianapolis
country: United States
facility: Community Health Network
state: Indiana
city: South Bend
country: United States
facility: Beacon Health
state: Indiana
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Hammond
country: United States
facility: Pontchartrain
state: Louisiana
city: Baltimore
country: United States
facility: Medstar Franklin Square Clinical Research Center
state: Maryland
city: Bethesda
country: United States
facility: The Center for Cancer & Blood Disorders - Maryland
state: Maryland
city: Frederick
country: United States
facility: Frederick Health- James M Stockman Cancer Institute
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center - Dept. Hematology/Oncology
state: Massachusetts
city: Fairhaven
country: United States
facility: Southcoast Center for Cancer Care
state: Massachusetts
city: Lansing
country: United States
facility: Sparrow Hospital Herbert - Herman Cancer Center
state: Michigan
city: Bolivar
country: United States
facility: Central Care Cancer Center (CCCC)
state: Missouri
city: Bridgeton
country: United States
facility: St. Louis Cancer Care, LLP
state: Missouri
city: Saint Joseph
country: United States
facility: Mosaic Life Care
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Belleville
country: United States
facility: New Jersey Cancer Care and Blood Disorders
state: New Jersey
city: Florham Park
country: United States
facility: Summit Medical Group
state: New Jersey
city: New York
country: United States
facility: NYU Langone Clinical Cancer Center - NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Clinical Cancer Center - NYU Langone Medical Cente
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College - Gastroenterology
state: New York
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Seidman
state: Ohio
city: Columbus
country: United States
facility: OhioHealth
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute
state: Oklahoma
city: Salem
country: United States
facility: Oregon Oncology Specialists
state: Oregon
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Memphis
country: United States
facility: Baptist Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical Oncology
state: Texas
city: Ogden
country: United States
facility: Community Cancer Trials of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Fredericksburg
country: United States
facility: Hematology Oncology Associates of Fredericksburg
state: Virginia
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Edegem
country: Belgium
facility: UZ Antwerpen - Department of Oncology
city: Gasthuisberg
country: Belgium
facility: UZ Leuven
city: Roeselare
country: Belgium
facility: AZ Delta
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University Cancer Hospital
city: Changchun
country: China
facility: Jilin Cancer Hospital - Oncology
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: Affiliated Tumor Hospital of Harbin Medical University
city: Hefei
country: China
facility: Anhui Chest Hospital
city: Linyi
country: China
facility: Linyi Tumor Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Shanghai
country: China
facility: Shanghai Cancer Hospital, Fudan University
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
city: Urumqi
country: China
facility: The Affiliated Cancer Hospital of Xinjiang Medical university
city: Wuhan
country: China
facility: Hubei Cancer Hospital
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
city: Caen Cedex 05
country: France
facility: Centre Francois Baclesse - Service d'Oncologie Medicale
city: Creteil Cedex
country: France
facility: Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie
city: Limoges
country: France
facility: CHU Limoges - Hôpital Dupuytren - Unite d'Oncologie Thoracique et Cutanée
city: Lyon
country: France
facility: Centre Léon Bérard
city: Nord
country: France
facility: Hopital Albert Calmette - CHU Lille - service de pneumologie et immuno allergologie
city: Paris cedex 14
country: France
facility: Hospital Cochin Service, Service de Pneumologie et Mucoviscidose
city: Paris
country: France
facility: Hopital Tenon - service pneumologie
city: Pessac
country: France
facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Larrey - Service de Pneumologie et Oncologie Pneumologique
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus TU Dresden
city: Gauting
country: Germany
facility: Asklepios Fachkliniken Muenchen-Gauting - Abteilung internistische Onkologie
city: Giessen
country: Germany
facility: Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen
city: Göttingen
country: Germany
facility: Universitaetsmedizin Goettingen
city: Hamm
country: Germany
facility: Evangelisches Krankenhaus Hamm gGmbH
city: Hamm
country: Germany
facility: Evangelisches Krankenhaus Hamm GmbH
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH
city: Kiel
country: Germany
facility: Staedtisches Krankenhaus Kiel
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln - Innere Medizin I, Onkologie, Haematologie
city: Leipzig
country: Germany
facility: POIS Leipzig GbR
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
city: Oldenburg
country: Germany
facility: Pius-Hospital Oldenburg - Klinik f. Haematologie und Onkologie
city: Wuerzburg
country: Germany
facility: Missionsärztliche Klinik
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital - Department of Medicine
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
city: Shatin
country: Hong Kong
facility: The Chinese University of Hong Kong - Emergency Medicine
city: Lazio
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
city: Milano
country: Italy
facility: IEO Istituto Europeo di Oncologia
city: Monza
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo) - U.O Oncologia Medica
city: Napoli
country: Italy
facility: Ospedale Monaldi
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2
city: Palermo
country: Italy
facility: AO Ospedali Riuniti Cervello - Presidio Villa Sofia - U.O.S. di Neuroimmunologia
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - U.O. Pneumologia II
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena IRCCS - S.C. Oncologia Medica B
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Varese
country: Italy
facility: Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi) - Oncologia Medica
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - U.O.C. Oncologia
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University School of Medicine, University Hospital - Dept of Respiratory Medicine
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital - Dept of Respiratory Medicine
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital - Dept of Internal Medicine
city: Nishinomiya-shi
country: Japan
facility: Hyogo College of Medicine Hospital - Dept of Respiratory Medicine
city: Okayama-shi
country: Japan
facility: Okayama University Hospital - Dept of Respiratory Medicine/Allergy
city: Osaka-shi
country: Japan
facility: Osaka City General Hospital
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
city: Ube-shi
country: Japan
facility: NHO Yamaguchi - Ube Medical Center
city: Yokohama-shi
country: Japan
facility: Kanagawa Cancer Center - Dept of Respiratory Medicine
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Kuala Lumpur
country: Malaysia
facility: Pantai Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
city: Petaling Jaya, Selangor
country: Malaysia
facility: Sunway Medical Centre
city: Pulau Pinang
country: Malaysia
facility: Hospital Pulau Pinang - Clinic Respiratory
city: Selangor
country: Malaysia
facility: Beacon International Specialist Centre Sdn Bhd
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen - Department of Internal Medicine
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center - Dept of Medical Oncology
city: Krasnoyarsk
country: Russian Federation
facility: SBHI "Krasnoyarsk Regional Oncology Dispensary n.a. A.I. Kryzhanovsky"
city: Moscow
country: Russian Federation
facility: "VitaMed" LLC
city: Nizniy Novgorod
country: Russian Federation
facility: LLC "Tonus"
city: Omsk
country: Russian Federation
facility: BHI of Omsk region "Clinical Oncology Dispensary"
city: Pyatigorsk
country: Russian Federation
facility: LLC "ClinicaUZI4D"
city: Saint-Petersburg
country: Russian Federation
facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
city: St. Petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University - Research Institute of Pulmunology
city: Connexion
country: Singapore
facility: Icon Cancer Centre
city: Singapore
country: Singapore
facility: National Cancer Centre - Medical Oncology Pharmacy
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital - CTRU/OCS, Research
city: Badalona
country: Spain
facility: ICO Badalona - Hospital Germans Trias i Pujol - Servicio de Oncologia Medica
city: Barcelona
country: Spain
facility: Hospital del Mar - Servicio de Oncologia
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus - Servicio de Oncologia Medica
city: Barcelona
country: Spain
facility: Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron - Dept of Oncology
city: L'Hospitalet de Llobregat
country: Spain
facility: ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Materno-Infantil de Canarias - Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Palma
country: Spain
facility: Hospital Universitari Son Espases - Servicio de Oncologia Medica
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quiron Madrid - Unidad Integral de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena - Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center, Liou Ying
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital
city: Hat Yai
country: Thailand
facility: Songklanagarind Hospital
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Pathumwan
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Hanoi
country: Vietnam
facility: Bach Mai Hospital
city: Hanoi
country: Vietnam
facility: K Hospital
city: Hanoi
country: Vietnam
facility: National Lungs Hospital
city: Ho Chi Minh City
country: Vietnam
facility: Cho Ray Hospital
city: Ho Chi Minh city
country: Vietnam
facility: HCMC Oncology Hospital
city: Ho Chi Minh City
country: Vietnam
facility: Pham Ngoc Thach Hospital
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: F Smit E, Dooms C, Raskin J, Nadal E, Tho LM, Le X, Mazieres J, S Hin H, Morise M, W Zhu V, Tan D, H Holmberg K, Ellers-Lenz B, Adrian S, Brutlach S, Schumacher KM, Karachaliou N, Wu YL. INSIGHT 2: a phase II study of tepotinib plus osimertinib in MET-amplified NSCLC and first-line osimertinib resistance. Future Oncol. 2022 Mar;18(9):1039-1054. doi: 10.2217/fon-2021-1406. Epub 2021 Dec 17.