MedPath

Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)

Phase 3
Recruiting
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
Registration Number
NCT05609968
Lead Sponsor
Merck Sharp & Dohme LLC
Brief Summary

The purpose of this study is to compare pembrolizumab (MK-3475) in combination with sacituzumab govitecan with pembrolizumab alone with respect to progression-free survival (PFS) and overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) among adults with metastatic non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%).

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
614
Inclusion Criteria

The main inclusion criteria include but are not limited to the following:

  • Has a histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC)
  • Has confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase 1 (ALK-1), or ROS proto-oncogene 1 (ROS-1)-directed therapy is not indicated as primary therapy
  • Has provided tumor tissue that demonstrates PD-L1 tumor proportion score (TPS) ≥50% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
  • Has a life expectancy of at least 3 months
Exclusion Criteria

The main exclusion criteria include but are not limited to the following:

  • Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years

  • Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC

  • Has previously received treatment with Topoisomerase 1 inhibitors or Trop-2 targeted therapy

  • Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti anti- programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor

  • Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicities requiring corticosteroids

  • Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months of the first dose of study intervention

  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

  • Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration

  • Has cardiac disease

    • Myocardial infarction or unstable angina pectoris within 6 months of enrollment
    • History of serious ventricular arrhythmia, high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications; history of QT interval prolongation
    • New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of <40%
  • Has active chronic inflammatory bowel disease

  • Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication

  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis

  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab or sacituzumab govitecan and/or any of their excipients

  • Has active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy

  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

  • Has active infection requiring systemic therapy

  • Has history of human immunodeficiency virus (HIV) infection

  • History of hepatitis B or known active hepatitis C virus infection

  • Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator

  • Have not adequately recovered from major surgery or have ongoing surgical complications

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Pembrolizumab + Sacituzumab GovitecanSacituzumab GovitecanParticipants receive sacituzumab govitecan 10mg/kg intravenous (IV) infusion once weekly on Day 1 and Day 8 of a continuous 21-day cycle until progressive disease (PD) requiring discontinuation, unacceptable toxicity, withdrawal of consent, or death. Participants receive pembrolizumab 200mg IV infusion on Day 1 every 3 weeks (Q3W) for up to 35 cycles (each cycle length = 21 days).
PembrolizumabPembrolizumabParticipants receive pembrolizumab 200mg IV infusion on Day 1 Q3W for up to 35 cycles (each cycle length = 21 days).
Pembrolizumab + Sacituzumab GovitecanPembrolizumabParticipants receive sacituzumab govitecan 10mg/kg intravenous (IV) infusion once weekly on Day 1 and Day 8 of a continuous 21-day cycle until progressive disease (PD) requiring discontinuation, unacceptable toxicity, withdrawal of consent, or death. Participants receive pembrolizumab 200mg IV infusion on Day 1 every 3 weeks (Q3W) for up to 35 cycles (each cycle length = 21 days).
Primary Outcome Measures
NameTimeMethod
Overall Survival (OS)Up to approximately 48 months

OS is defined as the time from randomization to death due to any cause.

Progression-Free Survival (PFS)Up to approximately 34 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 per the 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. RECIST 1.1 is modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. PFS as assessed by blinded independent central review (BICR) will be presented.

Secondary Outcome Measures
NameTimeMethod
Duration of Response (DOR)Up to approximately 48 months

DOR is defined as the time from the first documented evidence of a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until Progressive Disease (PD) or death due to any cause, whichever occurs first, in participants demonstrating a CR or PR. 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.

Objective Response (OR)Up to approximately 34 months

OR is defined as the confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by BICR.

Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)Baseline and up to approximately 48 months

The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" will be scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better overall health status. Per protocol, the change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.

Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30Baseline and up to approximately 48 months

The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better level of physical functioning. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.

Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30Up to approximately 48 months

The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") will be scored on a 7-point scale (1=Very Poor to 7=Excellent). Higher scores indicate a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented.

Change from Baseline in Role Functioning (Items 6-7) Combined Score on the EORTC QLQ-C30Baseline and up to approximately 48 months

The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a better level of role functioning. Change from baseline in the role functioning (EORTC QLQ-C30 Items 6-7) combined score will be presented.

Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30Baseline and up to approximately 48 months

The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicates a worse level of dyspnea. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score will be presented.

Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13)Baseline and up to approximately 48 months

The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "How much did you cough?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate more frequent coughing and a worse outcome. The change from baseline in cough (EORTC QLQ-LC13 Item 31) score will be presented.

Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13Baseline and up to approximately 48 months

The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate worse level of chest pain. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented.

Number of Participants Who Experience an Adverse Event (AE)Up to approximately 48 months

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study intervention. Per protocol, the number of participants who experience an AE will be reported.

Number of Participants Who Discontinue Study Treatment Due To an AEUp to approximately 48 months

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study intervention. Per protocol, the number of participants who discontinue study treatment due to an AE will be reported.

TTD in Role Functioning (Items 6-7) Combined Score on the EORTC QLQ-C30Up to approximately 48 months

The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a better level of role functioning. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented.

TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30Up to approximately 48 months

The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better level of physical functioning. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented.

TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 11Up to approximately 48 months

The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. TTD in the score of EORTC QLQ-C30 Item 8 will be presented.

TTD in Cough Score (Item 31) on the EORTC QLQ-LC13Up to approximately 48 months

The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "How much did you cough?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate more frequent coughing and a worse outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. TTD in the score of EORTC QLQ-LC13 Item 31 will be presented.

TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13Up to approximately 48 months

The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline. TTD in the score of EORTC QLQ-LC13 Item 40 will be presented.

Trial Locations

Locations (166)

Houston Methodist Hospital ( Site 0419)

🇺🇸

Houston, Texas, United States

Cardiomed SRL Cluj-Napoca ( Site 0217)

🇷🇴

Cluj-Napoca, Cluj, Romania

Infirmary Cancer Care ( Site 0418)

🇺🇸

Mobile, Alabama, United States

Clermont Oncology Center ( Site 0421)

🇺🇸

Clermont, Florida, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0417)

🇺🇸

Miami, Florida, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0407)

🇺🇸

Marietta, Georgia, United States

Mid Florida Hematology and Oncology Center ( Site 0416)

🇺🇸

Orange City, Florida, United States

White Plains Hospital-Center for Cancer Care ( Site 0403)

🇺🇸

White Plains, New York, United States

Central Texas Veterans health care ( Site 0414)

🇺🇸

Temple, Texas, United States

Cancer Research SA-St Andrews Hospital ( Site 0603)

🇦🇺

Adelaide, South Australia, Australia

Orange Hospital-Clinical Trials Unit ( Site 0600)

🇦🇺

Orange, New South Wales, Australia

CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0320)

🇧🇷

Fortaleza, Ceara, Brazil

Hospital Tacchini ( Site 0322)

🇧🇷

Bento Goncalves, Rio Grande Do Sul, Brazil

A. C. Camargo Cancer Center ( Site 0324)

🇧🇷

Sao Paulo, Brazil

Southlake Regional Health Centre-Oncology Clinical Trials ( Site 0435)

🇨🇦

Newmarket, Ontario, Canada

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0318)

🇧🇷

Barretos, Sao Paulo, Brazil

Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0430)

🇨🇦

Greenfield Park, Quebec, Canada

North Estonia Medical Centre Foundation-Chemotherapy ( Site 0621)

🇪🇪

Tallinn, Harjumaa, Estonia

Tartu University Hospital-Radiotherapy and oncology ( Site 0620)

🇪🇪

Tartu, Tartumaa, Estonia

Universitätsmedizin Mannheim ( Site 0654)

🇩🇪

Mannheim, Baden-Wurttemberg, Germany

Klinikum Kempten ( Site 0655)

🇩🇪

Kempten, Bayern, Germany

Klinikum Würzburg Mitte ( Site 0651)

🇩🇪

Wuerzburg, Bayern, Germany

Katholisches Klinikum Koblenz ( Site 0650)

🇩🇪

Koblenz, Rheinland-Pfalz, Germany

Krankenhaus Martha-Maria Halle-Dölau-Klinik für Innere Medizin II ( Site 0657)

🇩🇪

Halle, Sachsen-Anhalt, Germany

Vivantes Hospital Spandau-Klinik für Innere Medizin, Hämatologie, Onkologie und Gastroenterologie- (

🇩🇪

Berlin, Germany

Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 0141)

🇬🇷

Athens, Attiki, Greece

Helios Klinikum Emil von Behring Berlin-Zehlendorf-Lungenklinik Heckeshorn ( Site 0653)

🇩🇪

Berlin, Germany

Sotiria Thoracic Diseases Hospital of Athens-3rd Dept of Internal Medicine, Oncology Unit ( Site 014

🇬🇷

Athens, Attiki, Greece

Shaare Zedek Medical Center-Oncology ( Site 0176)

🇮🇱

Jerusalem, Israel

European Interbalkan Medical Center-Oncology Department ( Site 0142)

🇬🇷

Thessaloniki, Greece

Sourasky Medical Center-Oncology ( Site 0175)

🇮🇱

Tel Aviv, Israel

Yitzhak Shamir Medical Center. ( Site 0179)

🇮🇱

Zerifin, Israel

Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0677)

🇮🇹

Roma, Lazio, Italy

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 0674)

🇮🇹

Bergamo, Lombardia, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0673)

🇮🇹

Milan, Lombardia, Italy

Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 0671)

🇮🇹

Naples, Napoli, Italy

Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 0675)

🇮🇹

Firenze, Toscana, Italy

Azienda Ospedaliero Universitaria di Parma-UO Oncologia Medica ( Site 0676)

🇮🇹

Parma, Italy

Aichi Cancer Center Hospital ( Site 0018)

🇯🇵

Nagoya, Aichi, Japan

Kurume University Hospital ( Site 0014)

🇯🇵

Kurume, Fukuoka, Japan

Miyagi Cancer Center ( Site 0001)

🇯🇵

Natori, Miyagi, Japan

Niigata Cancer Center Hospital ( Site 0017)

🇯🇵

Niigata-shi, Niigata, Japan

Kansai Medical University Hospital ( Site 0005)

🇯🇵

Hirakata, Osaka, Japan

Okayama University Hospital ( Site 0007)

🇯🇵

Okayama, Japan

Wakayama Medical University Hospital ( Site 0006)

🇯🇵

Wakayama, Japan

Chonnam National University Hwasun Hospital-Pulmonology ( Site 0061)

🇰🇷

Hwasun, Jeonranamdo, Korea, Republic of

Pusan National University Yangsan Hospital ( Site 0060)

🇰🇷

Busan, Kyongsangnam-do, Korea, Republic of

Med-Polonia Sp. z o. o. ( Site 0204)

🇵🇱

Poznan, Wielkopolskie, Poland

Chungnam national university hospital-Department of Internal Medicine ( Site 0063)

🇰🇷

Daejeon, Taejon-Kwangyokshi, Korea, Republic of

Asan Medical Center ( Site 0064)

🇰🇷

Seoul, Korea, Republic of

Korea University Guro Hospital-Internal Medicine ( Site 0062)

🇰🇷

Seoul, Korea, Republic of

Pauls Stradins Clinical Univeristy Hospital-Chemotherapy department ( Site 0192)

🇱🇻

Riga, Latvia

Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 0692)

🇱🇹

Kaunas, Kauno Apskritis, Lithuania

Hospital Raja Perempuan Zainab II-Medical Department ( Site 0035)

🇲🇾

Kota Bharu, Kelantan, Malaysia

Gral Medical SRL-Medical Oncology ( Site 0220)

🇷🇴

București, Bucuresti, Romania

Hospital Pulau Pinang-Oncology, radiotherapy and palliat ( Site 0034)

🇲🇾

George Town, Pulau Pinang, Malaysia

Clínica Internacional - Sede San Borja ( Site 0356)

🇵🇪

Lima, Peru

Cebu Doctors University Hospital ( Site 0045)

🇵🇭

Cebu, Philippines

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier

🇵🇱

Warszawa, Mazowieckie, Poland

Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 0202)

🇵🇱

Prabuty, Pomorskie, Poland

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0201)

🇵🇱

Siedlce, Mazowieckie, Poland

Szpital Rejonowy im. dr. J. Rostka w Raciborzu ( Site 0207)

🇵🇱

Racibórz, Slaskie, Poland

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0203)

🇵🇱

Przemysl, Podkarpackie, Poland

Amethyst Radiotherapy Center-Oncologie Medicala ( Site 0216)

🇷🇴

Florești, Cluj, Romania

Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 0215)

🇷🇴

Craiova, Dolj, Romania

Cabinet Medical Oncomed ( Site 0219)

🇷🇴

Timișoara, Timis, Romania

Institutul Oncologic-Oncologie Medicala ( Site 0218)

🇷🇴

Cluj, Romania

National Taiwan University Cancer Center (NTUCC) ( Site 0079)

🇨🇳

Taipei City, Taipei, Taiwan

Maharaj Nakorn Chiang Mai Hospital ( Site 0092)

🇹🇭

Muang, Chiang Mai, Thailand

Songklanagarind hospital ( Site 0091)

🇹🇭

Hatyai, Songkhla, Thailand

Sunpasitthiprasong Hospital ( Site 0093)

🇹🇭

Ubon Ratchathani, Thailand

Hacettepe Universite Hastaneleri-oncology hospital ( Site 0265)

🇹🇷

Ankara, Turkey

Liv Hospital Ankara-Oncology ( Site 0274)

🇹🇷

Ankara, Turkey

Ankara City Hospital-Medical Oncology ( Site 0268)

🇹🇷

Ankara, Turkey

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0267)

🇹🇷

Istanbul, Turkey

Trakya University-Medical Oncology ( Site 0270)

🇹🇷

Edirne, Turkey

Mersin Sehir Eğitim ve Araştırma Hastanesi ( Site 0275)

🇹🇷

Mersin, Turkey

VM Medical Park Pendik Hospital ( Site 0271)

🇹🇷

Istanbul, Turkey

University College London Hospital ( Site 0305)

🇬🇧

London, England, United Kingdom

The Clatterbridge Cancer Centre ( Site 0303)

🇬🇧

Wirral, United Kingdom

St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 0302)

🇬🇧

London, London, City Of, United Kingdom

Second Affiliated hospital of Anhui Medical University ( Site 0126)

🇨🇳

Hefei, Anhui, China

Anhui Provincial Hospital ( Site 0136)

🇨🇳

Hefei, Anhui, China

Beijing Cancer hospital ( Site 0104)

🇨🇳

Beijing, Beijing, China

Chongqing University Cancer Hospital-Medical Oncology ( Site 0130)

🇨🇳

Chongqing, Chongqing, China

Fujian Provincial Cancer Hospital ( Site 0131)

🇨🇳

Fuzhou, Fujian, China

The First Affiliated hospital of Xiamen University ( Site 0132)

🇨🇳

Xiamen, Fujian, China

Beijing Peking Union Medical College Hospital-pneumology department ( Site 0106)

🇨🇳

Beijing, Beijing, China

Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (

🇨🇳

Guangzhou, Guangdong, China

Beijing Chest Hospital,Capital Medical University ( Site 0105)

🇨🇳

Beijing, Beijing, China

Guangxi Medical University Affiliated Tumor Hospital-Respiratory Oncology ( Site 0113)

🇨🇳

Nanning, Guangxi, China

Harbin Medical University Cancer Hospital ( Site 0119)

🇨🇳

Harbin, Heilongjiang, China

Henan Cancer Hospital ( Site 0127)

🇨🇳

Zhengzhou, Henan, China

Tongji Hospital Tongji Medical,Science & Technology ( Site 0116)

🇨🇳

Wuhan, Hubei, China

Xiangya Hospital Central South University ( Site 0124)

🇨🇳

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University ( Site 0135)

🇨🇳

Changsha, Hunan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0115)

🇨🇳

Wuhan, Hubei, China

Hubei Cancer Hospital ( Site 0107)

🇨🇳

Wuhan, Hubei, China

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0112

🇨🇳

NanJing, Jiangsu, China

Nantong Tumor Hospital-Medical Oncology ( Site 0122)

🇨🇳

Nantong, Jiangsu, China

The First Affliated Hospital of Suzhou University ( Site 0114)

🇨🇳

Suzhou, Jiangsu, China

The Second Affiliated Hospital of Nanchang University ( Site 0134)

🇨🇳

Nanchang, Jiangxi, China

The First Hospital of Jilin University ( Site 0117)

🇨🇳

Changchun, Jilin, China

Jilin Province Tumor Hospital ( Site 0118)

🇨🇳

Changchun, Jilin, China

The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 0133)

🇨🇳

Xi'an, Shaanxi, China

Jinan Central Hospital-oncology department ( Site 0121)

🇨🇳

Jinan, Shandong, China

LinYi Cancer Hospital ( Site 0120)

🇨🇳

Linyi, Shandong, China

Shanghai Chest Hospital ( Site 0101)

🇨🇳

Shanghai, Shanghai, China

Fudan University Shanghai Cancer Center-Oncology ( Site 0102)

🇨🇳

Shanghai, Shanghai, China

West China Hospital of Sichuan University ( Site 0129)

🇨🇳

Cheng Du, Sichuan, China

Sichuan Cancer hospital ( Site 0128)

🇨🇳

Chengdu, Sichuan, China

Huashan Hospital, Fudan University ( Site 0103)

🇨🇳

Shanghai, Shanghai, China

The First Affiliated Hospital, Zhejiang University ( Site 0109)

🇨🇳

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital-Medical Oncology ( Site 0111)

🇨🇳

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital ( Site 0108)

🇨🇳

Hangzhou, Zhejiang, China

The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0110)

🇨🇳

Hangzhou, Zhejiang, China

Our Lady of the Lake RMC ( Site 0424)

🇺🇸

Baton Rouge, Louisiana, United States

St. Marys Hospital Center-Oncology ( Site 0434)

🇨🇦

Montreal, Quebec, Canada

Kindai University Hospital- Osakasayama Campus ( Site 0013)

🇯🇵

Osaka-sayama, Osaka, Japan

Rabin Medical Center-Oncology ( Site 0174)

🇮🇱

Petah Tikva, Israel

Kanagawa cancer center ( Site 0016)

🇯🇵

Yokohama, Kanagawa, Japan

Sendai Kousei Hospital ( Site 0012)

🇯🇵

Sendai, Miyagi, Japan

Kyushu University Hospital ( Site 0010)

🇯🇵

Fukuoka, Japan

RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia-Out-patient and Day patient facility of Ch

🇱🇻

Riga, Latvia

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0208)

🇵🇱

Bydgoszcz, Kujawsko-pomorskie, Poland

Frankston Hospital-Oncology and Haematology ( Site 0601)

🇦🇺

Frankston, Victoria, Australia

BC Cancer Abbotsford-Medical Oncology ( Site 0433)

🇨🇦

Abbotsford, British Columbia, Canada

Centre integre universitaire de sante et de services sociaux-oncology ( Site 0431)

🇨🇦

Trois-Rivières, Quebec, Canada

Oncovida ( Site 0334)

🇨🇱

Santiago, Region M. De Santiago, Chile

Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0332)

🇨🇱

Santiago, Region M. De Santiago, Chile

Meir Medical Center-oncology ( Site 0171)

🇮🇱

KfarSaba, Israel

National Hospital Organization Shikoku Cancer Center ( Site 0008)

🇯🇵

Matsuyama, Ehime, Japan

Kurashiki Central Hospital ( Site 0011)

🇯🇵

Kurashiki, Okayama, Japan

Hospital Cayetano Heredia ( Site 0361)

🇵🇪

Lima, Peru

Kanazawa University Hospital ( Site 0019)

🇯🇵

Kanazawa, Ishikawa, Japan

Saitama Prefectural Cancer Center ( Site 0002)

🇯🇵

Ina-machi, Saitama, Japan

Daugavpils Regional Hospital-Oncology Department ( Site 0194)

🇱🇻

Daugavpils, Daugavpils Novads, Latvia

Clinica Vallesur - AUNA ( Site 0360)

🇵🇪

Arequipa, Ariqipa, Peru

Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 0362)

🇵🇪

Concepcion, Junin, Peru

ST. LUKE'S MEDICAL CENTER ( Site 0046)

🇵🇭

Quezon City, National Capital Region, Philippines

Shizuoka Cancer Center ( Site 0004)

🇯🇵

Nagaizumi-cho,Sunto-gun, Shizuoka, Japan

National Hospital Organization Kyushu Medical Center ( Site 0009)

🇯🇵

Fukuoka, Japan

Liepjas reionl slimnca ( Site 0191)

🇱🇻

Liepaja, Latvia

National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 0691)

🇱🇹

Vilnius, Vilniaus Miestas, Lithuania

National Cheng Kung University Hospital-Clinical Trial Center ( Site 0076)

🇨🇳

Tainan, Taiwan

National Taiwan University Hospital-Internal Medicine ( Site 0080)

🇨🇳

Taipei, Taiwan

Nippon Medical School Hospital ( Site 0003)

🇯🇵

Tokyo, Japan

Beacon Hospital Sdn Bhd ( Site 0033)

🇲🇾

Petaling Jaya, Selangor, Malaysia

Detecta Clínica ( Site 0364)

🇵🇪

Surquillo, Lima, Peru

Metro Davao Medical and Research Center ( Site 0047)

🇵🇭

Davao City, Davao Del Sur, Philippines

Centro de investigacion Clínica Trujillo ( Site 0358)

🇵🇪

Trujillo, La Libertad, Peru

Chung Shan Medical University Hospital ( Site 0078)

🇨🇳

Taichung City, Taichung, Taiwan

E-Da hospital ( Site 0075)

🇨🇳

Kaohsiung, Taiwan

Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 0097)

🇹🇭

Bangkok, Krung Thep Maha Nakhon, Thailand

Chang Gung Medical Foundation-Linkou Branch ( Site 0082)

🇨🇳

Taoyuan, Taiwan

Faculty of Medicine Siriraj Hospital ( Site 0090)

🇹🇭

Bangkok, Krung Thep Maha Nakhon, Thailand

Lampang Cancer Hospital ( Site 0098)

🇹🇭

Mueang Lampang, Lampang, Thailand

Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 0300)

🇬🇧

Leicester, Leicestershire, United Kingdom

Casa di Cura Dott. Pederzoli-LUNG-UNIT TORACIC ( Site 0670)

🇮🇹

Peschiera del Garda, Verona, Italy

Hospital da Cidade de Passo Fundo ( Site 0321)

🇧🇷

Passo Fundo, Rio Grande Do Sul, Brazil

Instituto de Oncologia Saint Gallen ( Site 0317)

🇧🇷

Santa Cruz do Sul, Rio Grande Do Sul, Brazil

Henry Ford Hospital ( Site 0412)

🇺🇸

Detroit, Michigan, United States

Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0425)

🇺🇸

Minneapolis, Minnesota, United States

Kaiser Permanente Northwest-Central Interstate--Oncology ( Site 0408)

🇺🇸

Portland, Oregon, United States

I.E.U. Medical Point Hastanesi-Oncology ( Site 0266)

🇹🇷

Izmir, Turkey

Takarazuka City Hospital ( Site 0015)

🇯🇵

Takarazuka, Hyogo, Japan

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