A Study to Assess the Efficacy and Safety of Zipalertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB-IIIA NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection
REZILIENT4
A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Phase 3 Study of Zipalertinib Plus Adjuvant Chemotherapy Versus Placebo Plus Adjuvant Chemotherapy in Stage IB-IIIA NSCLC Patients With Uncommon EGFR Mutations Following Complete Tumor Resection (REZILIENT4)
2 other identifiers
interventional
360
24 countries
252
Brief Summary
The purpose of this study is to compare the efficacy of zipalertinib combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in participants with early stage (stage IB-IIIA) resected non-small cell lung cancer (NSCLC) harboring uncommon epidermal growth factor receptor mutation (EGFRmt).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2025
Longer than P75 for phase_3
252 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
August 11, 2025
CompletedFirst Posted
Study publicly available on registry
August 17, 2025
CompletedStudy Start
First participant enrolled
December 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2032
May 5, 2026
April 1, 2026
3.8 years
August 11, 2025
April 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-free Survival (DFS) as Assessed by the Investigator
Up to 5 years
Secondary Outcomes (11)
Disease-free Survival Rate
At 2, 3 and 5 years
Overall Survival (OS)
Up to 5 years
Overall Survival Rate
At 2, 3 and 5 years
DFS of Central Nervous System (cDFS)
Up to 5 years
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Up to 5 years
- +6 more secondary outcomes
Study Arms (2)
Zipalertinib
EXPERIMENTALParticipants will receive adjuvant platinum-based chemotherapy consisting of cisplatin or carboplatin plus pemetrexed, administered via intravenous (IV) infusion, in combination with zipalertinib. After completion of chemotherapy, participants will continue on zipalertinib monotherapy, orally, until the participant meets any of the treatment discontinuation criteria.
Placebo
PLACEBO COMPARATORParticipants will receive adjuvant platinum-based chemotherapy consisting of cisplatin or carboplatin plus pemetrexed, administered via IV infusion, in combination with zipalertinib matching-placebo. After completion of chemotherapy, participants will continue on zipalertinib matching-placebo, until the participant meets any of the treatment discontinuation criteria.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of primary NSCLC on predominantly non-squamous histology.
- Documented EGFRmt status as determined by local testing performed at a clinical laboratory improvement amendment (CLIA) certified (United States \[US\]) or accredited (outside of the US) local laboratory, defined as either one of the following EGFRmt:
- exon20 insertion mutations (ex20ins) or
- other uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I)
- Baseline imaging assessment of the brain (MRI or CT scan) performed within 8 weeks prior to randomization must show no evidence of brain metastasis
- Complete surgical resection of the primary NSCLC is mandatory with negative surgical margins and systematic lymph node sampling or dissection.
- Complete recovery from surgery, including post-operative wound healing at the time of randomization. Randomization must occur between 4 weeks and 12 weeks following surgery.
- Eastern cooperative oncology group performance status (ECOG PS) of 0 or 1.
- Pathologic (post-operative) Stage IB, IIA, IIB, or IIIA according to the tumor nodes metastasis (TNM) staging system for lung cancer. In addition, participants with stage IIIB are eligible when regional lymph node involvement is N2.
- \- Participants with Stage IB NSCLC should be considered when disease has high-risk features (eg, visceral pleural invasion, lymphovascular invasion or high-grade histology) and participants are suitable for adjuvant chemotherapy according to international guidelines such as the 2025 European Society for Medical Oncology guideline.
- Archival tumor tissue available for submission, with minimum quantity sufficient to evaluate EGFRmt status and, where possible, other biomarkers.
You may not qualify if:
- Is currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Treatment with any of the following within the time frame specified:
- Zipalertinib (TAS6417/CLN-081) or any other EGFR inhibitor at any time.
- Pre-operative or post-operative or planned radiation therapy for the current lung cancer.
- Any prior systemic anticancer therapy (e.g., neoadjuvant chemotherapy), including investigational therapy, for treatment of NSCLC.
- Major surgery (including primary tumor surgery, excluding placement of vascular access) within 4 weeks of the first dose of study treatment.
- Treatment with an investigational drug within five half-lives of the compound or any of its related material, if known.
- Has received only wedge resections (complete anatomic segmentectomy is acceptable).
- Past medical history of interstitial lung disease (ILD)/pneumonitis, drug-induced ILD/pneumonitis or any evidence of clinically active ILD/pneumonitis.
- Unable to swallow tablets or has any disease or condition that may significantly affect gastrointestinal (GI) absorption of zipalertinib (such as inflammatory bowel disease, malabsorption syndrome, or prior significant bowel resection).
- Has a history of any other cancer except for any of the following:
- Non-melanoma skin cancer treated with curative intent
- Carcinoma in situ treated with curative intent
- Other curatively treated cancer, with no evidence of disease for \>3 years following the end of treatment and, in the opinion of the treating physician, has no substantial risk of recurrence.
- Known history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) that is unstable or not controlled with treatment. Screening not required.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (252)
Alaska Oncology and Hematology
Anchorage, Alaska, 99508, United States
City of Hope Comprehensive Cancer Center - Duarte
Duarte, California, 91010, United States
City of Hope Comprehensive Cancer Center Orange County Lennar Foundation Cancer Center
Irvine, California, 92618, United States
Scripps Clinic Torrey Pines
La Jolla, California, 92037, United States
Kaiser Permanente - Vallejo Medical Center
Vallejo, California, 94589, United States
Georgetown University School of Medicine
Washington D.C., District of Columbia, 20007, United States
D&H Cancer Research Center - Margate
Margate, Florida, 33063, United States
Alpha Oncology Research
Orange City, Florida, 32763, United States
City of Hope - Atlanta
Newnan, Georgia, 30265, United States
University of Illinois Medical Center
Chicago, Illinois, 60612, United States
Profound Research LLC at Michigan Hematology and Oncology Consultants
Dearborn, Michigan, 48126, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Memorial Sloan Kettering Cancer Center - Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Cancer Center - Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Cancer Center - Bergen
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center - Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Cancer Center - Westchester
Harrison, New York, 10604, United States
Long Island Jewish Medical Center
Lake Success, New York, 11042, United States
Perlmutter Cancer Center - 34th Street
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center - New York
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center - Nassau
Uniondale, New York, 11553, United States
Atrium Health Wake Forest Baptist - Comprehensive Cancer Center
Charlotte, North Carolina, 28204, United States
Durham Veterans Affairs Health Care System
Durham, North Carolina, 27705, United States
Gabrail Cancer and Research Center
Canton, Ohio, 44718, United States
Gibbs Cancer Center and Research Institute Spartanburg
Spartanburg, South Carolina, 29303, United States
Virginia Cancer Specialists - Arlington Office
Arlington, Virginia, 22201, United States
Virginia Cancer Specialists - Fairfax Office
Fairfax, Virginia, 22031, United States
Virginia Cancer Specialists - Bristow Office
Manassas, Virginia, 20110, United States
Virginia Cancer Specialists - Reston
Reston, Virginia, 20190, United States
Virginia Cancer Specialists - Woodbridge Office
Woodbridge, Virginia, 22191, United States
Instituto Argentino de Diagnóstico y Tratamiento
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1122, Argentina
Centro de Investigación Pergamino SA
Pergamino, Buenos Aires, B2700KMP, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, B1629AHJ, Argentina
CEMAIC - Centro de Especialidades Médicas Ambulatorias e Investigación Clínica
Córdoba, X5008HHW, Argentina
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, 2200, Australia
GenesisCare - North Shore
St Leonards, New South Wales, 2065, Australia
Saint John of God - Subiaco Hospital
Subiaco, Western Australia, 6008, Australia
Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen, 2650, Belgium
Algemeen Ziekenhuis Sint-Maarten
Mechelen, Antwerpen, 2800, Belgium
Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg
Leuven, Flemish Brabant, 3000, Belgium
NOHC - Núcleo de Oncologia e Hematologia do Ceará - José Lourenço
Fortaleza, Ceará, 60115-281, Brazil
Centro Regional Integrado de Oncologia
Fortaleza, Ceará, 60335-480, Brazil
Centro de Pesquisas Clínicas Em Oncologia - CPCO
Cachoeiro de Itapemirim, Espírito Santo, 29308-065, Brazil
Hospital Santa Rita
Vitória, Espírito Santo, 29043-260, Brazil
Núcleo de Oncologia da Bahia Ondina - NOB
Salvador, Estado de Bahia, 40170-110, Brazil
Oncoclinicas Oncovida - Brasilia
Brasília, Federal District, 70390-150, Brazil
Cetus Oncologia - Unidade Belo Horizonte
Belo Horizonte, Minas Gerais, 30110-022, Brazil
Cenantron Centro Avançado de Tratamento Oncológico
Belo Horizonte, Minas Gerais, 30130-090, Brazil
Centro Integrado de Oncologia de Curitiba (CIONC)
Curitiba, Paraná, 80810-050, Brazil
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, 50070-902, Brazil
Centro de Pesquisa Vencer e Oncoclínica - Teresina
Teresina, Piauí, 64.049-200, Brazil
Instituto D'Or de Pesquisa e Ensino - Rio de Janeiro
Botafogo, Rio de Janeiro, 22281-100, Brazil
Liga Contra o Câncer - Centro Avançado de Oncologia
Natal, Rio Grande do Norte, 59062-000, Brazil
Clínica Viver
Centro Santa Maria, Rio Grande do Sul, 97015-450, Brazil
Hospital Bruno Born
Lajeado, Rio Grande do Sul, 95900-022, Brazil
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-090, Brazil
Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre
Porto Alegre, Rio Grande do Sul, 90440-010, Brazil
Hospital Mãe de Deus - Centro Integrado de Oncologia
Porto Alegre, Rio Grande do Sul, 91210-250, Brazil
Grupo ELORA
Florianópolis, Santa Catarina, 88020-210, Brazil
CHO Centro - Centro de Hematologia e Oncologia de Joinville
Joinville, Santa Catarina, 89201-260, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos - Hospital de Amor
Barretos, São Paulo, 14784-400, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, 17210-180, Brazil
Instituto de Oncologia de Sorocaba
Sorocaba, São Paulo, 18030-005, Brazil
A Beneficência Portuguesa de São Paulo
São Paulo, 01323-001, Brazil
Instituto de Assistência Médica ao Servidor Público Estadual
São Paulo, 04039-004, Brazil
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2, Canada
William Osler Health System - Brampton Civic Hospital
Brampton, Ontario, L6R317, Canada
London Health Sciences Centre
London, Ontario, N6A 4G5, Canada
Sunnybrook Health Sciences Centre - Bayview Campus
Toronto, Ontario, M4N3M5, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G2M9, Canada
Hôpital Saint-André
Bordeaux, Aquitane, 33000, France
Hôpital Louis Pradel
Bron, Auvergne-Rhône-Alpes, 69500, France
Hôpital de la Croix Rousse
Lyon, Auvergne-Rhône-Alpes, 69004, France
Centre Léon Bérard
Lyon, Auvergne-Rhône-Alpes, 69008, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France
L'Hôpital Nord-Ouest (HNO) - Villefranche-sur-Saône
Villefranche-de-Rouergue, Aveyron, 12200, France
Hôpital Côte De Nacre
Caen, Basse-Normandie, 14033, France
Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard, 30029, France
Hôpital Emile Muller
Mulhouse, Grand Est, 8051, France
Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, 35033, France
Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec
Saint-Herblain, Loire-Atlantique, 44800, France
Centre Hospitalier Universitaire d'Angers
Angers, Maine-et-Loire, 49 933, France
CHU d Angers
Angers, Maine-et-Loire, 49 933, France
Institut de Cancérologie de l'Ouest - Angers
Angers, Maine-et-Loire, 49055, France
CHU de Nimes - Caremeau Nord
Nîmes, Occitanie, 30029, France
Centre Hospitalier Le Mans
Le Mans, Pays de la Loire Region, 72037, France
Hopital Prive du Confluet
Nantes, Pays de la Loire Region, 44277, France
Hôpital Privé du Confluent
Nantes, Pays de la Loire Region, 44277, France
Hopital Nord Ouest
Gleizé, Rhône, 69 655, France
Gustave Roussy
Villejuif, Val-De-Marne, 94800, France
Hôpital Universitaire Pitié Salpêtrière
Paris, 75013, France
Hôpital Ambroise-Paré
Boulogne-Billancourt, Île-de-France Region, 92100, France
Centre Hospitalier Intercommunal de Créteil
Créteil, Île-de-France Region, 94000, France
Groupe Hospitalier Paris Saint-Joseph
Paris, Île-de-France Region, 75014, France
Hôpital Bichat - Claude-Bernard
Paris, Île-de-France Region, 75018, France
SLK-Kliniken - Fachklinik Löwenstein
Löwenstein, Baden-Wurttemberg, 74245, Germany
Krankenhaus Nordwest
Frankfurt am Main, Hesse, 60488, Germany
Universitätsklinikum Gießen und Marburg - Gießen
Giessen, Hesse, 35392, Germany
Kliniken der Stadt Köln
Cologne, North Rhine-Westphalia, 51067, Germany
Saint Savvas Anticancer - Oncological Hospital of Athens
Athens, Attica, 115 22, Greece
General Hospital for Thoracic Diseases Sotiria
Athens, Attica, 11527, Greece
Metaxa Cancer Hospital of Piraeus
Athens, Attica, 18537, Greece
BioClinic Thessaloniki
Athens, Central Macedonia, 54622, Greece
Interbalkan Medical Center of Thessaloniki
Thessaloniki, Central Macedonia, 57001, Greece
Hong Kong Sanatorium and Hospital
Happy Valley, Hong Kong
Humanity & Health Clinical Trial Centre
Hong Kong, Hong Kong
Queen Mary Hospital - Hong Kong
Hong Kong, Hong Kong
Princess Margaret Hospital
Kowloon, Hong Kong
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
Meldola, Forlì-Cesena, 47014, Italy
Azienda Socio Sanitaria Territoriale (ASST) di Bergamo Ovest
Legnano, Milan, 20025, Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan, Milan, 20133, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Milan, 20141, Italy
Istituto Europeo di Oncologia
Milan, Milan, 20141, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Milan, 20162, Italy
Ospedale del Mare
Naples, Naples, 80147, Italy
Ospedale Santa Maria delle Croci di Ravenna
Lugo, Ravenna, 48022, Italy
Azienda Ospedaliera Complesso Ospedaliero San Giovanni - Addolorata
Roma, Rome, 00184, Italy
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino, 10060, Italy
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano, Torino, 10043, Italy
Ospedale P. Pederzoli - Casa di Cura Privata S.p.A.
Peschiera del Garda, Verona, 37019, Italy
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo - Alessandria
Alessandria, 15121, Italy
Azienda Ospedaliero Universitaria Delle Marche
Ancona, 60126, Italy
Humanitas Gavazzeni
Bergamo, 24125, Italy
Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII
Bergamo, 24127, Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi
Bologna, 40138, Italy
Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco - Catania/ Presidio G. Rodolico
Catania, 95125, Italy
Azienda Unita Sanitaria Locale toscana Nord Ovest
Livorno, 57124, Italy
Azienda Unità Sanitaria Locale Toscana Nord Ovest
Livorno, 57124, Italy
Azienda Ospedaliera Complesso Ospedaliero San Giovanni - Addolorata
Milan, 20132, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
Milan, 20132, Italy
Azienda Ospedaliero - Universitaria di Modena
Modena, 41124, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Azienda Ospedaliera Universitaria Senese - L'ospedale Santa Maria alle Scotte
Siena, 53100, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126, Italy
Nagoya Univeristy Hospital
Nagoya, Aichi-ken, 466-8560, Japan
Aichi Cancer Center
Nagoya, Aiti [Aichi], 464-8681, Japan
Kurume University Hospital
Kurume-Shi, Fukuoka, 830-0011, Japan
Hiroshima University Hospital
Hiroshima, Hirosima [Hiroshima], 734-8551, Japan
Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Hukuoka [Fukuoka], 811-1395, Japan
Hyogo Cancer Center
Akashi, Hyōgo, 673-8558, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501, Japan
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191, Japan
Kindai University Hospital
Osakasayama-Shi, Osaka, 589-8511, Japan
Saitama Medical University - International Medical Center
Hidaka-Shi, Saltama, 350-1298, Japan
Shizuoka Cancer Center
Sunto-gun, Sizuoka [Shizuoka], 411-8777, Japan
National Cancer Center Hospital East
Kashiwa-shi, Tiba [Chiba], 277-8577, Japan
Cancer Institute Hospital of JFCR
Koto, Tokyo, 135-8550, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023, Japan
Yamagata University Hospital
Yamagata, Yamagata, 990-9585, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Osaka City General Hospital
Osaka, 534-0021, Japan
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
Osaka, 541-8567, Japan
National Cancer Center Hospital
Tokyo, 104-0045, Japan
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, 15586, Malaysia
Hospital Pulau Pinang
Pulau Pinang, Pulau Pinang, 10450, Malaysia
Hospital Picaso
Petaling Jaya, Selangor, 46300, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
Sunway Medical Centre
Selangor Darul Ehsan, 47500, Malaysia
Preparaciones Oncológicas S.C.
León, Guanajuato, 37178, Mexico
Centro Oncológico Alianza XXI
Mexico City, Mexico City, 06760, Mexico
Clínica Integral Internacional de Oncología S de RL de CV
Mirador, Puebla, 72530, Mexico
Ziekenhuis St Jansdal Harderwijk
Harderwijk, Gelderland, 3844, Netherlands
Radboud Universitair Medisch Centrum
Nijmegen, Gelderland, 6525 GA, Netherlands
Leids Universitair Medisch Centrum (LUMC)
Leiden, South Holland, 2333 ZA, Netherlands
Hospital Nacional Arzobispo Loayza
Lima Cercado, Lima region, 15082, Peru
Clínicas Oncosalud Sede Guardia Civil
San Borja, Lima region, 15036, Peru
Luis Alberto Vera Valdivia
San Borja, Lima region, 15036, Peru
IPOR - Instituto Peruano de Oncología & Radioterapia - Sede Principal
San Isidro, Lima region, 15036, Peru
Detecta Clínica
Surquillo, Lima region, 15038, Peru
Mruk-Med I Sp. z o.o.
Rzeszów, Podkarpackie Voivodeship, 35-021, Poland
Warmińsko-mazurskie Centrum Chorób Płuc w Olsztynie
Olsztyn, Warmian-Masurian Voivodeship, 10-357, Poland
Institutul Oncologic Bucuresti - Prof. Dr. Alexandru Trestioreanu
Bucharest, Bucharest, 022328, Romania
Monza Oncology Day Hospital
Bucharest, Bucharest, 13823, Romania
Centrul de Radioterapie Amethyst Cluj
Floreşti, Cluj, 407280, Romania
Ovidius Clinical Hospital
Ovidiu, Constanța County, 905900, Romania
Clinica MC Gral Ploiesti
Ploieşti, Prahova, 100010, Romania
Oncocenter - Oncologie Clinica
Timișoara, Timiș County, 300166, Romania
Spitalul Județean de Urgență Satu Mare
Satu Mare, 440192, Romania
Curie Oncology - Farrer - 10-05
Singapore, Central Singapore, 217562, Singapore
P.H Feng Research Centre
Singapore, Central Singapore, 308433, Singapore
Tan Tock Seng Hospital
Singapore, North East, 308433, Singapore
National Cancer Centre Singapore
Singapore, 168583, Singapore
Kyungpook National University Chilgok Hospital
Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi], 41404, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Catholic University of Korea St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
Chungbuk National University Hospital
Cheongju-si, Gyeonggido [Kyonggi-do], 28644, South Korea
National Cancer Center - Korea
Goyang-si, Gyeonggido [Kyonggi-do], 10408, South Korea
Keimyung University Dongsan Hospital
Daegu, Gyeongsangbugdo [Kyongsangbuk-do], 42601, South Korea
Kosin University Gospel Hospital
Pusan, Gyeongsangnam-do, 49267, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612, South Korea
Gyeongsang National University Hospital
Jinju, Gyeongsangnamdo [Kyongsangnam-do], 52727, South Korea
Inha University Hospital
Incheon, Incheon Gwang'yeogsi [Inch'on-Kwangyokshi], 22332, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, 58128, South Korea
Jeonbuk National University Hospital
Jeonju, Jeonrabugdo [Chollabuk-do], 561-712, South Korea
Korea University Anam Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 02841, South Korea
Severance Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 03722, South Korea
Konkuk University Medical Center
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 05030, South Korea
The Catholic University of Korea - Seoul St. Mary's Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 06591, South Korea
Korea University Guro Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 08308, South Korea
Hanyang University Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 4763, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 07061, South Korea
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120, Spain
Institut Català d'Oncologia Badalona
Badalona, Barcelona, 08916, Spain
Hospital de Sabadell
Sabadell, Barcelona, 08208, Spain
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, 43204, Spain
Instituto Oncológico Dr Rosell
Barcelona, 08028, Spain
Hospital Universitari Vall d'Hebrón
Barcelona, 08035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Universitario Clínico San Cecilio PTS
Granada, 18016, Spain
Hospital Universitario Lucus Augusti
Lugo, 27003, Spain
MD Anderson Cancer Center Madrid
Madrid, 28033, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Quirónsalud Málaga
Málaga, 29004, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Hospital Universitari i Politècnic La Fe
Valencia, 46026, Spain
Chulabhorn Hospital
Bang Kapi, Bangkok, 10240, Thailand
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700, Thailand
King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, 10330, Thailand
Lampang Cancer Hospital
Muang, Changwat Lampang, 10400, Thailand
Songklanagarind Hospital
Hat Yai, Changwat Songkhla, 90110, Thailand
Navamindradhiraj University - Faculty of Medicine Vajira Hospital
Bangkok, Khet Dusit, 10300, Thailand
Başkent Üniversitesi Adana Dr Turgut Noyan Uygulama ve Araştirma Merkezi
Yüreğir, Adana, 01250, Turkey (Türkiye)
Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve Arastirma Hastanesi
Etlik, Ankara, 06010, Turkey (Türkiye)
Dicle Üniversitesi Tıp Fakültesi
Sur, Diyarbakır, 21280, Turkey (Türkiye)
Gaziantep Universitesi - Şahinbey Araştırma ve Uygulama Hastanesi
Şehitkamil, Gaziantep, 27310, Turkey (Türkiye)
Memorial Bahçelievler Hospital
Bahçelievler, Istanbul, 34180, Turkey (Türkiye)
İstinye Üniversite Hastanesi Liv Hospital Bahcesehir
Esenyurt, Istanbul, 34517, Turkey (Türkiye)
İ.A.Ü. VM Medical Park Florya Hastanesi
Küçükçekmece, Istanbul, 34295, Turkey (Türkiye)
Medicana International Izmir Hastanesi
Turgutlu, Manisa, 45400, Turkey (Türkiye)
VM Medical Park Samsun Hastanesi
Atakum, Samsun, 55200, Turkey (Türkiye)
Medical Park Seyhan Hastanesi
Adana, 01040, Turkey (Türkiye)
T.C. Saglik Bakanligi Adana Sehir Egitim ve Arastirma Hastanesi
Adana, 01370, Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, 6520, Turkey (Türkiye)
Liv Hospital Ankara
Ankara, 6680, Turkey (Türkiye)
Trakya Üniversitesi Sağlık Araştırma ve Uygulama Merkezi
Edirne, 22130, Turkey (Türkiye)
Ozel Gaziantep Medical Point Hastanesi
Gaziantep, 27584, Turkey (Türkiye)
T.C. Saglik Bakanligi - Istanbul Il Saglik Mudurlugu - Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722, Turkey (Türkiye)
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, 35575, Turkey (Türkiye)
The Christie NHS Foundation Trust
Manchester, England, M20 4BX, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, England, NG5 1PB, United Kingdom
Torbay and South Devon NHS Foundation Trust
Torquay, England, TQ27AA, United Kingdom
Velindre University NHS Trust
Cardiff, Wales, CF14 2TL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2025
First Posted
August 17, 2025
Study Start
December 22, 2025
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
October 1, 2032
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share