A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)

Phase 3

Active, not recruiting

• Conditions: Metastatic Non-small Cell Lung Cancer
• Interventions: Biological: Pembrolizumab (+) Berahyaluronidase alfa; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Biological: Pembrolizumab; Drug: Filgrastim; Drug: Pegylated filgrastim

• Registration Number: NCT05722015
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab (+) berahyaluronidase alfa vs intravenous (IV) pembrolizumab, administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab (+) berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-01-27
• Study First Posted: 2023-02-10
• Study Start: 2023-02-14
• Primary Completion: 2024-07-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Study Completion: 2028-05-22

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 377

Inclusion Criteria

• Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC).
• Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated.
• Has a life expectancy of at least 3 months.

Exclusion Criteria

• Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
• Has received prior systemic anticancer therapy for metastatic NSCLC.
• Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
• Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids.
• Has received radiation therapy to the lung (>30 Gray) within 6 months of start of study intervention.
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Has an active autoimmune disease that has required systemic treatment in past 2 years.
• Has an active infection requiring systemic therapy.
• Has a history of human immunodeficiency virus (HIV) infection.
• Has a history of Hepatitis B or C.
• Has not adequately recovered from major surgery or has ongoing surgical complications.
• Has a history of allogenic tissue/solid organ transplant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 (Pembrolizumab (+) Berahyaluronidase alfa+ Platinum Doublet Chemotherapy)	Pembrolizumab (+) Berahyaluronidase alfa	Participants with treatment-naïve metastatic NSCLC will receive pembrolizumab (+) berahyaluronidase alfa SC in combination with platinum doublet chemotherapy.
Arm 1 (Pembrolizumab (+) Berahyaluronidase alfa+ Platinum Doublet Chemotherapy)	Pemetrexed	Participants with treatment-naïve metastatic NSCLC will receive pembrolizumab (+) berahyaluronidase alfa SC in combination with platinum doublet chemotherapy.
Arm 1 (Pembrolizumab (+) Berahyaluronidase alfa+ Platinum Doublet Chemotherapy)	Cisplatin	Participants with treatment-naïve metastatic NSCLC will receive pembrolizumab (+) berahyaluronidase alfa SC in combination with platinum doublet chemotherapy.
Arm 1 (Pembrolizumab (+) Berahyaluronidase alfa+ Platinum Doublet Chemotherapy)	Carboplatin	Participants with treatment-naïve metastatic NSCLC will receive pembrolizumab (+) berahyaluronidase alfa SC in combination with platinum doublet chemotherapy.
Arm 1 (Pembrolizumab (+) Berahyaluronidase alfa+ Platinum Doublet Chemotherapy)	Paclitaxel	Participants with treatment-naïve metastatic NSCLC will receive pembrolizumab (+) berahyaluronidase alfa SC in combination with platinum doublet chemotherapy.
Arm 1 (Pembrolizumab (+) Berahyaluronidase alfa+ Platinum Doublet Chemotherapy)	Nab-paclitaxel	Participants with treatment-naïve metastatic NSCLC will receive pembrolizumab (+) berahyaluronidase alfa SC in combination with platinum doublet chemotherapy.
Arm 1 (Pembrolizumab (+) Berahyaluronidase alfa+ Platinum Doublet Chemotherapy)	Filgrastim	Participants with treatment-naïve metastatic NSCLC will receive pembrolizumab (+) berahyaluronidase alfa SC in combination with platinum doublet chemotherapy.
Arm 1 (Pembrolizumab (+) Berahyaluronidase alfa+ Platinum Doublet Chemotherapy)	Pegylated filgrastim	Participants with treatment-naïve metastatic NSCLC will receive pembrolizumab (+) berahyaluronidase alfa SC in combination with platinum doublet chemotherapy.
Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)	Pemetrexed	Participants with treatment-naïve metastatic NSCLC will receive Pembrolizumab IV in combination with platinum doublet chemotherapy.
Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)	Cisplatin	Participants with treatment-naïve metastatic NSCLC will receive Pembrolizumab IV in combination with platinum doublet chemotherapy.
Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)	Carboplatin	Participants with treatment-naïve metastatic NSCLC will receive Pembrolizumab IV in combination with platinum doublet chemotherapy.
Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)	Paclitaxel	Participants with treatment-naïve metastatic NSCLC will receive Pembrolizumab IV in combination with platinum doublet chemotherapy.
Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)	Nab-paclitaxel	Participants with treatment-naïve metastatic NSCLC will receive Pembrolizumab IV in combination with platinum doublet chemotherapy.
Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)	Pembrolizumab	Participants with treatment-naïve metastatic NSCLC will receive Pembrolizumab IV in combination with platinum doublet chemotherapy.
Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)	Filgrastim	Participants with treatment-naïve metastatic NSCLC will receive Pembrolizumab IV in combination with platinum doublet chemotherapy.
Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)	Pegylated filgrastim	Participants with treatment-naïve metastatic NSCLC will receive Pembrolizumab IV in combination with platinum doublet chemotherapy.

Primary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose	At designated time points (Up to ~14 months).	AUC is defined as area under curve exposure. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine AUC.
Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State	At designated time points (Up to ~18 months)	Ctrough is defined as the trough concentration at steady-state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough.

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC) of Pembrolizumab Measured at Steady State	At designated time points (Up to ~28 months)	AUC is defined as area under curve exposure at steady state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine AUC.
Maximum Serum Concentration (Cmax) of Pembrolizumab Measured After the First Dose	At designated time points (Up to ~28 months)	Cmax is defined as the peak concentration over the dosing interval. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax.
Trough Concentration (Ctrough) of Pembrolizumab Measured After the First Dose	At designated time points (Up to ~28 months)	Ctrough is defined as the trough concentration. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough.
Maximum Serum Concentration (Cmax) of Pembrolizumab Measured at Steady State	At designated time points (Up to ~28 months)	Cmax is defined as the peak concentration over the dosing interval in steady-state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax
Number of Participants Who Test Positive for Anti-Drug Antibodies (ADAs) for Pembrolizumab	At designated time points (Up to ~28 months)	Blood samples are to be collected at designated time points for the determination of the presence or absence of anti-pembrolizumab antibodies. The percentage of participants who develop anti pembrolizumab antibodies will be reported.
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)	Up to~60 months	The ORR is defined as the percentage of participants who achieve a confirmed CR or PR per RECIST 1.1 as assessed by BICR.
Progression-free Survival (PFS) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)	Up to~60 months	PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
Overall Survival (OS)	Up to~60 months	OS is defined as the time from randomization to death due to any cause.
Duration of Response (DOR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)	Up to~60 months	For participants who show confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Number of Participants Who Experienced at Least One Adverse Event (AE)	Up to~28 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. The number of participants with an AE will be reported for Arms 1 and 2.
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)	Up to~25 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. The number of participants who discontinue study treatment due to an AE will be reported for Arms 1 and 2.
Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Score-Items 29 and 30	Baseline and up to ~28 months	EORTC QLQ-C30 is a psychometrically and clinically validated instrument appropriate for assessing HRQoL in oncology studies. The EORTC QLQ-C30 is the most widely used cancer-specific HRQoL instrument, which contains 30 items and measures 5 functional dimensions (physical, role, emotional, cognitive and social), 3 symptom items (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and QoL scale. For the global health status or QoL and function scales, a higher value indicates a better level of function; for symptom scales and items, a higher value indicates increased severity of symptoms.
Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Physical Functioning Score-Items 1 to 5	Baseline and up to ~28 months	The EQ-5D-5L is a standardized instrument for use as a measure of health outcome and will provide data to develop health utilities for use in health economic analyses. The 5 health state dimensions in the EQ-5D-5L include the following: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension is rated on a 5-point scale from 1 (no problem) to 5 (unable to/extreme problems). The EQ-5D-5L also includes a graded (0 to 100) vertical visual analog scale on which the participant rates his or her general state of health at the time of the assessment. This instrument has been used extensively in cancer studies and published results from these studies support its validity and reliability.
Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Role Functioning Score-Items 6 and 7	Baseline and up to ~28 months	The EQ-5D-5L is a standardized instrument for use as a measure of health outcome and will provide data to develop health utilities for use in health economic analyses. The 5 health state dimensions in the EQ-5D-5L include the following: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension is rated on a 5-point scale from 1 (no problem) to 5 (unable to/extreme problems). The EQ-5D-5L also includes a graded (0 to 100) vertical visual analog scale on which the participant rates his or her general state of health at the time of the assessment. This instrument has been used extensively in cancer studies and published results from these studies support its validity and reliability.

Trial Locations

Locations (110)

Törökbálinti Tüdőgyógyintézet ( Site 2105); 🇭🇺 Törökbálint, Pest, Hungary

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 4207); 🇨🇳 Kaohsiung, Taiwan

St. Joseph's Hospital and Medical Center-Dignity Health Cancer Institute ( Site 0023); 🇺🇸 Phoenix, Arizona, United States

Hattiesburg Clinic Hematology/Oncology ( Site 0008); 🇺🇸 Hattiesburg, Mississippi, United States

Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 2603); 🇫🇷 Paris, France

Central Care Cancer Center - Bolivar ( Site 0017); 🇺🇸 Bolivar, Missouri, United States

Orchard Healthcare Research Inc. ( Site 0011); 🇺🇸 Skokie, Illinois, United States

Hospital de Câncer de Recife ( Site 1107); 🇧🇷 Recife, Pernambuco, Brazil

Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1210); 🇨🇱 Santiago, Region M. De Santiago, Chile

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2103); 🇭🇺 Szolnok, Jasz-Nagykun-Szolnok, Hungary

The First Affiliated Hospital of Xi'an Jiaotong University ( Site 4520); 🇨🇳 Xi'an, Shaanxi, China

Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 1100); 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Osaka International Cancer Institute ( Site 4407); 🇯🇵 Osaka, Japan

FALP-UIDO ( Site 1203); 🇨🇱 Santiago, Region M. De Santiago, Chile

Centre Hospitalier de Cornouaille Quimper - Concarneau ( Site 2600); 🇫🇷 Quimper, Finistere, France

Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1404); 🇬🇹 Ciudad de Guatemala, Guatemala

SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2303); 🇷🇴 Florești, Cluj, Romania

The Oncology Centre ( Site 2901); 🇿🇦 Durban, Kwazulu-Natal, South Africa

Centro Medico Integral De Cancerología (CEMIC) ( Site 1400); 🇬🇹 Quetzaltenango, Guatemala

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502); 🇹🇷 Istanbul, Turkey

Gunma Prefectural Cancer Center ( Site 4416); 🇯🇵 Otashi, Gunma, Japan

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2401); 🇪🇸 Madrid, Madrid, Comunidad De, Spain

CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2903); 🇿🇦 Port Elizabeth, Eastern Cape, South Africa

Institutul Oncologic-Oncologie Medicala ( Site 2302); 🇷🇴 Cluj, Romania

CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2404); 🇪🇸 Santiago de Compostela, La Coruna, Spain

Kansai Medical University Hospital ( Site 4408); 🇯🇵 Hirakata, Osaka, Japan

National Taiwan University Cancer Center (NTUCC) ( Site 4205); 🇨🇳 Taipei City, Taipei, Taiwan

Gulhane Egitim Arastirma Hastanesi-Oncology ( Site 2504); 🇹🇷 Ankara, Turkey

Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2301); 🇷🇴 Craiova, Dolj, Romania

Songklanagarind hospital ( Site 4302); 🇹🇭 Hatyai, Songkhla, Thailand

Memorial Kayseri Hastanesi ( Site 2500); 🇹🇷 Kayseri, Turkey

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2801); 🇵🇱 Koszalin, Zachodniopomorskie, Poland

Chulalongkorn University ( Site 4301); 🇹🇭 Bangkok, Krung Thep Maha Nakhon, Thailand

Hacettepe Universite Hastaneleri-oncology hospital ( Site 2506); 🇹🇷 Ankara, Turkey

Hospital Universitari Vall d'Hebron-Oncology ( Site 2400); 🇪🇸 Barcelona, Spain

İnönü Üniversitesi Turgut Özal Tıp Merkezi-medical oncology depertmant ( Site 2503); 🇹🇷 Malatya, Turkey

Beijing Cancer hospital-intrathoratic deparmtment II ( Site 4510); 🇨🇳 Beijing, Beijing, China

Anhui Provincial Hospital-Cancer Chemotherapy Department ( Site 4503); 🇨🇳 Hefei, Anhui, China

Beijing Peking Union Medical College Hospital-pneumology department ( Site 4501); 🇨🇳 Beijing, Beijing, China

Beijing Chest Hospital,Capital Medical University ( Site 4511); 🇨🇳 Beijing, Beijing, China

Chongqing Three Gorges Central Hospital ( Site 4516); 🇨🇳 Wanzhou, Chongqing, China

Fujian Provincial Cancer Hospital ( Site 4517); 🇨🇳 Fuzhou, Fujian, China

The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 4515); 🇨🇳 Nanchang, Jiangxi, China

Wuhan Union Hospital Cancer Center-Cancer center ( Site 4502); 🇨🇳 Wuhan, Hubei, China

Fudan University Shanghai Cancer Center-Oncology ( Site 4512); 🇨🇳 Shanghai, Shanghai, China

Shanxi Cancer Hospital ( Site 4521); 🇨🇳 Taiyuan, Shanxi, China

Tianjin Chest Hospital ( Site 4518); 🇨🇳 Tianjin, Tianjin, China

I.E.U. Medical Point Hastanesi-Oncology ( Site 2507); 🇹🇷 Izmir, Karsiyaka, Izmir, Turkey

Franciscan Health Lafayette East ( Site 0020); 🇺🇸 Lafayette, Indiana, United States

Clermont Oncology Center ( Site 0018); 🇺🇸 Clermont, Florida, United States

University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0022); 🇺🇸 Chicago, Illinois, United States

Mercy Health-Paducah Medical Oncology and Hematology ( Site 0006); 🇺🇸 Paducah, Kentucky, United States

Instituto Alexander Fleming ( Site 1008); 🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata ( Site 1001); 🇦🇷 Mar del Plata, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 1005); 🇦🇷 ABB, Caba, Argentina

Sanatorio Parque ( Site 1003); 🇦🇷 Rosario, Santa Fe, Argentina

Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1002); 🇦🇷 Buenos Aires, Argentina

Clinica Adventista Belgrano-Oncology ( Site 1004); 🇦🇷 Caba, Argentina

Hospital Italiano de Córdoba ( Site 1000); 🇦🇷 Cordoba, Argentina

IC La Serena Research ( Site 1207); 🇨🇱 La Serena, Coquimbo, Chile

Oncocentro Valdivia ( Site 1201); 🇨🇱 Valdivia, Los Rios, Chile

Oncovida ( Site 1209); 🇨🇱 Santiago, Region M. De Santiago, Chile

A. C. Camargo Cancer Center ( Site 1106); 🇧🇷 Sao Paulo, Brazil

Instituto Nacional del Cancer-CR Investigación ( Site 1211); 🇨🇱 Santiago, Region M. De Santiago, Chile

Bradfordhill-Clinical Area ( Site 1202); 🇨🇱 Santiago, Region M. De Santiago, Chile

Jiangmen Center Hospital ( Site 4509); 🇨🇳 Jiangmen, Guangdong, China

ShenZhen People's Hospital ( Site 4504); 🇨🇳 Shenzhen, Guangdong, China

Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 4514); 🇨🇳 Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province-Respiratory ( Site 4508); 🇨🇳 Taizhou, Zhejiang, China

Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 2602); 🇫🇷 Tours, Indre-et-Loire, France

Centro Regional de Sub Especialidades Médicas SA ( Site 1401); 🇬🇹 Quetzaltenango, Guatemala

MEDI-K CAYALA ( Site 1403); 🇬🇹 Guatemala, Guatemala

Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2102); 🇭🇺 Kecskemét, Bacs-Kiskun, Hungary

Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2100); 🇭🇺 Budapest, Hungary

Semmelweis Egyetem-Pulmonológiai Klinika ( Site 2104); 🇭🇺 Budapest, Hungary

Kanagawa Cardiovascular and Respiratory Center ( Site 4404); 🇯🇵 Yokohama, Kanagawa, Japan

National Hospital Organization Hokkaido Cancer Center ( Site 4415); 🇯🇵 Sapporo, Hokkaido, Japan

Kurashiki Central Hospital ( Site 4409); 🇯🇵 Kurashiki, Okayama, Japan

Saitama Prefectural Cancer Center ( Site 4402); 🇯🇵 Ina-machi, Saitama, Japan

Sendai Kousei Hospital ( Site 4400); 🇯🇵 Sendai, Miyagi, Japan

Miyagi Cancer Center ( Site 4401); 🇯🇵 Natori, Miyagi, Japan

Shizuoka Cancer Center ( Site 4405); 🇯🇵 Nagaizumi-cho,Sunto-gun, Shizuoka, Japan

National Hospital Organization Kyushu Medical Center ( Site 4411); 🇯🇵 Fukuoka, Japan

Juntendo University Hospital ( Site 4413); 🇯🇵 Bunkyo-ku, Tokyo, Japan

Tochigi Cancer Center ( Site 4417); 🇯🇵 Utsunomiya, Tochigi, Japan

National Hospital Organization Kyushu Cancer Center ( Site 4410); 🇯🇵 Fukuoka, Japan

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier; 🇵🇱 Warszawa, Mazowieckie, Poland

Nippon Medical School Hospital ( Site 4403); 🇯🇵 Tokyo, Japan

Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii; 🇵🇱 Olsztyn, Warminsko-mazurskie, Poland

Cabinet Medical Oncomed ( Site 2305); 🇷🇴 Timișoara, Timis, Romania

Medical Oncology Centre of Rosebank ( Site 2907); 🇿🇦 Johannesburg, Gauteng, South Africa

Steve Biko Academic Hospital-Medical Oncology ( Site 2904); 🇿🇦 Pretoria, Gauteng, South Africa

Cape Town Oncology Trials ( Site 2902); 🇿🇦 Cape Town, Western Cape, South Africa

Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2900); 🇿🇦 Sandton, Gauteng, South Africa

Changhua Christian Hospital ( Site 4203); 🇨🇳 Changhua County, Changhua, Taiwan

Chang Gung Memorial Hospital at Kaohsiung ( Site 4200); 🇨🇳 Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan

Hospital Universitario Juan Ramon Jimenez-Oncología Medica ( Site 2402); 🇪🇸 Huelva, Spain

E-Da hospital ( Site 4208); 🇨🇳 Kaohsiung, Taiwan

National Cheng Kung University Hospital ( Site 4202); 🇨🇳 Tainan, Taiwan

National Taiwan University Hospital-Oncology ( Site 4204); 🇨🇳 Taipei, Taiwan

Maharaj Nakorn Chiang Mai Hospital ( Site 4300); 🇹🇭 Muang, Chiang Mai, Thailand

Division of Medical Oncology, Siriraj H ( Site 4303); 🇹🇭 Siriraj, Krung Thep Maha Nakhon, Thailand

Ankara City Hospital-Medical Oncology ( Site 2501); 🇹🇷 Ankara, Turkey

Fujita Health University ( Site 4406); 🇯🇵 Toyoake, Aichi, Japan

Mid Florida Hematology and Oncology Center ( Site 0010); 🇺🇸 Orange City, Florida, United States

CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 1102); 🇧🇷 Fortaleza, Ceara, Brazil

Kurume University Hospital ( Site 4412); 🇯🇵 Kurume, Fukuoka, Japan

Osaka Medical and Pharmaceutical University Hospital ( Site 4414); 🇯🇵 Takatsuki, Osaka, Japan

Instituto Joinvilense de Hematologia e Oncologia ( Site 1101); 🇧🇷 Joinville, Santa Catarina, Brazil