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
MARIPOSA-2
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
4 other identifiers
interventional
776
29 countries
249
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2021
Longer than P75 for phase_3
249 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2021
CompletedFirst Posted
Study publicly available on registry
August 3, 2021
CompletedStudy Start
First participant enrolled
November 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2023
CompletedResults Posted
Study results publicly available
April 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2027
ExpectedApril 22, 2026
April 1, 2026
1.6 years
July 30, 2021
October 16, 2024
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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)
PFS is defined as the time from randomization until the date of objective disease progression or death, whichever came first, as assessed by BICR according to RECIST version 1.1. Progressed disease: Sum of diameters increased by greater than or equal to (\>=)20 percent (%) and \>=5 millimeter (mm) from nadir (including baseline if it was smallest sum).
From randomization to either disease progression or death, whichever occurred first (up to 1 year 7 months)
Main Study + Extension Cohort: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Follow-up for the extension cohort is still ongoing and thus results from the analysis that includes the extension cohort will be reported up on study completion.
up to 4 years 10 months
Main Study + Extension Cohort: Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review
Up to 4 years 10 months
Secondary Outcomes (16)
Main Study+ Extension Cohort: Objective Response Rate as Assessed by Blinded Independent Central Review
Up to 4 years 10 months
Main Study+ Extension Cohort: Overall Survival
Up to 4 years 10 months
Main Study+ Extension Cohort: Duration of Response as Assessed by Blinded Independent Central Review
Up to 4 years 10 months
Main Study+ Extension Cohort: Time to Subsequent Therapy
Up to 4 years 10 months
Main Study+ Extension Cohort: Progression-free Survival (PFS) After First Subsequent Therapy (PFS2)
Up to 4 years 10 months
- +11 more secondary outcomes
Study Arms (5)
Arm A: LACP/ACP-L
EXPERIMENTALLACP dosing (study start until 6 November 2022): Participants will receive Lazertinib orally along with Amivantamab, Pemetrexed, and Carboplatin as IV infusion starting on Cycle 1 Day 1 for 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab, Pemetrexed and Lazertinib as maintenance until disease progression. ACP-L dosing (from 7 November 2022 until study completion): Participants will receive Amivantamab, Pemetrexed, and Carboplatin starting on Cycle 1 Day 1 for 4 cycles. Lazertinib in ACP-L will start on Cycle 5 Day 1 or sooner if carboplatin is discontinued before cycle 4 (each cycle consists of 21 days). Beginning with Cycle 5 Day 1, participants will receive Amivantamab, Pemetrexed and Lazertinib as maintenance until disease progression.
Arm B: CP (Carboplatin and Pemetrexed)
ACTIVE COMPARATORParticipants will receive Pemetrexed in combination with Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Pemetrexed as maintenance until disease progression.
Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed)
EXPERIMENTALParticipants will receive Amivantamab, Pemetrexed, and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab and Pemetrexed as maintenance until disease progression.
Arm A2 (Extension Cohort): ACP-L
EXPERIMENTALParticipants will receive Amivantamab, Pemetrexed and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days), Lazertinib will start on C5D1 or sooner if carboplatin is discontinued earlier). After 4 cycles, participants will receive Pemetrexed, Amivantamab, Lazertinib as maintenance until disease progression.
Arm C2 (Extension Cohort): ACP
EXPERIMENTALParticipants will receive Amivantamab, Pemetrexed, and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab and Pemetrexed as maintenance until disease progression.
Interventions
Lazertinib will be administered orally.
Amivantamab will be administered as an IV infusion.
Pemetrexed will be administered as an IV infusion.
Carboplatin will be administered as an IV infusion.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (249)
Southern Cancer Center, PC
Mobile, Alabama, 36608, United States
Arizona Oncology Associates
Tucson, Arizona, 85711, United States
City of Hope
Duarte, California, 91010, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
University of California Irvine
Orange, California, 92868, United States
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, 80907, United States
Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
Fort Lauderdale, Florida, 33308, United States
University Cancer And Blood Center LLC
Athens, Georgia, 30607, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Nebraska Cancer Specialists
Grand Island, Nebraska, 68803, United States
Astera Cancer Care
East Brunswick, New Jersey, 08816, United States
TriHealth Network
Cincinnati, Ohio, 45220, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Kaiser Permanente Northwest
Portland, Oregon, 97227, United States
Alliance Cancer Specialists
Horsham, Pennsylvania, 19044, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Baptist Cancer Center
Memphis, Tennessee, 38120, United States
Texas Oncology-Medical City Dallas
Dallas, Texas, 75230, United States
Texas Oncology Baylor Charles A Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology
Grapevine, Texas, 76051, United States
Oncology Consultants Texas
Houston, Texas, 77030, United States
Texas Oncology - Northeast
Longview, Texas, 75601, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Blue Ridge Cancer Care
Wytheville, Virginia, 24382, United States
NorthWest Medical Specialties, PLLC
Puyallup, Washington, 98373, United States
Compass Oncology
Vancouver, Washington, 98684, United States
CINME Centro de Investigaciones Metabolicas
Caba, C1027AAP, Argentina
IADT Instituto Argentino de Diagnostico y Tratamiento
CABA, C1122, Argentina
Centro Medico Fleischer
CABA, C1414, Argentina
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
CABA, C1431FWO, Argentina
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba, 5000, Argentina
Hospital Privado Universitario De Cordoba
Córdoba, X5016KEH, Argentina
Hospital Privado de la Comunidad
Mar del Plata, B7602CBM, Argentina
Clínica Viedma
Viedma, R8500ACE, Argentina
Grand Hopital De Charleroi Site Les Viviers
Charleroi, 6060, Belgium
UZA
Edegem, 2650, Belgium
UZ Gent
Ghent, 9000, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, 3500, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHU Sart-Tilman
Liège, 4000, Belgium
Clinique Saint Pierre
Ottignies, 1340, Belgium
Cetus Oncologia
Belo Horizonte, 30110-017, Brazil
CIONC Centro Integrado de Oncologia de Curitiba
Curitiba, 80810 050, Brazil
Ynova Pesquisa Clinica
Florianópolis, 88020-210, Brazil
Fundacao Sao Francisco Xavier
Ipatinga, 35162 189, Brazil
UPCO Unidade de Pesquisa Clinica em Oncologia
Pelotas, 96020 080, Brazil
Associacao Hospitalar Moinhos de Vento
Porto Alegre, 90035-001, Brazil
Hospital Ernesto Dornelles
Porto Alegre, 90160-093, Brazil
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro, 22250-905, Brazil
Instituto D Or de Pesquisa e Ensino IDOR
Rio de Janeiro, 22281 100, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro, 22775 001, Brazil
Nucleo de Oncologia da Bahia
Salvador, 40170 110, Brazil
Hospital Sao Rafael
Salvador, 41253 190, Brazil
CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia
Santo André, 09060 650, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, 01323 900, Brazil
Hospital Paulistano
São Paulo, 01323-000, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, 01327 001, Brazil
Hospital Nove de Julho
São Paulo, 01409902, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, 01509 900, Brazil
Onco Star SP Oncologia Ltda
São Paulo, 04543-000, Brazil
IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
Sorocaba, 18030-005, Brazil
COT - Centro Oncologico do Triangulo S.A
Uberlândia, 38408-150, Brazil
Multifunctional Hospital for Active Treatment 'Serdika'
Sofia, 1303, Bulgaria
Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'
Sofia, 1407, Bulgaria
Specialized Hospital for Active Treatment in Oncology
Sofia, 1756, Bulgaria
UMHAT Sofia Med
Sofia, 1797, Bulgaria
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021, China
Peking University People's Hospital
Beijing, 100044, China
Beijing Cancer Hospital Chest Tumor Internal Medicine dept. II
Beijing, 100142, China
Beijing Cancer Hospital
Beijing, 100142, China
Chinese PLA General Hospital
Beijing, 100853, China
Beijing Chest hospital, Capital medical university
Beijing, 101199, China
Hunan Cancer Hospital Chest Tumor Internal Medicine dept. II
Changsha, 410013, China
Hunan Cancer hospital
Changsha, 410013, China
Sichuan Cancer Hospital
Chengdu, 610041, China
West China Hospital Sichuan University
Chengdu, 610041, China
Chongqing University Cancer Hospital
Chongqing, 400000, China
Southwest Hospital
Chongqing, 400038, China
Daping Hospital Army Characteristic Medical Center
Chongqing, 400042, China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, 510080, China
Sun Yat-Sen Memorial Hospital Sun Yat-sen University
Guangzhou, 510120, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, 310009, China
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, 310009, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310016, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Harbin medical university cancer hospital
Harbin, 150000, China
Huizhou Municipal Central Hospital
Huizhou, 516001, China
Taizhou Hospital of Zhejiang Province
Linhai, 317000, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, 637503, China
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, 200025, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Shanghai East Hospital
Shanghai, 310000, China
Shenzhen university General Hospital
Shenzhen, 518055, China
Cancer Hospital Chinese Academy of Medical Sciences
Shenzhen, 518116, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
Weifang People's Hospital
Weifang, 261000, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061, China
Yantai Yuhuangding Hospital
Yantai, 264000, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Fakultni nemocnice Olomouc - I.P.Pavlova 6
Olomouc, 775 20, Czechia
Vitkovicka nemocnice a.s.
Ostrava- Vitkovice, 70300, Czechia
Fakultni nemocnice Plzen
Pilsen, 30599, Czechia
Rigshospitalet
Copenhagen, DK 2100, Denmark
Institut Sainte Catherine
Avignon, 84918, France
Hospices Civils de Lyon HCL
Bron, 69500, France
CHU de Grenoble Hopital Albert Michallon
La Tronche, 38700, France
Centre Hospitalier du Mans
Le Mans, 72000, France
CHR Hôpital Calmette
Lille, 59000, France
Hopital Nord
Marseille, 13915, France
CHU de Montpellier - Arnaud de Villeneuve
Montpellier, 34295, France
Institut Curie
Paris, 75005, France
CHU Bordeaux
Pessac, 33604, France
CHRU Hopital de Pontchaillou
Rennes, 35033, France
CHU Nantes
Sain-Herblain, 44800, France
Nouvel Hopital Civil - CHU Strasbourg
Strasbourg, 67091, France
CHU Bretonneau
Tours, 37000, France
Evangelische Lungenklinik Berlin
Berlin, 13125, Germany
Asklepios Klinikum Harburg
Hamburg, 21075, Germany
Thoraxklinik am Universitatsklinikum Heidelberg
Heidelberg, 69126, Germany
Onkologische Schwerpunktpraxis
Heilbronn, 74072, Germany
POIS Sachsen GmbH iG
Leipzig, 04357, Germany
Bethanien Krankenhaus
Moers, 47441, Germany
Klinikum der Universitaet Muenchen
München, 80336, Germany
Oncologianova GmbH
Recklinghausen, 45659, Germany
Universitaetsklinikum Regensburg
Regensburg, 93053, Germany
Queen Mary Hospital
Hong Kong, 999077, Hong Kong
Health Care Global Enterprises pvt Ltd
Bangalore, 560027, India
Artemis Hospital
Gurugram, 122001, India
Tata Medical Center
Kolkata, 700160, India
Tata Memorial Hospital
Mumbai, 400012, India
HCG Manavta Cancer Centre
Nashik, 422002, India
Rajiv Gandhi Cancer Institute and Research Centre
New Delh, 110085, India
Noble Hospital Pvt Ltd
Pune, 411013, India
Bhaktivedanta Hospital & Research Institute
Thane, 411107, India
Soroka University Medical Center
Beersheba, 84101, Israel
Rambam Health Corporation
Haifa, 3109601, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Chaim Sheba Medical Center
Ramat Gan, 5262100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
CRO IRCCS Istituto Nazionale Tumori
Aviano, 33081, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
Azienda Ospedaliero-Universitaria Di Parma
Parma, 43126, Italy
Ospedale S. Maria Delle Croci
Ravenna, 48121, Italy
Istituto Nazionale Tumori Regina Elena
Roma, 00144, Italy
Policlinico G.B.Rossi
Verona, 37134, Italy
National Hospital Organization Shibukawa Medical Center
Gunma, 377-0280, Japan
Hyogo Cancer Center
Hyōgo, 673-8558, Japan
Kanagawa Cancer Center
Kanagawa, 241-8515, Japan
Kobe City Medical Center General Hospital
Kobe, 650 0047, Japan
Kurume University Hospital
Kurume, 830-0011, Japan
National Hospital Organization Nagoya Medical Center
Nagoya, 460-0001, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Osaka International Cancer Institute
Osaka, 541 8567, Japan
Shizuoka Cancer Center
Shizuoka, 411 8777, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Tokyo, 113 8677, Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135 8550, Japan
Ehime University Hospital
Toon-shi, 791-0295, Japan
Wakayama Medical University Hospital
Wakayama, 641 8510, Japan
National Hospital Organization Iwakuni Clinical Center
Yamaguchi, 740-8510, Japan
National Hospital Organization Yamaguchi Ube Medical Center
Yamaguchi, 755-0241, Japan
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, 25100, Malaysia
Beacon Hospital Sdn Bhd
Petaling Jaya, 46050, Malaysia
Subang Jaya Medical Centre
Subang Jaya, 47500, Malaysia
Mount Miriam Cancer Hospital
Tanjung Bungah, 11200, Malaysia
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, 44280, Mexico
CIMOVA, Morals Vargas Centro de Investigación SC
León, 37000, Mexico
Health Pharma Professional Research
México, 03100, Mexico
Instituto Nacional de Cancerologia
México, 14080, Mexico
Oncologia Integral Satelite
Naucalpan, 53100, Mexico
VUMC Amsterdam
Amsterdam, 1081 HV, Netherlands
Ziekenhuis St Jansdal
Harderwijk, 3844 DG, Netherlands
Erasmus MC
Rotterdam, 3015 GD, Netherlands
Centrum Onkologii im Prof F Lukaszczyka
Bydgoszcz, 85 796, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80 952, Poland
Szpitale Pomorskie Sp z o o
Gdynia, 81 519, Poland
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, 10-357, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
Poznan, 60 569, Poland
Private Specialist Hospitals - MedPolonia
Poznan, 60-693, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02-781, Poland
Uls Santa Maria - Hosp. Pulido Valente
Lisbon, 1769-001, Portugal
Uls Loures Odivelas - Hosp. Loures
Loures, 2674 514, Portugal
Uls Santo Antonio - Hosp. Santo Antonio
Porto, 4099-001, Portugal
Instituto Portugues de Oncologia
Porto, 4200072, Portugal
Pan American Center for Oncology Trials LLC
Rio Piedras, 00917, Puerto Rico
City Clinical Hospital #1
Nal'chik, 360000, Russia
Llc, Eurocityclinic
Saint Petersburg, 197022, Russia
National Cancer Center
Gyeonggi-do, 10408, South Korea
CHA Bundang Medical Center, CHA University
Gyeonggi-do, 13496, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, 13620, South Korea
GyeongSang National University Hospital
Gyeongsangnam-do, 52727, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, 06591, South Korea
Hosp Univ A Coruna
A Coruña, 15006, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hosp. Univ. Quiron Dexeus
Barcelona, 08028, Spain
Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
Hosp Clinic de Barcelona
Barcelona, 08036, Spain
Hosp. Univ. Insular de Gran Canaria
Las Palmas de Gran Canaria, 35016, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007, Spain
Hosp Univ Fund Jimenez Diaz
Madrid, 28040, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Univ. La Paz
Madrid, 28046, Spain
Hosp Univ Hm Sanchinarro
Madrid, 28050, Spain
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, 28222, Spain
Hosp Regional Univ de Malaga
Málaga, 29010, Spain
Clinica Univ. de Navarra
Pamplona, 31008, Spain
Hosp. Virgen Del Rocio
Seville, 41013, Spain
Hosp. Gral. Univ. Valencia
Valencia, 46014, Spain
Hosp. Univ. I Politecni La Fe
Valencia, 46026, Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45, Sweden
Linkoping University Hospital
Linköping, 581 85, Sweden
Skanes universitetssjukhus
Lund, 221 85, Sweden
Norrlands Universitetssjukhus
Umeå, 901 85, Sweden
Akademiska Sjukhuset
Uppsala, 75181, Sweden
Changhua Christian Hospital
Changhua, 500, Taiwan
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561, Taiwan
Chung Shan Medical University Hospital
Taichung, 402, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Adana City Hospital
Adana, 01060, Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, 06520, Turkey (Türkiye)
Gazi University Hospital
Ankara, 06560, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, 06800, Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, 22030, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34098, Turkey (Türkiye)
Bakirkoy Training and Research Hospital
Istanbul, 34147, Turkey (Türkiye)
Medipol Mega University Hospital
Istanbul, 34214, Turkey (Türkiye)
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722, Turkey (Türkiye)
Medical Point
Izmir, 35575, Turkey (Türkiye)
Velindre Hospital
Cardiff, CF14 2TL, United Kingdom
Edinburgh Cancer Centre Western General
Edinburgh, EH4 2XU, United Kingdom
UCL Cancer Institute
London, NW1 2PG, United Kingdom
Guys and St Thomas NHS Foundation Trust
London, SE1 9RT, United Kingdom
The Royal Marsden NHS Trust
London, SW3 6JJ, United Kingdom
The Christie Nhs Foundation Trust
Manchester, M20 4BX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Executive Medical Director
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
July 30, 2021
First Posted
August 3, 2021
Study Start
November 17, 2021
Primary Completion
July 10, 2023
Study Completion (Estimated)
November 30, 2027
Last Updated
April 22, 2026
Results First Posted
April 16, 2025
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu