Clinical trial NCT04685135: Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
Official title: A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Metastatic Non Small Cell Lung Cancer
Advanced Non Small Cell Lung Cancer
Keywords: KRAS G12C
Non-small cell lung cancer
NSCLC
Metastatic Cancer
Docetaxel
Phase 3 Clinical Trial
Adagrasib
KRAS
KRAZATI
Lead sponsor: Mirati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-28
Enrollment: 453
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.
* Candidacy to receive treatment with docetaxel.

Crossover Inclusion Criteria:

* Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR
* ECOG performance status 0-2

Exclusion Criteria:

* Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib).
* Active brain metastases.

Crossover Exclusion Criteria:

* Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.

Primary outcomes:
measure: Progression-Free Survival (PFS) as Per Blinded Independent Central Review
timeFrame: From randomization to the date of progression or death due to any cause, whichever occurs first (up to approximately 143 weeks)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization till death due to any cause (up to approximately 143 weeks)
measure: Objective Response Rate (ORR) as Per Blinded Independent Central Review
timeFrame: From randomization till death or till disease progression or initiation of follow-up anti-cancer therapy or withdrawal of consent prior to minimum efficacy follow-up (up to 143 weeks)
measure: Duration of Response (DOR) as Per Blinded Independent Central Review
timeFrame: First documentation of objective response (CR or PR) to the first documentation of PD or to death due to any cause (Up to approximately 22 months)
measure: 1-Year Survival Rate
timeFrame: Up to 49 months
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)
measure: Number of Participants With Maximum CTCAE Grade Laboratory Abnormality in Hematology Parameters
timeFrame: From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)
measure: Number of Participants With Maximum CTCAE Grade Laboratory Abnormality in Chemistry Parameters
timeFrame: From first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks)
measure: Plasma Concentration of Adagrasib
timeFrame: Day 1 of Cycle 1 (Pre-Dose and Peak), Cycle 2 (Pre-Dose and Peak), Cycle 3 (Pre-Dose), Cycle 5 (Pre-Dose), Cycle 7 (Pre-Dose) (Each cycle is of 21 days)
measure: Change From Baseline in Lung Cancer Symptom Scale (LCSS) Average Total Score
timeFrame: Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
measure: Change From Baseline in Lung Cancer Symptom Scale (LCSS) Average Symptom Burden Index Score
timeFrame: Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
measure: Change From Baseline in Lung Cancer Symptom Scale (LCSS) 3-Item Global Index Score
timeFrame: Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
measure: Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Visual Analogue Scale Score
timeFrame: Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
measure: Change From Baseline at End of Treatment in European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L) Health Utility Index Score
timeFrame: Baseline (Day 1) and up to End of Treatment (Up to approximately 106 weeks)
Other outcomes:
Locations:
city: Cerritos
country: United States
facility: Local Institution - 012-898
state: California
city: Duarte
country: United States
facility: City of Hope - Duarte (Main Campus)
state: California
city: Glendale
country: United States
facility: Local Institution - 012-898 D
state: California
city: Huntington Beach
country: United States
facility: Local Institution - 012-910-A
state: California
city: Irvine
country: United States
facility: Local Institution - 012-910-C
state: California
city: Long Beach
country: United States
facility: City Of Hope
state: California
city: Long Beach
country: United States
facility: Local Institution - 012-910-F
state: California
city: Newport Beach
country: United States
facility: Local Institution - 012-910-D
state: California
city: Santa Ana
country: United States
facility: Local Institution - 012-898 C
state: California
city: Santa Rosa
country: United States
facility: Providence Medical Group - Santa Rosa
state: California
city: Torrance
country: United States
facility: Local Institution - 012-910-E
state: California
city: Denver
country: United States
facility: Local Institution - 012-951-B
state: Colorado
city: Lafayette
country: United States
facility: SCL Health - Saint Joseph Hospital Cancer Center
state: Colorado
city: Lone Tree
country: United States
facility: Local Institution - 012-872
state: Colorado
city: Wheat Ridge
country: United States
facility: Local Institution - 012-951-A
state: Colorado
city: Fleming Island
country: United States
facility: Local Institution - 012-562-B
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Health Fort Lauderdale - Holy Cross Hospital
state: Florida
city: Jacksonville
country: United States
facility: 21st Century Oncology of Jacksonville - North Lee Street
state: Florida
city: Jacksonville
country: United States
facility: Local Institution - 012-562-D
state: Florida
city: Jacksonville
country: United States
facility: Local Institution - 012-562-E
state: Florida
city: Jacksonville
country: United States
facility: Local Institution - 012-562-A
state: Florida
city: Jacksonville
country: United States
facility: Local Institution - 012-562-C
state: Florida
city: Jacksonville
country: United States
facility: Local Institution - 012-562-F
state: Florida
city: Jacksonville
country: United States
facility: Local Institution - 012-562-G
state: Florida
city: Jacksonville
country: United States
facility: Local Institution - 012-562
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Orlando
country: United States
facility: Orlando Health University of Florida Health Cancer Center - Head and Neck Center
state: Florida
city: Pensacola
country: United States
facility: USOR - Woodlands Medical Specialists
state: Florida
city: Plantation
country: United States
facility: Local Institution - 012-839
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center (UCBC) - Athens
state: Georgia
city: Austell
country: United States
facility: Local Institution - 012-835 - A
state: Georgia
city: Carrollton
country: United States
facility: Local Institution - 012-835 - B
state: Georgia
city: Cartersville
country: United States
facility: Local Institution - 012-835 - C
state: Georgia
city: Douglasville
country: United States
facility: Local Institution - 012-835 - D
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers Wellstar - Marietta
state: Georgia
city: Chicago
country: United States
facility: University of Illinois Hospital & Health Sciences System
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Harvey
country: United States
facility: Local Institution - 012-972 C
state: Illinois
city: New Lenox
country: United States
facility: Local Institution - 012-972 A
state: Illinois
city: Niles
country: United States
facility: Illinois Cancer Specialists - Niles
state: Illinois
city: Orland Park
country: United States
facility: Local Institution - 012-972 B
state: Illinois
city: Goshen
country: United States
facility: Goshen Center for Cancer Care
state: Indiana
city: Indianapolis
country: United States
facility: Local Institution - 012-569
state: Indiana
city: Lafayette
country: United States
facility: Local Institution - 012-569 - B
state: Indiana
city: Lafayette
country: United States
facility: Local Institution - 012-569 - C
state: Indiana
city: Mooresville
country: United States
facility: Local Institution - 012-569 - A
state: Indiana
city: Munster
country: United States
facility: Franciscan Health Munster
state: Indiana
city: Chanute
country: United States
facility: Local Institution - 012-942-B
state: Kansas
city: Dodge City
country: United States
facility: Local Institution - 012-942-C
state: Kansas
city: El Dorado
country: United States
facility: Local Institution - 012-942-D
state: Kansas
city: Independence
country: United States
facility: Local Institution - 012-942-E
state: Kansas
city: Kingman
country: United States
facility: Local Institution - 012-942-F
state: Kansas
city: Liberal
country: United States
facility: Local Institution - 012-942-G
state: Kansas
city: McPherson
country: United States
facility: Local Institution - 012-942-H
state: Kansas
city: Newton
country: United States
facility: Local Institution - 012-942-I
state: Kansas
city: Parsons
country: United States
facility: Local Institution - 012-942-J
state: Kansas
city: Pratt
country: United States
facility: Local Institution - 012-942-K
state: Kansas
city: Salina
country: United States
facility: Local Institution - 012-942-L
state: Kansas
city: Wellington
country: United States
facility: Local Institution - 012-942-M
state: Kansas
city: Westwood
country: United States
facility: Local Institution - 012-820
state: Kansas
city: Wichita
country: United States
facility: Local Institution - 012-942-A
state: Kansas
city: Wichita
country: United States
facility: Local Institution - 012-942
state: Kansas
city: Winfield
country: United States
facility: Local Institution - 012-942-N
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: New Orleans
country: United States
facility: Local Institution - 012-911 A
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Kennebunk
country: United States
facility: Local Institution - 012-954 - A
state: Maine
city: Scarborough
country: United States
facility: New England Cancer Specialists - Scarborough
state: Maine
city: Topsham
country: United States
facility: Local Institution - 012-954 - B
state: Maine
city: Frederick
country: United States
facility: Frederick Health
state: Maryland
city: Novi
country: United States
facility: Local Institution - 012-974-B
state: Michigan
city: Novi
country: United States
facility: Local Institution - 012-974-C
state: Michigan
city: Southfield
country: United States
facility: Ascension Providence Cancer Center - Southfield
state: Michigan
city: Southfield
country: United States
facility: Local Institution - 012-974-A
state: Michigan
city: Bolivar
country: United States
facility: Central Care Cancer Center - Bolivar
state: Missouri
city: Billings
country: United States
facility: Local Institution - 012-841 - A
state: Montana
city: Billings
country: United States
facility: St. Vincent Healthcare Cancer Centers of Montana
state: Montana
city: Billings
country: United States
facility: Sisters of Charity of Leavenworth Health St. Marys
state: Montana
city: East Brunswick
country: United States
facility: Astera Cancer Care - East Brunswick
state: New Jersey
city: Edison
country: United States
facility: Local Institution - 012-975 - A
state: New Jersey
city: Monroe
country: United States
facility: Local Institution - 012-975 - B
state: New Jersey
city: Somerset
country: United States
facility: Local Institution - 012-975 - C
state: New Jersey
city: Somerville
country: United States
facility: Local Institution - 012-975 - D
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Kettering
country: United States
facility: Kettering Health Cancer Center - Main Campus
state: Ohio
city: Salem
country: United States
facility: Oregon Oncology Specialists
state: Oregon
city: Providence
country: United States
facility: Lifespan Cancer Institute - Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: Local Institution - 012-960-A
state: Rhode Island
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Faris Road
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Arlington
country: United States
facility: Texas Oncology - Dallas Fort Worth (DFW) - Arlington Cancer Center North
state: Texas
city: Austin
country: United States
facility: Texas Oncology - Dallas Fort Worth (DFW) - South Austin
state: Texas
city: Irving
country: United States
facility: US Oncology Research (USOR)
state: Texas
city: Sherman
country: United States
facility: Texas Oncology - Sherman
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists - UCS Cancer Center
state: Utah
city: Salt Lake City
country: United States
facility: Local Institution - 012-976-A
state: Utah
city: Salt Lake City
country: United States
facility: Local Institution - 012-976-B
state: Utah
city: Salt Lake City
country: United States
facility: Local Institution - 012-976-C
state: Utah
city: Salt Lake City
country: United States
facility: Local Institution - 012-976-D
state: Utah
city: Salt Lake City
country: United States
facility: Local Institution - 012-976-E
state: Utah
city: Salt Lake City
country: United States
facility: Local Institution - 012-976-F
state: Utah
city: Salt Lake City
country: United States
facility: Local Institution - 012-976-G
state: Utah
city: Salt Lake City
country: United States
facility: Local Institution - 012-976-H
state: Utah
city: Salt Lake City
country: United States
facility: Local Institution - 012-976-I
state: Utah
city: Arlington
country: United States
facility: Local Institution - 012-814 - B
state: Virginia
city: Charlottesville
country: United States
facility: UVA Health - University Hospital
state: Virginia
city: Fairfax
country: United States
facility: Local Institution - 012-814 - A
state: Virginia
city: Fairfax
country: United States
facility: NEXT Virginia
state: Virginia
city: Gainesville
country: United States
facility: Local Institution - 012-814 - C
state: Virginia
city: Leesburg
country: United States
facility: Local Institution - 012-814 - D
state: Virginia
city: Mackay
country: Australia
facility: Local Institution - 012-016
state: Queensland
city: Bedford Park
country: Australia
facility: Local Institution - 012-005
city: Clayton
country: Australia
facility: Local Institution - 012-004
city: Douglas
country: Australia
facility: Townsville University Hospital
city: St. Leonards
country: Australia
facility: Local Institution - 012-013
city: Tweed Heads
country: Australia
facility: Local Institution - 012-019
city: Wollongong
country: Australia
facility: Cancer Care Wollongong
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Klagenfurt Am Woerthersee
country: Austria
facility: Klinikum Klagenfurt Am Worthersee
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg
city: Wien
country: Austria
facility: Wiener Gesundheitsverbund - Klinik Ottakring
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Edegem
country: Belgium
facility: Local Institution - 012-157
city: Gent
country: Belgium
facility: Local Institution - 012-155
city: Gilly
country: Belgium
facility: Local Institution - 012-151
city: Hasselt
country: Belgium
facility: Local Institution - 012-158
city: Roeselare
country: Belgium
facility: Local Institution - 012-152
city: Ronse
country: Belgium
facility: Algemeen Ziekenhuis Glorieux Ronse
city: Yvoir
country: Belgium
facility: Local Institution - 012-150
city: Horovice
country: Czechia
facility: Local Institution - 012-164
city: Olomouc
country: Czechia
facility: Local Institution - 012-162
city: Praha 2
country: Czechia
facility: Vseobecna Fakultni Nemocnice v Praze
city: Praha 8 - Liben
country: Czechia
facility: Fakultni nemocnice Bulovka
city: Pierre Benite
country: France
facility: Local Institution - 012-191-A
state: Rhone-Alpes
city: Lyon
country: France
facility: Local Institution - 012-191-B
state: Rhone
city: Brest
country: France
facility: Local Institution - 012-194
city: Bron
country: France
facility: Hopital Louis Pradel
city: Caen Cedex 09
country: France
facility: Local Institution - 012-193
city: Caen Cedex 5
country: France
facility: Local Institution - 012-196
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal de Creteil
city: Dijon cedex
country: France
facility: Local Institution - 012-192
city: Gleize
country: France
facility: LHopital Nord-Ouest (HNO) - Villefranche-sur-Saone
city: La Tronche
country: France
facility: Hopital Michallon
city: Lille Cedex
country: France
facility: Centre Hospitalier Regional Universitaire de Lille
city: Limoges cedex
country: France
facility: Centre Hospitalier Universitaire Dupuytren 1
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Marseille
country: France
facility: Hopital Nord de Marseille
city: Montpellier
country: France
facility: Hopital Arnaud de Villeneuve
city: Mulhouse
country: France
facility: Hopital Emile Muller
city: Nice Cedex 2
country: France
facility: Local Institution - 012-685
city: Quimper
country: France
facility: Centre Hospitalier de Cornouaille - Hopital Laennec
city: Saint Herblain
country: France
facility: Institut de Cancerologie de lOuest - Saint-Herblain - Site Rene Gauducheau
city: Strasbourg cedex
country: France
facility: Hopital Civil
city: Strasbourg
country: France
facility: Local Institution - 012-197
city: Tours Cedex 9
country: France
facility: Hopital Bretonneau
city: Villejuif
country: France
facility: Gustave Roussy
city: Bad Berka
country: Germany
facility: Local Institution - 012-219
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Essen
country: Germany
facility: Local Institution - 012-210
city: Gauting
country: Germany
facility: Local Institution - 012-214
city: Giessen
country: Germany
facility: Local Institution - 012-671
city: Grohansdorf
country: Germany
facility: LungenClinic Grosshansdorf
city: Halle
country: Germany
facility: Local Institution - 012-215
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: Kassel
country: Germany
facility: Klinikum Kassel
city: Koln
country: Germany
facility: Klinikum Koln-Merheim
city: Lowenstein
country: Germany
facility: Local Institution - 012-224
city: Lubeck
country: Germany
facility: Local Institution - 012-216
city: Munchen
country: Germany
facility: Local Institution - 012-220
city: Offenbach
country: Germany
facility: Local Institution - 012-672
city: Oldenburg
country: Germany
facility: Pius-Hospital Oldenburg
city: Athens
country: Greece
facility: Henry Dunant Hospital Center
state: Attiki
city: Athens
country: Greece
facility: Local Institution - 012-236
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion (PAGNI)
city: Larissa
country: Greece
facility: Local Institution - 012-235
city: Nea Kifisia
country: Greece
facility: "General Oncology Hospital of Kifisias "Agioi Anargyroi""
city: Peiraias
country: Greece
facility: Local Institution - 012-234
city: Peiraias
country: Greece
facility: Metropolitan Hospital
city: Thessaloniki
country: Greece
facility: BioClinic Thessaloniki
city: Thessaloniki
country: Greece
facility: Local Institution - 012-230
city: Thessaloniki
country: Greece
facility: Local Institution - 012-500
city: Volos
country: Greece
facility: Anassa General Clinic
city: Central
country: Hong Kong
facility: Humanity & Health Clinical Trial Centre
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital - Hong Kong
city: Kowloon
country: Hong Kong
facility: Hong Kong United Oncology Centre
city: Budapest
country: Hungary
facility: Local Institution - 012-242
city: Budapest
country: Hungary
facility: Local Institution - 012-244
city: Budapest
country: Hungary
facility: Local Institution - 012-241
city: Gyongyos
country: Hungary
facility: Local Institution - 012-243
city: Gyula
country: Hungary
facility: Local Institution - 012-763
city: Szekesfehervar
country: Hungary
facility: Local Institution - 012-759
city: Torokbalint
country: Hungary
facility: Reformatus Pulmonologiai Centrum
city: Tallaght
country: Ireland
facility: The Meath Foundation
state: Dublin
city: Dublin
country: Ireland
facility: St. Vincents University Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital - Dublin
city: Dublin
country: Ireland
facility: St. Jamess Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Limerick
country: Ireland
facility: University Hospital Limerick
city: Alessandria
country: Italy
facility: Local Institution - 012-276
city: Avellino
country: Italy
facility: Local Institution - 012-292
city: Aviano
country: Italy
facility: Local Institution - 012-274
city: Bari
country: Italy
facility: Local Institution - 012-275
city: Brescia
country: Italy
facility: Local Institution - 012-765
city: Candiolo
country: Italy
facility: Local Institution - 012-286
city: Catania
country: Italy
facility: Local Institution - 012-284
city: Catania
country: Italy
facility: Local Institution - 012-282
city: Firenze
country: Italy
facility: Local Institution - 012-762
city: Genova
country: Italy
facility: Local Institution - 012-273
city: Genova
country: Italy
facility: Local Institution - 012-285
city: Lecce
country: Italy
facility: Local Institution - 012-279
city: Meldola
country: Italy
facility: "Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST"
city: Milano
country: Italy
facility: Local Institution - 012-283
city: Milan
country: Italy
facility: Local Institution - 012-296
city: Milan
country: Italy
facility: Local Institution - 012-278
city: Napoli
country: Italy
facility: Local Institution - 012-271
city: Napoli
country: Italy
facility: Local Institution - 012-277
city: Novara
country: Italy
facility: Local Institution - 012-770
city: Parma
country: Italy
facility: Local Institution - 012-272
city: Perugia
country: Italy
facility: Local Institution - 012-281
city: Pesaro
country: Italy
facility: Local Institution - 012-766
city: Ravenna
country: Italy
facility: Local Institution - 012-767
city: Roma
country: Italy
facility: Local Institution - 012-295
city: Verona
country: Italy
facility: Local Institution - 012-758
city: Busan-si
country: Korea, Republic of
facility: Local Institution - 012-522
city: Busan
country: Korea, Republic of
facility: Local Institution - 012-111
city: Busan
country: Korea, Republic of
facility: Local Institution - 012-101
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Local Institution - 012-110
city: Daegu
country: Korea, Republic of
facility: Local Institution - 012-523
city: Hwasun-gun
country: Korea, Republic of
facility: Local Institution - 012-100
city: Incheon
country: Korea, Republic of
facility: Local Institution - 012-103
city: Jung-Gu
country: Korea, Republic of
facility: Local Institution - 012-102
city: Seongnam-si
country: Korea, Republic of
facility: Local Institution - 012-520
city: Seongnam-si
country: Korea, Republic of
facility: Local Institution - 012-112
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Local Institution - 012-118
city: Seoul
country: Korea, Republic of
facility: Local Institution - 012-106
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea - Seoul St. Marys Hospital
city: Suwon-Si
country: Korea, Republic of
facility: Catholic University of Korea St. Vincents Hospital
city: Suwon-si
country: Korea, Republic of
facility: Local Institution - 012-107
city: Amsterdam
country: Netherlands
facility: Local Institution - 012-306
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis - Breda Molengracht
city: Den Haag
country: Netherlands
facility: Local Institution - 012-308
city: Maastricht
country: Netherlands
facility: Local Institution - 012-300
city: Nijmegen
country: Netherlands
facility: Local Institution - 012-630
city: Utrecht
country: Netherlands
facility: Local Institution - 012-307
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Lodz
country: Poland
facility: Instytut MSF
city: Lublin
country: Poland
facility: Local Institution - 012-321
city: Lublin
country: Poland
facility: Local Institution - 012-760
city: Otwock
country: Poland
facility: Local Institution - 012-325
city: Rzeszow
country: Poland
facility: Local Institution - 012-320
city: Skorzewo
country: Poland
facility: Local Institution - 012-324
city: Torun
country: Poland
facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
city: Warsaw
country: Poland
facility: Wojskowy Instytut Medyczny
city: Warszawa
country: Poland
facility: Local Institution - 012-322
city: Almada
country: Portugal
facility: Unidade Local de Saude de Almada-Seixal, E. P. E (Hospital Garcia de Orta)
city: Braga
country: Portugal
facility: Unidade Local de Saude de Braga, E. P. E (Hospital de Braga)
city: Coimbra
country: Portugal
facility: Local Institution - 012-330
city: Coimbra
country: Portugal
facility: Local Institution - 012-645
city: Guimaraes
country: Portugal
facility: Local Institution - 012-333
city: Lisboa
country: Portugal
facility: Local Institution - 012-338-A
city: Lisbon
country: Portugal
facility: Local Institution - 012-642
city: Lisbon
country: Portugal
facility: The Champalimaud Centre for the Unknown
city: Lisbon
country: Portugal
facility: Local Institution - 012-338
city: Loures
country: Portugal
facility: Unidade Local de Saude de Loures-Odivelas, EPE (Hospital Beatriz Angelo)
city: Porto
country: Portugal
facility: Hospital CUF Porto
city: Porto
country: Portugal
facility: Local Institution - 012-331
city: Porto
country: Portugal
facility: Local Institution - 012-339
city: Santa Maria Da Feira
country: Portugal
facility: Unidade Local de Saude de Entre Douro e Vouga, E. P. E
city: Setubal
country: Portugal
facility: Unidade Local de Saude da Arrabida, E. P. E (Centro Hospitalar de Setubal)
city: Vila Nova de Gaia
country: Portugal
facility: Unidade Local de Saude de Gaia/Espinho, E. P. E
city: San Juan
country: Puerto Rico
facility: Puerto Rico Medical Research Center
city: San Juan
country: Puerto Rico
facility: FDI Clinical Research (Fundacion de Investigacion de Diego) - San Juan
city: San Juan
country: Puerto Rico
facility: PanOncology Trials - Rio Piedras Medical Center
city: Baia Mare
country: Romania
facility: Spitalul Jude�ean de Urgen�a dr. Constantin Opri� Baia Mare
city: Brașov
country: Romania
facility: SC Policlinica de Diagnostic Rapid SA
city: Bucharest
country: Romania
facility: Local Institution - 012-342
city: București
country: Romania
facility: Centrul Oncologic Sanador
city: Cluj-Napoca
country: Romania
facility: Local Institution - 012-344
city: Cluj-Napoca
country: Romania
facility: Local Institution - 012-340
city: Craiova
country: Romania
facility: Oncolab Craiova
city: Craiova
country: Romania
facility: Local Institution - 012-343
city: Iasi
country: Romania
facility: Local Institution - 012-513
city: Ovidiu
country: Romania
facility: Ovidius Clinical Hospital
city: Timisoara
country: Romania
facility: SC OncoMed SRL
city: Timișoara
country: Romania
facility: Oncocenter - Oncologie Clinica
city: Chelyabinsk
country: Russian Federation
facility: Evimed Oncology Clinic
city: Izhevsk
country: Russian Federation
facility: "Budgetary Healthcare Institution of the Udmurt Republic "Republican Clinical Oncological Dispensary n.a. Sergey Grigoryevich Pr
city: Kislino Village
country: Russian Federation
facility: "Regional Budgetary Healthcare Institution "G.E. Ostroverkhov Kursk Oncology Scientific and Clinical Center" of the Healthcare C
city: Moscow
country: Russian Federation
facility: VitaMed - Moscow
city: Moscow
country: Russian Federation
facility: University Headache Clinic
city: Nizhniy Novgorod
country: Russian Federation
facility: State Budgetary Healthcare Institution of the Nizhny Novgorod Region Clinical Diagnostic Center
city: Novosibirsk
country: Russian Federation
facility: "Limited Liability Company Medical Sanitary Unit "Clinicist-Clinic Pretor""
city: Omsk
country: Russian Federation
facility: "Budgetary Healthcare Institution of Omsk region "Clinical Oncologic Dispensary""
city: Saint Petersburg
country: Russian Federation
facility: Local Institution - 012-355
city: Saint Petersburg
country: Russian Federation
facility: Local Institution - 012-354
city: Saint-Petersburg
country: Russian Federation
facility: "Federal State Budgetary Institution "Influenza Research Institute named after N.N. A.A. Smorodintsev" of the Ministry of Health
city: Singapore
country: Singapore
facility: Local Institution - 012-093
city: Singapore
country: Singapore
facility: Raffles Hospital
city: Singapore
country: Singapore
facility: Icon Cancer Centre Farrer Park
city: Singapore
country: Singapore
facility: Oncocare Cancer Centre
city: Singapore
country: Singapore
facility: Parkway Cancer Centre - Gleneagles Hospital
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra - Pamplona
state: Navarre
city: A Coruna
country: Spain
facility: Local Institution - 012-613
city: Alicante
country: Spain
facility: Local Institution - 012-769
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barakaldo
country: Spain
facility: Local Institution - 012-776
city: Barcelona
country: Spain
facility: Hospital del Mar - Parc de Salut Mar
city: Barcelona
country: Spain
facility: Local Institution - 012-614
city: Barcelona
country: Spain
facility: Local Institution - 012-612
city: Barcelona
country: Spain
facility: Local Institution - 012-600
city: Cordoba
country: Spain
facility: Local Institution - 012-621
city: Girona
country: Spain
facility: Local Institution - 012-764
city: Granada
country: Spain
facility: Local Institution - 012-616
city: Las Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular Materno Infantil
city: Leon
country: Spain
facility: Hospital de Leon
city: Lugo
country: Spain
facility: Local Institution - 012-615
city: Madrid
country: Spain
facility: Local Institution - 012-607
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra - Madrid
city: Madrid
country: Spain
facility: Local Institution - 012-606
city: Madrid
country: Spain
facility: Local Institution - 012-601
city: Madrid
country: Spain
facility: Local Institution - 012-609
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Majadahonda
country: Spain
facility: Local Institution - 012-626
city: Malaga
country: Spain
facility: Local Institution - 012-608
city: Palma de Mallorca
country: Spain
facility: Local Institution - 012-602
city: Santander
country: Spain
facility: Local Institution - 012-604
city: Sevilla
country: Spain
facility: Local Institution - 012-629
city: Valencia
country: Spain
facility: Consorci Hospital General Universitari de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Zaragoza
country: Spain
facility: Local Institution - 012-603
city: Basel
country: Switzerland
facility: Universitatsspital Basel
city: Thun
country: Switzerland
facility: Spital Simmental-Thun-Saanenland
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: