Clinical trial NCT04988295: A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure
Official title: A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-08-03
Enrollment: 776
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: The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.


Eligibility criteria: Inclusion Criteria:

* Participant must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated
* Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC), characterized at or after the time of locally advanced or metastatic disease diagnosis by either epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R mutation
* A participant with a history of brain metastases must have had all lesions treated as clinically indicated (that is, no current indication for further definitive local therapy). Any definitive local therapy to brain metastases must have been completed at least 14 days prior to randomization and the participant can be receiving no greater than10 milligrams (mg) prednisone or equivalent daily for the treatment of intracranial disease
* Participant must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
* Any toxicities from prior systemic anticancer therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia \[any grade\], Grade \<= 2 peripheral neuropathy, or Grade \<= 2 hypothyroidism stable on hormone replacement)
* A participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
* Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second- line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Participants who received either neoadjuvant and/or adjuvant treatment of any type are eligible if progression to locally advanced or metastatic disease occurred at least 12 months after the last dose of such therapy and then the participant progressed on or after osimertinib in the locally advanced or metastatic setting. Treatment with osimertinib must be discontinued at least 8 days (4 half-lives) prior to randomization (that is last dose no later than Day -8)

Exclusion Criteria:

* Participant received radiotherapy for palliative treatment of NSCLC less than 14 days prior to randomization
* Participant with symptomatic or progressive brain metastases
* Participant has history of or current evidence of leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation
* Participant has known small cell transformation
* Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
* Participant has a history of clinically significant cardiovascular disease including, but not limited to diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to randomization; myocardial infarction; unstable angina; stroke; transient ischemic attack; coronary/peripheral artery bypass graft; or acute coronary syndrome. Participant has a significant genetic predisposition to venous thromboembolic events. Participant has a prior history of venous thromboembolic events and is not on appropriate therapeutic anticoagulation as per National Comprehensive Cancer Network or local guidelines

Primary outcomes:
measure: Main Study: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
timeFrame: From randomization to either disease progression or death, whichever occurred first (up to 1 year 7 months)
measure: Main Study + Extension Cohort: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: up to 4 years 10 months
measure: Main Study + Extension Cohort: Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review
timeFrame: Up to 4 years 10 months
Secondary outcomes:
measure: Main Study+ Extension Cohort: Objective Response Rate as Assessed by Blinded Independent Central Review
timeFrame: Up to 4 years 10 months
measure: Main Study+ Extension Cohort: Overall Survival
timeFrame: Up to 4 years 10 months
measure: Main Study+ Extension Cohort: Duration of Response as Assessed by Blinded Independent Central Review
timeFrame: Up to 4 years 10 months
measure: Main Study+ Extension Cohort: Time to Subsequent Therapy
timeFrame: Up to 4 years 10 months
measure: Main Study+ Extension Cohort: Progression-free Survival (PFS) After First Subsequent Therapy (PFS2)
timeFrame: Up to 4 years 10 months
measure: Main Study+ Extension Cohort: Time to Symptomatic Progression
timeFrame: Up to 4 years 10 months
measure: Main Study+ Extension Cohort: Intracranial Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review
timeFrame: Up to 4 years 10 months
measure: Main Study: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 4 years 10 months
measure: Main Study+ Extension Cohort: Number of Participants With Adverse Events (AEs) by Severity
timeFrame: Up to 4 years 10 months
measure: Main Study+ Extension Cohort: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: Up to 4 years 10 months
measure: Main Study+ Extension Cohort: Serum Concentration of Amivantamab
timeFrame: Up to 4 years 10 months
measure: Main Study+ Extension Cohort: Plasma Concentration of Lazertinib
timeFrame: Up to 4 years 10 months
measure: Main Study + Extension Cohort: Number of Participants With Serum Anti-amivantamab Antibodies
timeFrame: Up to 4 years 10 months
measure: Main Study+ Extension Cohort: Change From Baseline With Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NSCLC-SAQ)
timeFrame: Up to 4 years 10 months
measure: Main Study+ Extension Cohort: Change From Baseline With European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
timeFrame: Up to 4 years 10 months
measure: Main Study+ Extension Cohort: Change From Baseline With Patient-Reported Outcomes Measurement Information System -Physical Function (PROMIS-PF)
timeFrame: Up to 4 years 10 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Southern Cancer Center, PC
state: Alabama
city: Tucson
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Colorado Springs
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
state: Florida
city: Athens
country: United States
facility: University Cancer And Blood Center LLC
state: Georgia
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Grand Island
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: East Brunswick
country: United States
facility: Astera Cancer Care
state: New Jersey
city: Cincinnati
country: United States
facility: TriHealth Network
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
city: Horsham
country: United States
facility: Alliance Cancer Specialists
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology-Medical City Dallas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology Baylor Charles A Sammons Cancer Center
state: Texas
city: Grapevine
country: United States
facility: Texas Oncology
state: Texas
city: Houston
country: United States
facility: Oncology Consultants Texas
state: Texas
city: Longview
country: United States
facility: Texas Oncology - Northeast
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Wytheville
country: United States
facility: Blue Ridge Cancer Care
state: Virginia
city: Puyallup
country: United States
facility: NorthWest Medical Specialties, PLLC
state: Washington
city: Vancouver
country: United States
facility: Compass Oncology
state: Washington
city: Caba
country: Argentina
facility: CINME Centro de Investigaciones Metabolicas
city: Caba
country: Argentina
facility: IADT Instituto Argentino de Diagnostico y Tratamiento
city: Caba
country: Argentina
facility: Centro Medico Fleischer
city: Caba
country: Argentina
facility: CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
city: Cordoba
country: Argentina
facility: Hospital Privado Universitario De Cordoba
city: Córdoba
country: Argentina
facility: Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
city: Mar del Plata
country: Argentina
facility: Hospital Privado de la Comunidad
city: Viedma
country: Argentina
facility: Clínica Viedma
city: Charleroi
country: Belgium
facility: Grand Hopital De Charleroi Site Les Viviers
city: Edegem
country: Belgium
facility: UZA
city: Gent
country: Belgium
facility: UZ Gent
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis - Campus Virga Jesse
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liege
country: Belgium
facility: CHU Sart-Tilman
city: Ottignies
country: Belgium
facility: Clinique Saint Pierre
city: Belo Horizonte
country: Brazil
facility: Cetus Oncologia
city: Curitiba
country: Brazil
facility: CIONC Centro Integrado de Oncologia de Curitiba
city: Florianopolis
country: Brazil
facility: Ynova Pesquisa Clinica
city: Ipatinga
country: Brazil
facility: Fundacao Sao Francisco Xavier
city: Pelotas
country: Brazil
facility: UPCO Unidade de Pesquisa Clinica em Oncologia
city: Porto Alegre
country: Brazil
facility: Associacao Hospitalar Moinhos de Vento
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles
city: Rio de Janeiro
country: Brazil
facility: Oncoclinicas Rio de Janeiro S A
city: Rio de Janeiro
country: Brazil
facility: Instituto D Or de Pesquisa e Ensino IDOR
city: Rio de Janeiro
country: Brazil
facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
city: Salvador
country: Brazil
facility: Nucleo de Oncologia da Bahia
city: Salvador
country: Brazil
facility: Hospital Sao Rafael
city: Santo Andre
country: Brazil
facility: CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
city: Sao Paulo
country: Brazil
facility: Real e Benemerita Associacao Portuguesa de Beneficencia
city: Sao Paulo
country: Brazil
facility: Hospital Paulistano
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente A C Camargo Cancer Center
city: Sao Paulo
country: Brazil
facility: Onco Star SP Oncologia Ltda
city: Sorocaba
country: Brazil
facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
city: São Paulo
country: Brazil
facility: Hospital Nove de Julho
city: Uberlandia
country: Brazil
facility: COT - Centro Oncologico do Triangulo S.A
city: Sofia
country: Bulgaria
facility: Multifunctional Hospital for Active Treatment 'Serdika'
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment in Oncology
city: Sofia
country: Bulgaria
facility: UMHAT Sofia Med
city: Calgary
country: Canada
facility: Arthur J E Child Comprehensive Cancer Centre
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking University People s Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Beijing
country: China
facility: Beijing Chest hospital, Capital medical university
city: Changsha
country: China
facility: Hunan Cancer hospital
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: ChongQing
country: China
facility: Southwest Hospital
city: Guang Zhou
country: China
facility: The First Affiliated Hospital Sun Yat sen University
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital Sun Yat-sen University
city: Hang Zhou
country: China
facility: Zhejiang Cancer Hospital
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University College of Medicine
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
city: Harbin
country: China
facility: Harbin medical university cancer hospital
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province
city: Nanchong
country: China
facility: Affiliated Hospital of North Sichuan Medical College
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Shenzhen
country: China
facility: Shenzhen university General Hospital
city: Shenzhen
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Weifang
country: China
facility: Weifang People's Hospital
city: XI An
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
city: Yuzhong District
country: China
facility: Daping Hospital Army Characteristic Medical Center
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc - I.P.Pavlova 6
city: Ostrava- Vitkovice
country: Czechia
facility: Vitkovicka nemocnice a.s.
city: Plzen
country: Czechia
facility: Fakultni nemocnice Plzen
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Avignon Cedex 9
country: France
facility: Institut Sainte Catherine
city: Bron
country: France
facility: Hospices Civils de Lyon HCL
city: La Tronche
country: France
facility: CHU de Grenoble Hopital Albert Michallon
city: le Mans
country: France
facility: Centre Hospitalier du Mans
city: Lille
country: France
facility: CHR Hôpital Calmette
city: Marseille Cedex 20
country: France
facility: Hopital Nord
city: Montpellier Cedex 5
country: France
facility: CHU de Montpellier - Arnaud de Villeneuve
city: Paris
country: France
facility: Institut Curie
city: Pessac
country: France
facility: CHU Bordeaux
city: Rennes
country: France
facility: CHRU Hopital de Pontchaillou
city: Sain-Herblain
country: France
facility: CHU Nantes
city: Strasbourg cedex
country: France
facility: Nouvel Hopital Civil - CHU Strasbourg
city: Tours
country: France
facility: CHU Bretonneau
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin
city: Hamburg
country: Germany
facility: Asklepios Klinikum Harburg
city: Heidelberg
country: Germany
facility: Thoraxklinik am Universitatsklinikum Heidelberg
city: Heilbronn
country: Germany
facility: Onkologische Schwerpunktpraxis
city: Leipzig
country: Germany
facility: POIS Sachsen GmbH iG
city: Moers
country: Germany
facility: Bethanien Krankenhaus
city: München
country: Germany
facility: Klinikum der Universitaet Muenchen
city: Recklinghausen
country: Germany
facility: Oncologianova GmbH
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Bangalore
country: India
facility: Health Care Global Enterprises pvt Ltd
city: Gurugram
country: India
facility: Artemis Hospital
city: Kolkata
country: India
facility: Tata Medical Center
city: Mumbai
country: India
facility: Tata Memorial Hospital
city: Nasik
country: India
facility: HCG Manavta Cancer Centre
city: New Delh
country: India
facility: Rajiv Gandhi Cancer Institute and Research Centre
city: Pune
country: India
facility: Noble Hospital Pvt Ltd
city: Thane
country: India
facility: Bhaktivedanta Hospital & Research Institute
city: Beersheba
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Health Corporation
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel-Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Aviano
country: Italy
facility: CRO IRCCS Istituto Nazionale Tumori
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria Di Parma
city: Ravenna
country: Italy
facility: Ospedale S. Maria Delle Croci
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Verona
country: Italy
facility: Policlinico G.B.Rossi
city: Gunma
country: Japan
facility: National Hospital Organization Shibukawa Medical Center
city: Hyogo
country: Japan
facility: Hyogo Cancer Center
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
city: Kobe City
country: Japan
facility: Kobe City Medical Center General Hospital
city: Kurume
country: Japan
facility: Kurume University Hospital
city: Nagoya-shi
country: Japan
facility: National Hospital Organization Nagoya Medical Center
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Osaka City
country: Japan
facility: Osaka International Cancer Institute
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Toon-shi
country: Japan
facility: Ehime University Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Yamaguchi
country: Japan
facility: National Hospital Organization Iwakuni Clinical Center
city: Yamaguchi
country: Japan
facility: National Hospital Organization Yamaguchi Ube Medical Center
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Gyeongsangnam-do
country: Korea, Republic of
facility: GyeongSang National University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Mary s Hospital
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
city: Petaling Jaya
country: Malaysia
facility: Beacon Hospital Sdn Bhd
city: Subang Jaya
country: Malaysia
facility: Subang Jaya Medical Centre
city: Tanjung Bungah
country: Malaysia
facility: Mount Miriam Cancer Hospital
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
city: Leon
country: Mexico
facility: CIMOVA, Morals Vargas Centro de Investigación SC
city: Mexico
country: Mexico
facility: Health Pharma Professional Research
city: Mexico
country: Mexico
facility: Instituto Nacional de Cancerologia
city: Naucalpan
country: Mexico
facility: Oncologia Integral Satelite
city: Amsterdam
country: Netherlands
facility: VUMC Amsterdam
city: Harderwijk
country: Netherlands
facility: Ziekenhuis St Jansdal
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im Prof F Lukaszczyka
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp z o o
city: Olsztyn
country: Poland
facility: Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
city: Poznan
country: Poland
facility: Private Specialist Hospitals - MedPolonia
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
city: Lisboa
country: Portugal
facility: Uls Santa Maria - Hosp. Pulido Valente
city: Loures
country: Portugal
facility: Uls Loures Odivelas - Hosp. Loures
city: Porto
country: Portugal
facility: Uls Santo Antonio - Hosp. Santo Antonio
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials LLC
city: Nalchik
country: Russian Federation
facility: City Clinical Hospital #1
city: Saint Petersburg
country: Russian Federation
facility: Llc, Eurocityclinic
city: A Coruña
country: Spain
facility: Hosp Univ A Coruna
city: Barcelona
country: Spain
facility: Hosp. de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hosp. Univ. Quiron Dexeus
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Las Palmas de Gran Canaria
country: Spain
facility: Hosp. Univ. Insular de Gran Canaria
city: Madrid
country: Spain
facility: Hosp. Gral. Univ. Gregorio Maranon
city: Madrid
country: Spain
facility: Hosp Univ Fund Jimenez Diaz
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Madrid
country: Spain
facility: Hosp Univ Hm Sanchinarro
city: Majadahonda
country: Spain
facility: Hosp. Univ. Pta. de Hierro Majadahonda
city: Málaga
country: Spain
facility: Hosp Regional Univ de Malaga
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
city: Seville
country: Spain
facility: Hosp. Virgen Del Rocio
city: Valencia
country: Spain
facility: Hosp. Gral. Univ. Valencia
city: Valencia
country: Spain
facility: Hosp. Univ. I Politecni La Fe
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Linkoping
country: Sweden
facility: Linkoping University Hospital
city: Lund
country: Sweden
facility: Skanes universitetssjukhus
city: Umea
country: Sweden
facility: Norrlands Universitetssjukhus
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung Ho Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Adana
country: Turkey
facility: Adana City Hospital
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi
city: Ankara
country: Turkey
facility: Gazi University Hospital
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Bakirkoy Training and Research Hospital
city: Istanbul
country: Turkey
facility: Medipol Mega University Hospital
city: Istanbul
country: Turkey
facility: Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
city: Izmir
country: Turkey
facility: Medical Point
city: Cardiff
country: United Kingdom
facility: Velindre Hospital
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Centre Western General
city: London
country: United Kingdom
facility: UCL Cancer Institute
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust
city: London
country: United Kingdom
facility: The Royal Marsden NHS Trust
city: Manchester
country: United Kingdom
facility: The Christie Nhs Foundation Trust
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: