Clinical trial NCT04538664: A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
Official title: A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: EGFR Exon20ins Mutation
NSCLC
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-09-04
Enrollment: 308
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 compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations.


Eligibility criteria: Inclusion Criteria:

* Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation
* Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream
* A female participant of childbearing potential must have a negative serum or urine 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

Exclusion Criteria:

* Participant has evidence of synchronous NSCLC disease (as suggested by genetic characterization or radiographic appearance)
* Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible)
* Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation
* Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis
* Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid

Primary outcomes:
measure: 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 occurs first (up to 29 months)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 5 years 3 months
measure: Duration of Response (DoR)
timeFrame: Up to 5 years 3 months
measure: Overall Survival (OS)
timeFrame: Up to 5 years 3 months
measure: Time to Subsequent Therapy (TST)
timeFrame: Up to 5 years 3 months
measure: Progression-Free Survival After First Subsequent Therapy (PFS2)
timeFrame: Up to 5 years 3 months
measure: Time to Symptomatic Progression (TTSP)
timeFrame: Up to 5 years 3 months
measure: Number of Participants Treatment-emergent Adverse Events (TEAEs)
timeFrame: From Day 1 to 5 years 2 months
measure: Number of Participants TEAEs With Severity
timeFrame: From Day 1 to 5 years 2 months
measure: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: Up to 5 years 3 months
measure: Number of Participants With Vital Signs Abnormalities
timeFrame: Up to 5 years 3 months
measure: Number of Participants With Physical Examination Abnormalities
timeFrame: Up to 5 years 3 months
measure: Serum Concentration of Amivantamab
timeFrame: Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1)
measure: Number of Participants With Anti-Amivantamab Antibodies
timeFrame: Day 1 (Cycles 1, 2, 3, 5, 7, 9, 11, 13), Day 2 (Cycle 1)
measure: Change From Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
timeFrame: From baseline to 5 years 3 months
measure: Change From Baseline in Patient Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF)
timeFrame: From baseline to 5 years 3 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Santa Monica
country: United States
facility: UCLA
state: California
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer & Research Institute
state: Florida
city: Athens
country: United States
facility: University Cancer And Blood Center LLC
state: Georgia
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: East Brunswick
country: United States
facility: Regional Cancer Care Associates LLC
state: New Jersey
city: New York
country: United States
facility: Langone Health at NYC University, NYU School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
city: Tyler
country: United States
facility: Texas Oncology Pa
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Salem
country: United States
facility: Blue Ridge Cancer Care
state: Virginia
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
city: Kogarah
country: Australia
facility: St George Hospital
city: Malvern
country: Australia
facility: Cabrini Medical Centre
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
city: Leuven
country: Belgium
facility: UZ Leuven
city: Roeselare
country: Belgium
facility: Algemeen Ziekenhuis Delta
city: Yvoir
country: Belgium
facility: CHU UCL Namur - Site Godinne
city: Barretos
country: Brazil
facility: Fundacao Pio XII
city: Belo Horizonte
country: Brazil
facility: Cetus Oncologia
city: Florianopolis
country: Brazil
facility: Ynova Pesquisa Clinica
city: Ijui
country: Brazil
facility: Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra O Cancer
city: Pelotas
country: Brazil
facility: UPCO Unidade de Pesquisa Clinica em Oncologia
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
city: Rio De Janeiro
country: Brazil
facility: Ministerio da Saude Instituto Nacional do Cancer
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: Sao Paulo
country: Brazil
facility: Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente A C Camargo Cancer Center
city: Sao Paulo
country: Brazil
facility: Núcleo de Pesquisa São Camilo
city: Sorocaba
country: Brazil
facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
city: Vitoria
country: Brazil
facility: Hospital Evangélico de Cachoeiro de Itapemirim
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
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: Beijing
country: China
facility: Peking University International Hospital
city: Changchun
country: China
facility: Jilin cancer hospital
city: Changsha
country: China
facility: Hunan Cancer hospital
city: Changzhou
country: China
facility: The First People's Hospital Of Changzhou
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Guang Zhou
country: China
facility: The First Affiliated Hospital Sun Yat sen University
city: Hang Zhou
country: China
facility: Zhejiang Cancer Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University College of Medicine
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: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
city: Shenzhen
country: China
facility: Cancer hospital Chinese Academy of Medical Sciences, Shenzhen Center
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Weifang
country: China
facility: Weifang People's Hospital
city: Wuhan
country: China
facility: TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
city: Wuxi
country: China
facility: Hospital of Jiangnan University
city: XI An
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Bordeaux
country: France
facility: Institut Bergonie
city: Bron
country: France
facility: Hospices Civils de Lyon HCL
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
city: le mans Cedex 9
country: France
facility: Centre Hospitalier Le Mans
city: Lille CEDEX
country: France
facility: CHR Hôpital Calmette
city: NANTES cedex 1
country: France
facility: CHU Nantes - Hopital Nord Laënnec
city: Paris
country: France
facility: Institut Curie
city: Pessac
country: France
facility: CHU Bordeaux
city: Saint Mande
country: France
facility: HIA Begin
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Berlin
country: Germany
facility: Evangelische Lungenklinik Berlin
city: Gauting
country: Germany
facility: Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting
city: Heidelberg
country: Germany
facility: Thoraxklinik am Universitatsklinikum Heidelberg
city: Heilbronn
country: Germany
facility: Onkologische Schwerpunktpraxis
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln
city: Koeln
country: Germany
facility: Kliniken der Stadt Koeln gGmbH
city: Moers
country: Germany
facility: Bethanien Krankenhaus
city: Oldenburg
country: Germany
facility: Pius-Hospital Oldenburg
city: Recklinghausen
country: Germany
facility: Oncologianova GmbH
city: Budapest
country: Hungary
facility: Orszagos Koranyi Tbc es Pulmonologiai Intezet
city: Gyöngyös
country: Hungary
facility: Mátrai Gyógyintézet-Bronchológia
city: Szekesfehervar
country: Hungary
facility: Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz
city: Torokbalint
country: Hungary
facility: Tudogyogyintezet Torokbalint
city: Hyderabad
country: India
facility: Basavatarakam Indo-American 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 Delhi
country: India
facility: Rajiv Gandhi Cancer Institute & Research Centre
city: Pune
country: India
facility: Noble Hospital Pvt Ltd
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Tel-Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Bologna
country: Italy
facility: A O U Sant Orsola Malpighi
city: Catania
country: Italy
facility: Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Monza
country: Italy
facility: San Gerardo Hospital
city: Ravenna
country: Italy
facility: Ospedale S. Maria Delle Croci
city: Roma
country: Italy
facility: Irccs Gemelli
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Bunkyo Ku
country: Japan
facility: Juntendo University Hospital
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
city: Himeji
country: Japan
facility: National Hospital Organization Himeji Medical Center
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
city: Kishiwada
country: Japan
facility: Kishiwada City Hospital
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
city: Kurume
country: Japan
facility: Kurume University Hospital
city: Matsusaka
country: Japan
facility: Matsusaka Municipal Hospital
city: Nagoya Shi
country: Japan
facility: Aichi Cancer Center Hospital
city: Nagoya-shi
country: Japan
facility: National Hospital Organization Nagoya Medical Center
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Osaka Sayama shi
country: Japan
facility: Kindai University Hospital
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
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 Yamaguchi Ube Medical Center
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Gyeongsangnam-do
country: Korea, Republic of
facility: GyeongSang National University Hospital
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung 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: George Town
country: Malaysia
facility: Hospital Pulau Pinang
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Chihuahua
country: Mexico
facility: Centro Oncologico de Chihuahua
city: Ciudad de Mexico
country: Mexico
facility: Mexico Centre for Clinical Research, S.A. de C.V.
city: Ciudad de Mexico
country: Mexico
facility: Médica Sur
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Cancerologia
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
city: Mexico
country: Mexico
facility: Health Pharma Professional Research
city: Monterrey
country: Mexico
facility: i Can Oncology Center
city: Naucalpan
country: Mexico
facility: Oncologia Integral Satelite
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: Private Specialist Hospitals - MedPolonia
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
city: Lisboa
country: Portugal
facility: Hosp. Cuf Descobertas
city: Lisboa
country: Portugal
facility: Uls Sao Jose - Hosp. Sto Antonio Dos Capuchos
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario do Porto, EPE
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia Espinho E P E
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials LLC
city: Irkutsk
country: Russian Federation
facility: Irkutsk Regional Oncology Dispensary
city: Krasnogorsk
country: Russian Federation
facility: Moscow City Oncology Hospital № 62
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Oncology Dispensary
city: Kuzmolovsky
country: Russian Federation
facility: Leningrad Regional Oncology Dispensary
city: Moscow
country: Russian Federation
facility: MCK
city: Nalchik
country: Russian Federation
facility: City Clinical Hospital #1
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhny Novgorod Regional Oncological Dispensary
city: Saint Petersburg
country: Russian Federation
facility: N.N. Petrov Research Institute Of Oncology
city: Saint-Petersburg
country: Russian Federation
facility: Leningrad Regional Clinical Hospital
city: St-Petersburg
country: Russian Federation
facility: Oncology Medical Clinics AV Medical group
city: Tomsk
country: Russian Federation
facility: Tomsk Cancer Research Institute
city: Ufa
country: Russian Federation
facility: Bashkir State Medical University
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Clinical Oncology Hospital
city: A Coruna
country: Spain
facility: Hosp Univ A Coruna
city: Badalona
country: Spain
facility: Inst. Cat. D'Oncologia-Badalona
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: Burgos
country: Spain
facility: Hosp. Univ. de Burgos
city: Madrid
country: Spain
facility: Hosp. Gral. Univ. Gregorio Maranon
city: Madrid
country: Spain
facility: Hosp. Univ. Ramon Y Cajal
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Majadahonda
country: Spain
facility: Hosp. Univ. Pta. de Hierro Majadahonda
city: Málaga
country: Spain
facility: Hosp Virgen de La Victoria
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
city: Seville
country: Spain
facility: Hosp. Virgen Del Rocio
city: Zaragoza
country: Spain
facility: Hosp. Clinico Univ. Lozano Blesa
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation
city: New Taipei
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital and Medical College
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Songkla
country: Thailand
facility: Songklanagarind Hospital, Prince of Songkla University
city: Adana
country: Turkey
facility: Adana City Hospital
city: Adana
country: Turkey
facility: Başkent University Medical Faculty Adana Application and Research Center
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 Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
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: Izmir Medical Park Hospital
city: Dnipro
country: Ukraine
facility: Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
city: Kyiv
country: Ukraine
facility: Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
city: Kyiv
country: Ukraine
facility: National Cancer Institute
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Centre Western General
city: London
country: United Kingdom
facility: The Royal Marsden NHS Trust
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Trust
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: