A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)

Phase 3

Recruiting

• Conditions: Gastroesophageal Cancer
• Interventions: Drug: Trifluridine-Tipiracil; Biological: Sacituzumab tirumotecan; Drug: Irinotecan; Drug: Rescue medication; Drug: Supportive care measures; Drug: Paclitaxel; Drug: Docetaxel

• Registration Number: NCT06356311
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study will compare how safe and effective sacituzumab tirumotecan is versus the treatment of physician's choice (TPC) in participants with advanced/metastatic gastroesophageal adenocarcinoma. The primary hypothesis of this study is sacituzumab tirumotecan is superior to TPC with respect to Overall Survival (OS).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-04
• Study First Posted: 2024-04-10
• Study Start: 2024-05-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-25
• Primary Completion: 2027-01-04
• Study Completion: 2028-05-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Has a histologically-or cytologically-confirmed diagnosis of advanced, unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma
• Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology. Lesions situated in a previously-irradiated area are considered measurable if progression has been shown in such lesions.
• Has received, and progressed on, at least 2 prior chemotherapy and/or immunotherapy regimens for advanced, unresectable or metastatic gastroesophageal adenocarcinoma.
• Participants are eligible regardless of human epidermal growth factor receptor-2 (HER2) status. Participants who are HER2+ must have previously received trastuzumab where available/appropriate
• Has adequate organ function
• Has provided tumor tissue sample for determination of trophoblast cell-surface antigen 2 (TROP2) status by the central laboratory before randomization for stratification
• Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except for alopecia and vitiligo). Participants with endocrine related AEs who are adequately treated with hormone replacement therapy are eligible
• Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by the local site investigator/radiology
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days before randomization
• Has ability to swallow oral medication for those who may receive trifluridine-tipiracil
• Human immunodeficiency virus (HIV) infected participants must have well-controlled HIV on antiretroviral therapy (ART)
• Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
• Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria

• Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
• Has Grade ≥2 peripheral neuropathy
• Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of corrected QT interval (QTcF) to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention
• Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before the first dose of study intervention
• Has received prior treatment with a trophoblast antigen 2(TROP2) targeted antibody-drug conjugate (ADC), a topoisomerase 1 inhibitor based, and/or a topoisomerase 1 inhibitor-based chemotherapy.
• Has received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention
• Has received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and/or has had radiation pneumonitis
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
• Is currently receiving a strong and/or moderate inducer/inhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting study intervention is 2 weeks
• Has received an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has an active infection requiring systemic therapy
• HIV infected participants with a history of Kaposi's sarcoma and/or Multicentric Castlemans's Disease
• Has concurrent active hepatitis B (defined as hepatitis B surface antigen (HBsAg) positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
• Has had major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention. Anticipation of the need for major surgery during the course of treatment with study intervention is also exclusionary
• Has severe hypersensitivity (Grades >=3) to sacituzumab tirumotecan (MK-2870), any of its excipients, and/or to another biologic therapy
• Has a history of (noninfectious) pneumonitis/ interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sacituzumab tirumotecan	Supportive care measures	Participants will receive sacituzumab tirumotecan at a dose of 4mg/kg by intravenous (IV) infusion on days 1, 15, and 29 of every 42-day cycle.
Treatment of Physician's Choice (TPC)	Trifluridine-Tipiracil	TPC include either trifluridine-tipiracil (35 mg/m\^2 orally (PO) twice a day (BID) on days 1 to 5 and 8 to 12 of every 28-day cycle), irinotecan (150 mg/m\^2 IV on days 1 and 15 of every 28-day cycle), paclitaxel (80 mg/m\^2 IV on days 1, 8, and 15 of every 28-day cycle), or docetaxel (75 mg/m\^2 IV on day 1 of every 21-day cycle).
Sacituzumab tirumotecan	Sacituzumab tirumotecan	Participants will receive sacituzumab tirumotecan at a dose of 4mg/kg by intravenous (IV) infusion on days 1, 15, and 29 of every 42-day cycle.
Treatment of Physician's Choice (TPC)	Docetaxel	TPC include either trifluridine-tipiracil (35 mg/m\^2 orally (PO) twice a day (BID) on days 1 to 5 and 8 to 12 of every 28-day cycle), irinotecan (150 mg/m\^2 IV on days 1 and 15 of every 28-day cycle), paclitaxel (80 mg/m\^2 IV on days 1, 8, and 15 of every 28-day cycle), or docetaxel (75 mg/m\^2 IV on day 1 of every 21-day cycle).
Treatment of Physician's Choice (TPC)	Supportive care measures	TPC include either trifluridine-tipiracil (35 mg/m\^2 orally (PO) twice a day (BID) on days 1 to 5 and 8 to 12 of every 28-day cycle), irinotecan (150 mg/m\^2 IV on days 1 and 15 of every 28-day cycle), paclitaxel (80 mg/m\^2 IV on days 1, 8, and 15 of every 28-day cycle), or docetaxel (75 mg/m\^2 IV on day 1 of every 21-day cycle).
Treatment of Physician's Choice (TPC)	Irinotecan	TPC include either trifluridine-tipiracil (35 mg/m\^2 orally (PO) twice a day (BID) on days 1 to 5 and 8 to 12 of every 28-day cycle), irinotecan (150 mg/m\^2 IV on days 1 and 15 of every 28-day cycle), paclitaxel (80 mg/m\^2 IV on days 1, 8, and 15 of every 28-day cycle), or docetaxel (75 mg/m\^2 IV on day 1 of every 21-day cycle).
Sacituzumab tirumotecan	Rescue medication	Participants will receive sacituzumab tirumotecan at a dose of 4mg/kg by intravenous (IV) infusion on days 1, 15, and 29 of every 42-day cycle.
Treatment of Physician's Choice (TPC)	Paclitaxel	TPC include either trifluridine-tipiracil (35 mg/m\^2 orally (PO) twice a day (BID) on days 1 to 5 and 8 to 12 of every 28-day cycle), irinotecan (150 mg/m\^2 IV on days 1 and 15 of every 28-day cycle), paclitaxel (80 mg/m\^2 IV on days 1, 8, and 15 of every 28-day cycle), or docetaxel (75 mg/m\^2 IV on day 1 of every 21-day cycle).

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to ~ 31 months	OS is defined as the time from randomization to death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DOR)	Up to ~ 48 months	For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Objective Response Rate (ORR)	Up to ~ 25 months	ORR is defined as the percentage of participants with CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
Number of Participants Who Discontinue Study Intervention Due to an AE	Up to ~ 48 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Progression-free survival (PFS)	Up to ~ 25 months	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Number of Participants Who Experience an Adverse Event (AE)	Up to ~ 48 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Trial Locations

Locations (162)

Hôpital Saint-Louis ( Site 1201); 🇫🇷 Paris, France

NCT-Department of Medical Oncology ( Site 1302); 🇩🇪 Heidelberg, Baden-Wurttemberg, Germany

Universitätsmedizin Göttingen - Georg-August-Universität ( Site 1310); 🇩🇪 Goettingen, Niedersachsen, Germany

Banner MD Anderson Cancer Center ( Site 0119); 🇺🇸 Gilbert, Arizona, United States

UCLA Hematology/Oncology - Santa Monica ( Site 0140); 🇺🇸 Los Angeles, California, United States

AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0129); 🇺🇸 Orlando, Florida, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0108); 🇺🇸 Marietta, Georgia, United States

University of Chicago Medical Center ( Site 0120); 🇺🇸 Chicago, Illinois, United States

University of Kentucky Chandler Medical Center-Medical Oncology ( Site 0124); 🇺🇸 Lexington, Kentucky, United States

The University of Louisville, James Graham Brown Cancer Center-James Graham Brown Cancer Center ( Si; 🇺🇸 Louisville, Kentucky, United States

Norton Audubon Hospital-Norton Cancer Institute - Audubon ( Site 0105); 🇺🇸 Louisville, Kentucky, United States

Henry Ford Hospital ( Site 0107); 🇺🇸 Detroit, Michigan, United States

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0138); 🇺🇸 Fargo, North Dakota, United States

UPMC Hillman Cancer Center ( Site 0126); 🇺🇸 Pittsburgh, Pennsylvania, United States

MUSC Hollings Cancer Center-Hematology Oncology ( Site 0122); 🇺🇸 Charleston, South Carolina, United States

Sanford Cancer Center ( Site 0136); 🇺🇸 Sioux Falls, South Dakota, United States

The West Clinic, PLLC dba West Cancer Center ( Site 0110); 🇺🇸 Germantown, Tennessee, United States

Inova Schar Cancer ( Site 0106); 🇺🇸 Fairfax, Virginia, United States

Institut Jules Bordet-GastroIntestinal Medical Oncology ( Site 1003); 🇧🇪 Anderlecht, Bruxelles-Capitale, Region De, Belgium

Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1001); 🇧🇪 Bruxelles, Bruxelles-Capitale, Region De, Belgium

UZ Leuven-Digestive Oncology ( Site 1000); 🇧🇪 Leuven, Vlaams-Brabant, Belgium

AZ Delta vzw ( Site 1002); 🇧🇪 Roeselare, West-Vlaanderen, Belgium

Centro de Pesquisa Clínica do Instituto do Câncer do Ceará ( Site 0405); 🇧🇷 Fortaleza, Ceara, Brazil

Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0406); 🇧🇷 Natal, Rio Grande Do Norte, Brazil

Hospital de Caridade de Ijuí ( Site 0412); 🇧🇷 Ijui, Rio Grande Do Sul, Brazil

Centro de Hematologia e Oncologia ( Site 0404); 🇧🇷 Joinville, Santa Catarina, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0401); 🇧🇷 Barretos., Sao Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0411); 🇧🇷 São José do Rio Preto, Sao Paulo, Brazil

A. C. Camargo Cancer Center ( Site 0409); 🇧🇷 Sao Paulo, Brazil

IBCC - Núcleo de Pesquisa e Ensino ( Site 0402); 🇧🇷 Sao Paulo, Brazil

McGill University Health Centre ( Site 0201); 🇨🇦 Montréal, Quebec, Canada

James Lind Centro de Investigacion del Cancer ( Site 0506); 🇨🇱 Temuco, Araucania, Chile

Bradfordhill-Clinical Area ( Site 0501); 🇨🇱 Santiago., Region M. De Santiago, Chile

Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0503); 🇨🇱 Santiago, Region M. De Santiago, Chile

FALP-UIDO ( Site 0500); 🇨🇱 Santiago, Region M. De Santiago, Chile

Clínica UC San Carlos de Apoquindo-Hemato-Oncology ( Site 0502); 🇨🇱 Santiago, Region M. De Santiago, Chile

Anhui Provincial Cancer Hospital-medical oncology ( Site 3016); 🇨🇳 Hefei, Anhui, China

Second Affiliated hospital of Anhui Medical University-Oncology ( Site 3038); 🇨🇳 Hefei, Anhui, China

Chongqing University Three Gorges Hospital ( Site 3036); 🇨🇳 Chongqing, Chongqing, China

Fujian Cancer Hospital ( Site 3007); 🇨🇳 Fuzhou, Fujian, China

The 900th Hospital of the Joint Logistics Support Force of PLA ( Site 3008); 🇨🇳 Fuzhou, Fujian, China

The First Affiliated hospital of Xiamen University-oncology ( Site 3011); 🇨🇳 Xiamen, Fujian, China

Zhongshan Hospital Affiliated to Xiamen University ( Site 3013); 🇨🇳 Xiamen, Fujian, China

Southern Medical University Nanfang Hospital-Department of Oncology ( Site 3019); 🇨🇳 Guangzhou, Guangdong, China

Sun Yatsen University Cancer Center ( Site 3001); 🇨🇳 Guangzhou, Guangdong, China

Cancer Hospital of Shantou University Medical College ( Site 3034); 🇨🇳 Shantou, Guangdong, China

Affiliated Cancer Hospital of Guangxi Medical University ( Site 3047); 🇨🇳 Nanning, Guangxi, China

Fourth Hospital of Hebei Medical University ( Site 3015); 🇨🇳 Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital-Harbin Medical University Cancer Hospital ( Site 3005); 🇨🇳 Harbin, Heilongjiang, China

Henan Cancer Hospital-henan cancer hospital ( Site 3002); 🇨🇳 Zhengzhou, Henan, China

Hubei Cancer Hospital ( Site 3012); 🇨🇳 Wuhan, Hubei, China

Xiangyang Central Hospital ( Site 3045); 🇨🇳 Xiangyang, Hubei, China

Hunan Cancer Hospital ( Site 3014); 🇨🇳 Changsha, Hunan, China

The First Affiliated Hospital of Soochow University ( Site 3040); 🇨🇳 Suzhou, Jiangsu, China

The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 3037); 🇨🇳 Nanchang, Jiangxi, China

Jilin Province Tumor Hospital ( Site 3018); 🇨🇳 Changchun, Jilin, China

LinYi Cancer Hospital-Gastrology department ( Site 3024); 🇨🇳 Linyi, Shandong, China

Renji Hosp,Shanghai Jiao Tong University School of Medicine ( Site 3042); 🇨🇳 Shangai, Shanghai, China

Fudan University Shanghai Cancer Center-medical oncology ( Site 3009); 🇨🇳 Shanghai, Shanghai, China

Zhongshan Hospital,Fudan University-Oncology ( Site 3003); 🇨🇳 Shanghai, Shanghai, China

West China Hospital, Sichuan University ( Site 3035); 🇨🇳 Cheng Du, Sichuan, China

Sichuan Cancer hospital. ( Site 3030); 🇨🇳 Chengdu, Sichuan, China

Nanchong Central Hospital (Jiangdong Campus) ( Site 3029); 🇨🇳 Nanchong, Sichuan, China

Xinjiang Medical University Cancer Hospital - Urumchi-The No.11 of Surgery building ( Site 3010); 🇨🇳 Xinjiang, Xinjiang, China

Yunnan Province Cancer Hospital ( Site 3031); 🇨🇳 Kunming, Yunnan, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Oncology ( Site 3006); 🇨🇳 Hangzhou, Zhejiang, China

FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Sit; 🇨🇴 Bogota, Distrito Capital De Bogota, Colombia

Fundación Valle del Lili-Fundacion Valle del Lili ( Site 0607); 🇨🇴 Cali, Valle Del Cauca, Colombia

Taizhou Hospital of Zhejiang Province ( Site 3020); 🇨🇳 Linhai, Zhejiang, China

Yueqing People's Hospital ( Site 3041); 🇨🇳 Yueqing, Zhejiang, China

Centro Cancerológico del Caribe (CECAC) ( Site 0606); 🇨🇴 Barranquilla, Atlantico, Colombia

Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0600); 🇨🇴 Valledupar, Cesar, Colombia

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0603); 🇨🇴 Bogota, Distrito Capital De Bogota, Colombia

Rigshospitalet ( Site 1102); 🇩🇰 Copenhagen, Hovedstaden, Denmark

Aalborg Universitetshospital, Syd-Department of Oncology ( Site 1103); 🇩🇰 Aalborg, Nordjylland, Denmark

Odense Universitetshospital-Department of oncology ( Site 1101); 🇩🇰 Odense, Syddanmark, Denmark

Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1211); 🇫🇷 Bordeaux, Aquitaine, France

Centre François Baclesse ( Site 1202); 🇫🇷 Caen, Calvados, France

CHU Rangueil-Digestive oncology department ( Site 1210); 🇫🇷 Toulouse, Haute-Garonne, France

Institut Mutualiste Montsouris-Oncology ( Site 1216); 🇫🇷 Paris, Ile-de-France, France

Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1203); 🇫🇷 Rennes, Ille-et-Vilaine, France

Centre Oscar Lambret ( Site 1206); 🇫🇷 Lille, Nord-Pas-de-Calais, France

CENTRE LEON BERARD-Medical oncology ( Site 1208); 🇫🇷 Lyon, Rhone-Alpes, France

Centre Hospitalier Universitaire de Poitiers ( Site 1209); 🇫🇷 Poitiers, Vienne, France

Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 1307); 🇩🇪 Dresden, Sachsen, Germany

Städtisches Krankenhaus Kiel-2. Medizinische Klinik ( Site 1306); 🇩🇪 Kiel, Schleswig-Holstein, Germany

Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 1304); 🇩🇪 Berlin, Germany

Facharztzentrum Eppendorf-Facharztzentrum Eppendorf ( Site 1300); 🇩🇪 Hamburg, Germany

Queen Mary Hospital ( Site 3100); 🇭🇰 Hong Kong, Hong Kong

Prince of Wales Hospital ( Site 3102); 🇭🇰 Shatin, Hong Kong

Queen Elizabeth Hospital ( Site 3101); 🇭🇰 Yau Ma Tei, Hong Kong

Hillel Yaffe Medical Center ( Site 1604); 🇮🇱 Hadera, Israel

Rambam Health Care Campus-Oncology Division ( Site 1600); 🇮🇱 Haifa, Israel

Hadassah Medical Center ( Site 1603); 🇮🇱 Jerusalem, Israel

Rabin Medical Center ( Site 1605); 🇮🇱 Petah Tikva, Israel

Sourasky Medical Center ( Site 1602); 🇮🇱 Tel Aviv, Israel

Azienda Ospedaliera Universitaria dell'Università "Luigi Van-UOC Oncoematologia ( Site 1704); 🇮🇹 Napoli, Campania, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1703); 🇮🇹 Roma, Lazio, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1700); 🇮🇹 Milan, Lombardia, Italy

Azienda Ospedaliero Universitaria Pisana ( Site 1702); 🇮🇹 Pisa, Toscana, Italy

Ospedale San Raffaele-Oncologia Medica ( Site 1701); 🇮🇹 Milano, Italy

Aichi Cancer Center Hospital ( Site 3307); 🇯🇵 Nagoya, Aichi, Japan

National Cancer Center Hospital East ( Site 3300); 🇯🇵 Kashiwa, Chiba, Japan

Kochi Medical School Hospital ( Site 3304); 🇯🇵 Nankoku, Kochi, Japan

National Cancer Center Hospital ( Site 3301); 🇯🇵 Chuo, Tokyo, Japan

Cancer Institute Hospital of JFCR ( Site 3306); 🇯🇵 Koto, Tokyo, Japan

National Hospital Organization Kyushu Cancer Center ( Site 3303); 🇯🇵 Fukuoka, Japan

Osaka International Cancer Institute ( Site 3305); 🇯🇵 Osaka, Japan

Saitama Prefectural Cancer Center ( Site 3302); 🇯🇵 Saitama, Japan

Seoul National University Bundang Hospital ( Site 3504); 🇰🇷 Seongnam, Kyonggi-do, Korea, Republic of

Seoul National University Hospital-Oncology ( Site 3503); 🇰🇷 Seoul, Korea, Republic of

Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3500); 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center-Department of Oncology ( Site 3501); 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center-Division of Hematology/Oncology ( Site 3502); 🇰🇷 Seoul, Korea, Republic of

The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3505); 🇰🇷 Seoul, Korea, Republic of

Hospital Pulau Pinang ( Site 3403); 🇲🇾 George Town, Pulau Pinang, Malaysia

Sarawak General Hospital-Radiotherapy Unit ( Site 3401); 🇲🇾 Kuching, Sarawak, Malaysia

National Cancer Institute-Radiotherapy and Oncology ( Site 3404); 🇲🇾 Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia

University Malaya Medical Centre-Clinical Oncology ( Site 3402); 🇲🇾 Kuala Lumpur, Malaysia

Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 3408); 🇲🇾 Kuala Lumpur, Malaysia

COI Centro Oncologico Internacional S.A.P.I. de C.V.-Investigation Unit COI ( Site 0802); 🇲🇽 Mexico City, Distrito Federal, Mexico

CANCER TREAMTENT CLINIC AND CLINICAL TRIALS SA DE CV ( Site 0814); 🇲🇽 Guadalajara, Jalisco, Mexico

Centro de Investigacion Clinica de Oaxaca ( Site 0810); 🇲🇽 Oaxaca de Juarez, Oaxaca, Mexico

Centro Potosino de Investigación Médica ( Site 0801); 🇲🇽 San Luis Potosí, San Luis Potosi, Mexico

Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 0904); 🇵🇪 Concepcion, Junin, Peru

Hospital de Alta Complejidad La Libertad-Unidad de Investigación en Oncología ( Site 0902); 🇵🇪 Trujillo, La Libertad, Peru

Clínicas AUNA Sede Chiclayo ( Site 0907); 🇵🇪 Chiclayo, Lambayeque, Peru

Clínica Internacional - Sede San Borja ( Site 0906); 🇵🇪 Lima, Peru

IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 0905); 🇵🇪 Lima, Peru

INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 0900); 🇵🇪 Lima, Peru

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1807); 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site; 🇵🇱 Warszawa, Mazowieckie, Poland

Bialostockie Centrum Onkologii ( Site 1804); 🇵🇱 Bialystok, Podlaskie, Poland

Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej " Profil Jednego Dnia " ( Site 1810); 🇵🇱 Gdynia, Pomorskie, Poland

Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 1811); 🇵🇱 Kielce, Swietokrzyskie, Poland

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1801); 🇵🇱 Koszalin, Zachodniopomorskie, Poland

Hospital Universitario Central de Asturias-Medical Oncology ( Site 1902); 🇪🇸 Oviedo, Asturias, Spain

Hospital Universitario Marqués de Valdecilla ( Site 1901); 🇪🇸 Santander, Cantabria, Spain

CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 1905); 🇪🇸 A Coruna, La Coruna, Spain

COMPLEJO HOSPITALARIO DE NAVARRA-Medical Oncology ( Site 1904); 🇪🇸 Pamplona, Navarra, Spain

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1900); 🇪🇸 Barcelona, Spain

Hospital Clinico San Carlos ( Site 1903); 🇪🇸 Madrid, Spain

China Medical University Hospital ( Site 3603); 🇨🇳 Taichung, Taiwan

National Cheng Kung University Hospital-Clinical Trial Center ( Site 3604); 🇨🇳 Tainan, Taiwan

National Taiwan University Hospital ( Site 3600); 🇨🇳 Taipei, Taiwan

Taipei Veterans General Hospital ( Site 3601); 🇨🇳 Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch ( Site 3602); 🇨🇳 Taoyuan, Taiwan

Chulalongkorn University ( Site 3702); 🇹🇭 Bangkok, Krung Thep Maha Nakhon, Thailand

Faculty of Medicine Siriraj Hospital ( Site 3700); 🇹🇭 Bangkok, Krung Thep Maha Nakhon, Thailand

Songklanagarind hospital ( Site 3701); 🇹🇭 HatYai, Songkhla, Thailand

Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2104); 🇹🇷 Adana, Turkey

Hacettepe Universite Hastaneleri-oncology hospital ( Site 2100); 🇹🇷 Ankara, Turkey

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2101); 🇹🇷 Ankara, Turkey

Dicle Üniversitesi-oncology ( Site 2108); 🇹🇷 Diyarbakir, Turkey

Atatürk Üniversitesi-onkoloji ( Site 2111); 🇹🇷 Erzurum, Turkey

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2106); 🇹🇷 Istanbul, Turkey

Samsun Medical Park Hastanesi-medical oncology ( Site 2110); 🇹🇷 Samsun, Turkey

Yuzuncu Yil University Dursun Odaba Tp Merkezi-Medical Oncology ( Site 2109); 🇹🇷 Van, Turkey

Addenbrooke's Hospital ( Site 2203); 🇬🇧 Cambridge, Cambridgeshire, United Kingdom

Ninewells Hospital and Medical School-Oncology Petty ( Site 2209); 🇬🇧 Dundee, Dundee City, United Kingdom

St Bartholomew's Hospital ( Site 2206); 🇬🇧 London, London, City Of, United Kingdom

The Christie NHS Foundation Trust-Medical Oncology ( Site 2201); 🇬🇧 Manchester, United Kingdom