A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tepotinib and Osimertinib Participants will receive a combination of tepotinib and osimertinib. The combination will be applied in cycles of 21 days until disease progression, death, adverse event leading to discontinuation, study withdrawal or consent withdrawal. |
Drug: Tepotinib
Participants will be administered Tepotinib orally once daily at an initial dose of 500 milligram (mg). A safety monitoring committee (SMC) may decide to confirm or adapt the dose.
Drug: Osimertinib
Participants will receive Osimertinib at a dose of 80 mg orally once daily.
Other Names:
|
| Experimental: Tepotinib Mono-therapy Participants will receive once daily dose of tepotinib. The mono therapy will be applied in cycles of 21 days until disease progression, death, adverse event leading to discontinuation, study withdrawal or consent withdrawal. |
Drug: Tepotinib
Participants will be administered Tepotinib orally once daily at an initial dose of 500 milligram (mg). A safety monitoring committee (SMC) may decide to confirm or adapt the dose.
|
Outcome Measures
Primary Outcome Measures
- Safety run-in: 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) [Up to Day 21 of Cycle 1 (each Cycle is of 21 days)]
- Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1as per Independent Review Committee for Combined Therapy in Participants With MET Amplification Determined Centrally by Fluorescence in situ Hybridization(FISH) [Every 6 weeks following the Cycle 1 Day 1 visit until 9 months; every 12 weeks thereafter until disease progression, death, study withdrawal, or withdrawal of consent (each Cycle is of 21 days) (approximately 38 months)]
Participants are identified as having an objective response if they achieve either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progression disease (PD) according to determined according to RECIST 1.1 as adjudicated by the IRC. CR: Complete Response defined as disappearance of all target and non target lesions and any pathological lymph nodes (whether target or non target) must have reduction in short axis to less than (<) 10 mm. Partial response defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. PD defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Secondary Outcome Measures
- Objective Response According to RECIST Version 1.1 as per IRC for Combined Therapy in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing [Every 6 weeks following the Cycle 1 Day 1 visit until 9 months; every 12 weeks thereafter until disease progression, death, study withdrawal, or withdrawal of consent (each Cycle is of 21 days) (approximately 42 months)]
Participants are identified as having an objective response if they achieve either a confirmed CR or PR from first administration of study treatment to first observation of PD according to determined according to RECIST 1.1 as adjudicated by the IRC. CR: Complete Response defined as disappearance of all target and non target lesions and any pathological lymph nodes (whether target or non target) must have reduction in short axis to less than (<) 10 mm. Partial response defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. PD defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
- Objective Response According to RECIST Version 1.1 as per IRC for Tepotinib Monotherapy in Participants With MET Amplification Determined Centrally by FISH [Every 6 weeks following the Cycle 1 Day 1 visit until 9 months; every 12 weeks thereafter until disease progression, death, study withdrawal, or withdrawal of consent (each Cycle is of 21 days) (approximately 42 months)]
Participants are identified as having an objective response if they achieve either a confirmed CR or PR from first administration of study treatment to first observation of PD according to determined according to RECIST 1.1 as adjudicated by the IRC. CR: Complete Response defined as disappearance of all target and non target lesions and any pathological lymph nodes (whether target or non target) must have reduction in short axis to less than (<) 10 mm. Partial response defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. PD defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
- Number of Participants With Adverse Events (AEs) and Treatment-Related Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, and Deaths [Baseline up to 30 days after the last dose of study treatment]
- Percentage of Participants With Abnormal greater Than or Equal to (>=) Grade 3 Laboratory Findings [Baseline up to 30 days after the last dose of study treatment]
- Percentage of Participants With Abnormal Vital Signs, Electrocardiograms (ECGs) and Eastern Cooperative Oncology Group (ECOG) Performance Status [Baseline up to 30 days after the last dose of study treatment]
Percentage of participants with abnormalities in vital signs; clinically significant electrocardiograms (ECGs), change in body weight and change in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) will be analyzed.
- Objective Response According to RECIST Version 1.1 Assessed by Investigator for Combined Therapy in Participants with MET Amplification Determined Centrally by FISH [Every 6 weeks following the Cycle 1 Day 1 visit until 9 months; every 12 weeks thereafter until disease progression, death, study withdrawal, or withdrawal of consent (each Cycle is of 21 days) (approximately 42 months)]
Participants are identified as having an objective response if they achieve either a confirmed CR or PR from first administration of study treatment to first observation of PD according to RECIST 1.1 as adjudicated by the Investigator. CR: CR defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. PD defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started.
- Confirmed Complete Response Assessed by IRC and by Investigator for Combined Therapy in Participants with MET Amplification Determined Centrally by FISH [Every 6 weeks following the Cycle 1 Day 1 visit until 9 months; every 12 weeks thereafter until disease progression, death, study withdrawal, or withdrawal of consent (each Cycle is of 21 days) (approximately 42 months)]
Complete Response (CR) defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non target) must have reduction in short axis to < 10 mm. Participants will be assessed who have confirmed CR if they achieve a confirmed CR from first administration of study treatment to first observation of PD. Participants are identified as having a confirmed CR if they achieve a confirmed CR from first administration of study treatment to first observation of PD.
- Duration of Response Assessed by Independent Review Committee (IRC) and by Investigator for Combined Therapy in Participants with MET Amplification Determined Centrally by FISH [Approximately 42 months]
Duration of response is the time from when the CR/PR (whichever is first) criteria are first met until PD or death due to any cause of the last tumor assessment, whichever occurs first.
- Percentage of Participants With Disease Control Assessed by IRC and by Investigator for Combined Therapy in Participants with MET Amplification Determined Centrally by FISH [Approximately 42 months]
Participants are identified as having objective disease control if they achieve either a confirmed CR or PR (confirmation needs to take place after the tumor assessments initially indicating CR or PR), or stable disease (SD).
- Progression-Free Survival Assessed by the IRC and Investigator for Combined Therapy According to RECIST v1.1 in Participants with MET Amplification Determined Centrally by FISH [Approximately 42 months]
Progression free survival is defined as the time (in months) from first administration of study treatment to the date of the first documentation of PD or death due to any cause of the last tumor assessment, whichever occurs first.
- Overall Survival for Combined Therapy in Participants With MET Amplification Determined Centrally by FISH [Approximately 42 months]
Overall survival is defined as the time (in months) from first administration of study treatment to the date of death.
- Objective Response Assessed by Investigator According to RECIST v1.1 for Tepotinib Monotherapy in Participants with MET Amplification Determined Centrally by FISH [Every 6 weeks following the Cycle 1 Day 1 visit until 9 months; every 12 weeks thereafter until disease progression, death, study withdrawal, or withdrawal of consent (each Cycle is of 21 days) (approximately 42 months)]
Participants are identified as having an objective response if they achieve either a confirmed CR or PR from first administration of study treatment to first observation of PD according to RECIST 1.1 as adjudicated by the Investigator. CR: CR defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. PD defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started.
- Confirmed Complete Response Assessed by IRC and by Investigator for Tepotinib Monotherapy in Participants With MET Amplification Determined Centrally by FISH [Every 6 weeks following the Cycle 1 Day 1 visit until 9 months; every 12 weeks thereafter until disease progression, death, study withdrawal, or withdrawal of consent (each Cycle is of 21 days) (approximately 42 months)]
Complete Response (CR) defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non target) must have reduction in short axis to < 10 mm. Participants will be assessed who have confirmed CR if they achieve a confirmed CR from first administration of study treatment to first observation of PD. Participants are identified as having a confirmed CR if they achieve a confirmed CR from first administration of study treatment to first observation of PD.
- Duration of Response Assessed by IRC and by Investigator for Tepotinib Monotherapy in Participants with MET Amplification Determined Centrally by FISH [Approximately 42 months]
Duration of response is the time from when the CR/PR (whichever is first) criteria are first met until PD or death due to any cause of the last tumor assessment, whichever occurs first.
- Percentage of Participants With Disease Control Assessed by IRC and Investigator for Tepotinib Monotherapy in Participants with MET Amplification Determined Centrally by FISH [Approximately 42 months]
Participants are identified as having objective disease control if they achieve either a confirmed CR or PR (confirmation needs to take place after the tumor assessments initially indicating CR or PR), or stable disease (SD).
- Progression-Free Survival Assessed by the IRC and Investigator for Tepotinib Monotherapy According to RECIST v1.1 in Participants with MET Amplification Determined Centrally by FISH [Approximately 42 months]
Progression free survival is defined as the time (in months) from first administration of study treatment to the date of the first documentation of PD or death due to any cause of the last tumor assessment, whichever occurs first.
- Health-Related Quality of Life as Assessed by EuroQol Five Dimension Five Level (EQ-5D-5L) Scale Score in Combination Therapy [Approximately 42 months]
- Health-Related Quality of Life as assessed by European Organisation For Research And Treatment of Cancer Quality of Life Questionnaire Core 3D (EORTC-QLQ-C30) in Combination Therapy [Every 6 weeks following the Cycle 1 Day 1 visit until 9 months; every 12 weeks thereafter until disease progression, death, study withdrawal, or withdrawal of consent (each Cycle is of 21 days) (approximately 42 months)]
- Health-Related Quality of Life as assessed by Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) in Combination Therapy [Every 6 weeks following the Cycle 1 Day 1 visit until 9 months; every 12 weeks thereafter until disease progression, death, study withdrawal, or withdrawal of consent (each Cycle is of 21 days) (approximately 42 months)]
- Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of Tepotinib and Osimertinib and Their Metabolities [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)]
- Maximum Observed Plasma Concentration (Cmax) of Tepotinib and Osimertinib and Their Metabolities [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)]
- Time to Reach Maximum Observed Plasma Concentration (tmax) of Tepotinib and Osimertinib and Their Metabolities [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)]
- Apparent Total Body Clearance (CL/f) of Tepotinib and Osimertinib and Their Metabolities [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)]
The apparent total body clearance of study intervention following extravascular administration, taking into account the fraction of dose absorbed. CL/f = Dose p.o. /AUC0-infinity (AUC0-inf).
- Apparent Volume Of Distribution (Vz/F) of Tepotinib and Osimertinib and Their Metabolities [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)]
The apparent volume of distribution during the terminal phase following extravascular administration, based on the fraction of dose absorbed. The Vz/f was calculated by dividing the dose with area under the concentration time curve from time zero to infinity multiplied with terminal elimination rate constant Lambda(z). Vz/f=Dose/AUC(0-inf)* Lambda(z).
- 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 [From Day 1 of Cycle 3 up to end of treatment (14 days after last dose) (each Cycle is for 21 days)]
Eligibility Criteria
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
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yuma Regional Medical Center | Yuma | Arizona | United States | 85364 |
| 2 | Compassionate Care Research Group Inc - Edinger Medical Group, Inc. | Fountain Valley | California | United States | 92708 |
| 3 | Memorial Care | Long Beach | California | United States | 90806 |
| 4 | Chao Family Clinical Research Center - RC for Dr. Kenneth Chang | Orange | California | United States | 92868 |
| 5 | Ventura County Hematology Oncology Specialists | Oxnard | California | United States | 93030 |
| 6 | Innovative Clinical Research Institute | Whittier | California | United States | 92801 |
| 7 | Eastern Connecticut Hematology & Oncology Associates | Norwich | Connecticut | United States | 06360 |
| 8 | Holy Cross | Fort Lauderdale | Florida | United States | 33308 |
| 9 | Memorial Healthcare System | Hollywood | Florida | United States | 33021 |
| 10 | Cancer Specialists of North Florida | Jacksonville | Florida | United States | 32256 |
| 11 | University of Miami Miller School of Medicine | Miami | Florida | United States | 33136 |
| 12 | Ocala Oncology | Ocala | Florida | United States | 34474 |
| 13 | University Cancer and Blood Center | Athens | Georgia | United States | 30607 |
| 14 | Hawaii Cancer Care | Honolulu | Hawaii | United States | 96813 |
| 15 | University of Chicago Medical Center | Chicago | Illinois | United States | 60637 |
| 16 | Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | United States | 46845 |
| 17 | Community Health Network | Indianapolis | Indiana | United States | 46250 |
| 18 | Beacon Health | South Bend | Indiana | United States | 46601 |
| 19 | Norton Cancer Institute | Louisville | Kentucky | United States | 40202 |
| 20 | Pontchartrain | Hammond | Louisiana | United States | 70433 |
| 21 | Medstar Franklin Square Clinical Research Center | Baltimore | Maryland | United States | 21237 |
| 22 | The Center for Cancer & Blood Disorders - Maryland | Bethesda | Maryland | United States | 20817 |
| 23 | Frederick Health- James M Stockman Cancer Institute | Frederick | Maryland | United States | 21702 |
| 24 | Boston Medical Center - Dept. Hematology/Oncology | Boston | Massachusetts | United States | 02118 |
| 25 | Southcoast Center for Cancer Care | Fairhaven | Massachusetts | United States | 02719 |
| 26 | Sparrow Hospital Herbert - Herman Cancer Center | Lansing | Michigan | United States | 48912 |
| 27 | Central Care Cancer Center (CCCC) | Bolivar | Missouri | United States | 65613 |
| 28 | St. Louis Cancer Care, LLP | Bridgeton | Missouri | United States | 63044 |
| 29 | Mosaic Life Care | Saint Joseph | Missouri | United States | 64507 |
| 30 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89169 |
| 31 | New Jersey Cancer Care and Blood Disorders | Belleville | New Jersey | United States | 07109 |
| 32 | Summit Medical Group | Florham Park | New Jersey | United States | 07932 |
| 33 | NYU Langone Clinical Cancer Center - NYU Langone Medical Center | New York | New York | United States | 10016 |
| 34 | NYU Langone Clinical Cancer Center - NYU Langone Medical Cente | New York | New York | United States | 10016 |
| 35 | Weill Cornell Medical College - Gastroenterology | New York | New York | United States | 10021 |
| 36 | Southeastern Medical Oncology Center | Goldsboro | North Carolina | United States | 27534 |
| 37 | University Hospitals Seidman | Cleveland | Ohio | United States | 44106 |
| 38 | OhioHealth | Columbus | Ohio | United States | 43214 |
| 39 | Oklahoma Cancer Specialists and Research Institute | Tulsa | Oklahoma | United States | 74146 |
| 40 | Oregon Oncology Specialists | Salem | Oregon | United States | 97301 |
| 41 | Gettysburg Cancer Center | Gettysburg | Pennsylvania | United States | 17325 |
| 42 | Sanford Health | Sioux Falls | South Dakota | United States | 57104 |
| 43 | Avera Cancer Institute | Sioux Falls | South Dakota | United States | 57108 |
| 44 | Baptist Cancer Center | Memphis | Tennessee | United States | 38120 |
| 45 | Tennessee Oncology | Nashville | Tennessee | United States | 37201 |
| 46 | Mary Crowley Cancer Research | Dallas | Texas | United States | 75230 |
| 47 | University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical Oncology | Houston | Texas | United States | 77030 |
| 48 | Community Cancer Trials of Utah | Ogden | Utah | United States | 84405 |
| 49 | Utah Cancer Specialists | Salt Lake City | Utah | United States | 84106 |
| 50 | Hematology Oncology Associates of Fredericksburg | Fredericksburg | Virginia | United States | 22408 |
| 51 | Northwest Medical Specialties | Tacoma | Washington | United States | 98405 |
| 52 | Medical College of Wisconsin - Froedtert Hospital | Milwaukee | Wisconsin | United States | 53226-3596 |
| 53 | UZ Antwerpen - Department of Oncology | Edegem | Belgium | ||
| 54 | UZ Leuven | Gasthuisberg | Belgium | ||
| 55 | AZ Delta | Roeselare | Belgium | ||
| 56 | Beijing Hospital | Beijing | China | ||
| 57 | Peking Union Medical College Hospital | Beijing | China | ||
| 58 | Peking University Cancer Hospital | Beijing | China | ||
| 59 | Peking University Cancer Hospital | Beijing | China | ||
| 60 | Jilin Cancer Hospital - Oncology | Changchun | China | ||
| 61 | The First Hospital of Jilin University | Changchun | China | ||
| 62 | Hunan Cancer Hospital | Changsha | China | ||
| 63 | West China Hospital, Sichuan University | Chengdu | China | ||
| 64 | Fujian Cancer Hospital | Fuzhou | China | ||
| 65 | Guangdong General Hospital | Guangzhou | China | ||
| 66 | The First Affiliated Hospital, Zhejiang University | Hangzhou | China | ||
| 67 | Zhejiang Cancer Hospital | Hangzhou | China | ||
| 68 | Affiliated Tumor Hospital of Harbin Medical University | Harbin | China | ||
| 69 | Linyi Tumor Hospital | Linyi | China | ||
| 70 | Jiangsu Province Hospital | Nanjing | China | ||
| 71 | Shanghai Cancer Hospital, Fudan University | Shanghai | China | ||
| 72 | Shanghai Chest Hospital | Shanghai | China | ||
| 73 | Liaoning Cancer Hospital & Institute | Shenyang | China | ||
| 74 | The Affiliated Cancer Hospital of Xinjiang Medical university | Urumqi | China | ||
| 75 | Hubei Cancer Hospital | Wuhan | China | ||
| 76 | Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | China | ||
| 77 | Centre Francois Baclesse - Service d'Oncologie Medicale | Caen Cedex 05 | France | ||
| 78 | Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie | Creteil Cedex | France | ||
| 79 | CHU Limoges - Hôpital Dupuytren - Unite d'Oncologie Thoracique et Cutanée | Limoges | France | ||
| 80 | Centre Léon Bérard | Lyon | France | ||
| 81 | Hopital Albert Calmette - CHU Lille - service de pneumologie et immuno allergologie | Nord | France | ||
| 82 | Hospital Cochin Service, Service de Pneumologie et Mucoviscidose | Paris cedex 14 | France | ||
| 83 | Hopital Tenon - service pneumologie | Paris | France | ||
| 84 | Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha | Pessac | France | ||
| 85 | CHU de Toulouse - Hôpital Larrey - Service de Pneumologie et Oncologie Pneumologique | Toulouse | France | ||
| 86 | Universitaetsklinikum Carl Gustav Carus TU Dresden | Dresden | Germany | ||
| 87 | Asklepios Fachkliniken Muenchen-Gauting - Abteilung internistische Onkologie | Gauting | Germany | ||
| 88 | Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen | Giessen | Germany | ||
| 89 | Universitaetsmedizin Goettingen | Göttingen | Germany | ||
| 90 | Evangelisches Krankenhaus Hamm gGmbH | Hamm | Germany | ||
| 91 | Evangelisches Krankenhaus Hamm GmbH | Hamm | Germany | ||
| 92 | Thoraxklinik-Heidelberg gGmbH | Heidelberg | Germany | ||
| 93 | Staedtisches Krankenhaus Kiel | Kiel | Germany | ||
| 94 | Universitaetsklinikum Koeln - Innere Medizin I, Onkologie, Haematologie | Koeln | Germany | ||
| 95 | POIS Leipzig GbR | Leipzig | Germany | ||
| 96 | Universitaetsklinikum Schleswig-Holstein - Campus Luebeck | Luebeck | Germany | ||
| 97 | Pius-Hospital Oldenburg - Klinik f. Haematologie und Onkologie | Oldenburg | Germany | ||
| 98 | Missionsärztliche Klinik | Wuerzburg | Germany | ||
| 99 | Queen Elizabeth Hospital - Department of Medicine | Hong Kong | Hong Kong | ||
| 100 | The University of Hong Kong | Hong Kong | Hong Kong | ||
| 101 | The Chinese University of Hong Kong - Emergency Medicine | Shatin | Hong Kong | ||
| 102 | IEO Istituto Europeo di Oncologia | Milano | Italy | ||
| 103 | Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo) - U.O Oncologia Medica | Monza | Italy | ||
| 104 | Ospedale Monaldi | Napoli | Italy | ||
| 105 | IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2 | Padova | Italy | ||
| 106 | AO Ospedali Riuniti Cervello - Presidio Villa Sofia - U.O.S. di Neuroimmunologia | Palermo | Italy | ||
| 107 | Azienda Ospedaliero Universitaria Pisana - U.O. Pneumologia II | Pisa | Italy | ||
| 108 | Istituto Clinico Humanitas | Rozzano | Italy | ||
| 109 | Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi) - Oncologia Medica | Varese | Italy | ||
| 110 | Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - U.O.C. Oncologia | Verona | Italy | ||
| 111 | Hamamatsu University School of Medicine, University Hospital - Dept of Respiratory Medicine | Hamamatsu-shi | Japan | ||
| 112 | Saitama Cancer Center | Kitaadachi-gun | Japan | ||
| 113 | Kurume University Hospital | Kurume-shi | Japan | ||
| 114 | Nagoya University Hospital - Dept of Respiratory Medicine | Nagoya-shi | Japan | ||
| 115 | Niigata Cancer Center Hospital - Dept of Internal Medicine | Niigata-shi | Japan | ||
| 116 | Hyogo College of Medicine Hospital - Dept of Respiratory Medicine | Nishinomiya-shi | Japan | ||
| 117 | Okayama University Hospital - Dept of Respiratory Medicine/Allergy | Okayama-shi | Japan | ||
| 118 | Osaka City General Hospital | Osaka-shi | Japan | ||
| 119 | Kindai University Hospital | Osakasayama-shi | Japan | ||
| 120 | NHO Yamaguchi - Ube Medical Center | Ube-shi | Japan | ||
| 121 | Kanagawa Cancer Center - Dept of Respiratory Medicine | Yokohama-shi | Japan | ||
| 122 | National Cancer Center | Goyang-si | Korea, Republic of | ||
| 123 | Chonnam National University Hwasun Hospital | Hwasun-gun | Korea, Republic of | ||
| 124 | Seoul National University Bundang Hospital | Seongnam-si | Korea, Republic of | ||
| 125 | Asan Medical Center | Seoul | Korea, Republic of | ||
| 126 | Korea University Anam Hospital | Seoul | Korea, Republic of | ||
| 127 | Samsung Medical Center | Seoul | Korea, Republic of | ||
| 128 | Seoul National University Hospital | Seoul | Korea, Republic of | ||
| 129 | The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | Korea, Republic of | ||
| 130 | Ulsan University Hospital | Ulsan | Korea, Republic of | ||
| 131 | Pantai Hospital Kuala Lumpur | Kuala Lumpur | Malaysia | ||
| 132 | University Malaya Medical Centre | Kuala Lumpur | Malaysia | ||
| 133 | Hospital Tengku Ampuan Afzan | Kuantan | Malaysia | ||
| 134 | Hospital Umum Sarawak | Kuching | Malaysia | ||
| 135 | Sunway Medical Centre | Petaling Jaya, Selangor | Malaysia | ||
| 136 | Hospital Pulau Pinang - Clinic Respiratory | Pulau Pinang | Malaysia | ||
| 137 | Beacon International Specialist Centre Sdn Bhd | Selangor | Malaysia | ||
| 138 | The Netherlands Cancer Institute | Amsterdam | Netherlands | ||
| 139 | Universitair Medisch Centrum Groningen - Department of Internal Medicine | Groningen | Netherlands | ||
| 140 | Maastricht University Medical Center - Dept of Medical Oncology | Maastricht | Netherlands | ||
| 141 | SBHI "Krasnoyarsk Regional Oncology Dispensary n.a. A.I. Kryzhanovsky" | Krasnoyarsk | Russian Federation | ||
| 142 | "VitaMed" LLC | Moscow | Russian Federation | ||
| 143 | LLC "Tonus" | Nizniy Novgorod | Russian Federation | ||
| 144 | BHI of Omsk region "Clinical Oncology Dispensary" | Omsk | Russian Federation | ||
| 145 | LLC "ClinicaUZI4D" | Pyatigorsk | Russian Federation | ||
| 146 | FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov" | Saint-Petersburg | Russian Federation | ||
| 147 | Pavlov First Saint Petersburg State Medical University - Research Institute of Pulmunology | St. Petersburg | Russian Federation | ||
| 148 | Icon Cancer Centre | Connexion | Singapore | ||
| 149 | National Cancer Centre - Medical Oncology Pharmacy | Singapore | Singapore | ||
| 150 | Tan Tock Seng Hospital - CTRU/OCS, Research | Singapore | Singapore | ||
| 151 | ICO Badalona - Hospital Germans Trias i Pujol - Servicio de Oncologia Medica | Badalona | Spain | ||
| 152 | Hospital del Mar - Servicio de Oncologia | Barcelona | Spain | ||
| 153 | Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica | Barcelona | Spain | ||
| 154 | Hospital Universitari Vall d'Hebron - Dept of Oncology | Barcelona | Spain | ||
| 155 | ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia | L'Hospitalet de Llobregat | Spain | ||
| 156 | Hospital Universitario Materno-Infantil de Canarias - Servicio de Oncologia | Las Palmas de Gran Canaria | Spain | ||
| 157 | Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia | Madrid | Spain | ||
| 158 | Hospital Regional Universitario de Malaga | Málaga | Spain | ||
| 159 | Hospital Universitari Son Espases - Servicio de Oncologia Medica | Palma | Spain | ||
| 160 | Hospital Universitario Quiron Madrid - Unidad Integral de Oncologia | Pozuelo de Alarcon | Spain | ||
| 161 | Hospital Universitario Virgen Macarena - Servicio de Oncologia | Sevilla | Spain | ||
| 162 | Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica | Valencia | Spain | ||
| 163 | Kaohsiung Chang Gung Memorial Hospital | Kaohsiung | Taiwan | ||
| 164 | China Medical University Hospital | Taichung | Taiwan | ||
| 165 | Taichung Veterans General Hospital | Taichung | Taiwan | ||
| 166 | Chi Mei Medical Center, Liou Ying | Tainan | Taiwan | ||
| 167 | National Taiwan University Hospital | Taipei | Taiwan | ||
| 168 | Taipei Veterans General Hospital | Taipei | Taiwan | ||
| 169 | Tri-Service General Hospital | Taipei | Taiwan | ||
| 170 | Siriraj Hospital | Bangkoknoi | Thailand | ||
| 171 | Songklanagarind Hospital | Hat Yai | Thailand | ||
| 172 | Maharaj Nakorn Chiang Mai Hospital | Muang | Thailand | ||
| 173 | King Chulalongkorn Memorial Hospital | Pathumwan | Thailand | ||
| 174 | Bach Mai Hospital | Hanoi | Vietnam | ||
| 175 | K Hospital | Hanoi | Vietnam | ||
| 176 | National Lungs Hospital | Hanoi | Vietnam | ||
| 177 | Cho Ray Hospital | Ho Chi Minh City | Vietnam | ||
| 178 | HCMC Oncology Hospital | Ho Chi Minh city | Vietnam | ||
| 179 | Pham Ngoc Thach Hospital | Ho Chi Minh City | Vietnam |
Sponsors and Collaborators
- EMD Serono Research & Development Institute, Inc.
- Merck KGaA, Darmstadt, Germany
Investigators
- Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Trial Awareness and Transparency website
- US Medical Information website, Medical Resources
- Targeting MET Clinical Trial Program
Publications
None provided.- MS200095_0031
- 2019-001538-33