Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)

Phase 3

Recruiting

• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Interventions: Biological: Sacituzumab tirumotecan; Biological: Pembrolizumab

• Registration Number: NCT06170788
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS.

All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-03
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-14
• Study Start: 2023-12-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-06
• Primary Completion: 2028-01-25
• Study Completion: 2030-05-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 614

Inclusion Criteria

• Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC

  • Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy
  • Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.
  • A life expectancy of at least 3 months.
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)

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Exclusion Criteria

• Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
• Has Grade ≥2 peripheral neuropathy.
• History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
• Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.
• Received prior systemic anticancer therapy for their metastatic NSCLC.
• Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
• Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
• Received radiation therapy to the lung that is >30 Gy within 6 months of start of study intervention.
• Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
• Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
• Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
• Known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Known intolerance to sacituzumab tirumotecan or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary.
• Known hypersensitivity to sacituzumab tirumotecan or other biologic therapy.
• Active autoimmune disease that has required systemic treatment in the past 2 years.
• History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
• Active infection requiring systemic therapy
• Concurrent active Hepatitis B and Hepatitis C virus infection.
• Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
• History of allogeneic tissue/solid organ transplant.
• Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pembrolizumab + Sacituzumab tirumotecan	Sacituzumab tirumotecan	Participants receive sacituzumab tirumotecan via intravenous (IV) infusion on Days 1, 15 and 29 of each 6-week cycle + 400 mg Pembrolizumab every 6 weeks (q6w) via IV infusion on Day 1 of each 6-week cycle for 18 cycles. Additionally, participants receive diphenhydramine (or equivalent), an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of sacituzumab tirumotecan. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator.
Pembrolizumab + Sacituzumab tirumotecan	Pembrolizumab	Participants receive sacituzumab tirumotecan via intravenous (IV) infusion on Days 1, 15 and 29 of each 6-week cycle + 400 mg Pembrolizumab every 6 weeks (q6w) via IV infusion on Day 1 of each 6-week cycle for 18 cycles. Additionally, participants receive diphenhydramine (or equivalent), an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of sacituzumab tirumotecan. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator.
Pembrolizumab	Pembrolizumab	Participants receive 400 mg Pembrolizumab via IV infusion q6w on Day 1 of each 6-week cycle for 18 cycles

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to approximately 48 months	OS is defined as the time from randomization to death from any cause.

Secondary Outcome Measures

Name	Time	Method
Time to Deterioration (TTD) Based on Change From Baseline in Chest Pain Score (EORTC QLQ-LC13 Item 40)	Up to approximately 24 months	The TTD in Chest Pain score (EORTC QLQ-LC13 Item 40) will be presented. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is assessed based on the time to a negative change (increase in score) from baseline. A longer TTD indicates a better outcome.
Percentage of Participants That Experience at Least 1 Adverse Event	Up to approximately 27 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. The percentage of participants who experience an AE will be presented.
Objective Response (OR)	Up to approximately 48 months	The OR is defined as a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by BICR.
Duration of Response (DOR)	Up to approximately 48 months	For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, duration of response 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.
Percentage of Participants Who Discontinue Study Treatment Due to an AE	Up to approximately 24 months	The percentage of participants who discontinue study treatment due to an AE will be presented.
Change From Baseline in Cough (EORTC QLQ-LC13 Item 31) Score	Baseline and up to approximately 24 months	Change from baseline in the score of EORTC QLQ-C13 Item 31 will be presented. The EORTC QLQ-C13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.
Progression free survival (PFS)	Up to approximately 48 months	PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first
Time to Deterioration (TTD) Based on Change From Baseline in Cough Score (EORTC QLQ-LC13 Item 31).	Up to approximately 24 months	The TTD in Cough score (EORTC QLQ-LC13 Item 31) will be presented. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is assessed based on the time to a negative change (increase in score) from baseline. A longer TTD indicates a better outcome.
Change from Baseline in Global Health Status/Quality of Life (QOL) [European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) 29 Items and 30] Score	Baseline and up to approximately 24 months	Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. 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?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.
Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score	Baseline and up to approximately 24 months	Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.
Change From Baseline in Chest Pain (EORTC QLQ-LC13 item 40) Score	Baseline and up to approximately 24 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. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. A lower score indicates a better outcome.
Time to Deterioration (TTD) Based on Change From Baseline in Global Health Status (GHS)/ QOL Score (EORTC QLQ-C30 Item 29 and 30)	Up to approximately 24 months	The TTD in GHS/QOL score (EORTC QLQ-C30 Items 29 and 30) will be presented. 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?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD as assessed based on a negative change (decrease in score) from Baseline in GHS/QOL score. A longer TTD indicates a better outcome.
Time to Deterioration (TTD) Based on Change From Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)	Up to approximately 24 months	The TTD in Dyspnea score (EORTC QLQ-C30 Item 8) will be presented. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is assessed based on the time to a negative change (increase in score) from baseline. A longer TTD indicates a better outcome.

Trial Locations

Locations (166)

Kanagawa Cancer Center ( Site 3408); 🇯🇵 Yokohama, Kanagawa, Japan

Niigata Cancer Center Hospital ( Site 3409); 🇯🇵 Niigata, Saitama, Japan

The Cancer Institute Hospital of JFCR ( Site 3404); 🇯🇵 Koto, Tokyo, Japan

Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130); 🇺🇸 Burbank, California, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0106); 🇺🇸 Marietta, Georgia, United States

The University of Louisville, James Graham Brown Cancer Center ( Site 0121); 🇺🇸 Louisville, Kentucky, United States

New England Cancer Specialists ( Site 0143); 🇺🇸 Scarborough, Maine, United States

Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0115); 🇺🇸 Minneapolis, Minnesota, United States

Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3002); 🇦🇺 Port Macquarie, New South Wales, Australia

Westmead Hospital-Department of Medical Oncology ( Site 3000); 🇦🇺 Westmead, New South Wales, Australia

Grampians Health-Medical Oncology ( Site 3001); 🇦🇺 Ballarat Central, Victoria, Australia

Northern Hospital ( Site 3003); 🇦🇺 Epping, Victoria, Australia

University of Massachusetts Chan Medical School-Division of Hematology/Oncology ( Site 0144); 🇺🇸 Worcester, Massachusetts, United States

Hattiesburg Clinic Hematology/Oncology ( Site 0104); 🇺🇸 Hattiesburg, Mississippi, United States

Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0134); 🇺🇸 Reno, Nevada, United States

University Hospitals Cleveland Medical Center ( Site 0119); 🇺🇸 Cleveland, Ohio, United States

Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0117); 🇺🇸 Corvallis, Oregon, United States

Oncology Consultants P.A. ( Site 0129); 🇺🇸 Houston, Texas, United States

Instituto Alexander Fleming ( Site 0306); 🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Hospital Británico de Buenos Aires-Oncology ( Site 0304); 🇦🇷 Ciudad autónoma de Buenos Aires, Caba, Argentina

Centro Privado de RMI Río Cuarto S.A. II ( Site 0310); 🇦🇷 Río Cuarto, Cordoba, Argentina

Instituto de Oncología de Rosario ( Site 0301); 🇦🇷 Rosario, Santa Fe, Argentina

Hospital Aleman-Oncology ( Site 0300); 🇦🇷 Buenos Aires, Argentina

Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0409); 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Clinica Viver ( Site 0400); 🇧🇷 Santa Maria, Rio Grande Do Sul, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0402); 🇧🇷 Barretos, Sao Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0406); 🇧🇷 São José do Rio Preto, Sao Paulo, Brazil

Instituto Nacional de Câncer - INCA ( Site 0405); 🇧🇷 Rio de Janeiro, Brazil

Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0401); 🇧🇷 Sao Paulo, Brazil

William Osler Health System ( Site 0203); 🇨🇦 Brampton, Ontario, Canada

Trillium Health Partners - Credit Valley Hospital ( Site 0202); 🇨🇦 Mississauga, Ontario, Canada

Clinica Universidad Catolica del Maule-Oncology ( Site 0501); 🇨🇱 Talca, Maule, Chile

Xiangyang Central Hospital-oncology department ( Site 3136); 🇨🇳 Xiangyang, Hubei, China

The Affiliated Hospital of Xuzhou Medical College ( Site 3112); 🇨🇳 Xuzhou, Jiangsu, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 3111); 🇨🇳 Hangzhou, Zhejiang, China

McGill University Health Centre ( Site 0200); 🇨🇦 Montréal, Quebec, Canada

FALP-UIDO ( Site 0509); 🇨🇱 Santiago, Region M. De Santiago, Chile

Orlandi Oncologia-Oncology ( Site 0504); 🇨🇱 Santiago, Region M. De Santiago, Chile

Bradfordhill-Clinical Area ( Site 0507); 🇨🇱 Santiago, Region M. De Santiago, Chile

The First Affiliated Hospital of Guangzhou Medical University ( Site 3134); 🇨🇳 Guangzhou, Guangdong, China

Second Affiliated hospital of Anhui Medical University ( Site 3133); 🇨🇳 Hefei, Anhui, China

Beijing Peking Union Medical College Hospital-pneumology department ( Site 3100); 🇨🇳 Beijing, Beijing, China

Beijing Cancer hospital-intrathoratic deparmtment II ( Site 3101); 🇨🇳 Beijing, Beijing, China

Fujian Provincial Cancer Hospital ( Site 3131); 🇨🇳 Fuzhou, Fujian, China

The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 3107); 🇨🇳 Xiamen, Fujian, China

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

Affiliated Hospital of Guangdong Medical University ( Site 3123); 🇨🇳 Zhanjiang, Guangdong, China

The Second Hospital of Hebei Medical University ( Site 3135); 🇨🇳 Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital-oncology of department ( Site 3132); 🇨🇳 Harbin, Heilongjiang, China

Henan Cancer Hospital ( Site 3116); 🇨🇳 Zhengzhou, Henan, China

Tongji Hospital Tongji Medical,Science & Technology ( Site 3117); 🇨🇳 Wuhan, Hubei, China

Wuhan Union Hospital Cancer Center-Cancer center ( Site 3130); 🇨🇳 Wuhan, Hubei, China

Hubei Cancer Hospital ( Site 3106); 🇨🇳 Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University ( Site 3138); 🇨🇳 Changsha, Hunan, China

Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3113); 🇨🇳 Wuxi, Jiangsu, China

The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 3127); 🇨🇳 Nanchang, Jiangxi, China

The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 3121); 🇨🇳 Nanchang, Jiangxi, China

Jilin Province Tumor Hospital-oncology department ( Site 3126); 🇨🇳 Changchun, Jilin, China

Jinan Central Hospital-oncology department ( Site 3122); 🇨🇳 Jinan, Shandong, China

West China Hospital, Sichuan University ( Site 3124); 🇨🇳 Cheng Du, Sichuan, China

Sichuan Cancer hospital. ( Site 3105); 🇨🇳 Chengdu, Sichuan, China

The Second People's Hospital of Neijiang ( Site 3140); 🇨🇳 Neijiang, Sichuan, China

Aalborg Universitetshospital, Syd-Department of Oncology ( Site 1201); 🇩🇰 Aalborg, Nordjylland, Denmark

Odense Universitetshospital ( Site 1200); 🇩🇰 Odense C, Syddanmark, Denmark

Jiangxi Provincial Cancer Hospital ( Site 3143); 🇨🇳 Nanchang, Jiangxi, China

Shandong Cancer Hospital ( Site 3119); 🇨🇳 Jinan, Shandong, China

Shanghai Changhai Hospital ( Site 3125); 🇨🇳 Shanghai, Shanghai, China

Yunnan Province Cancer Hospital ( Site 3139); 🇨🇳 Kunming, Yunnan, China

The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3115); 🇨🇳 Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province-Respiratory ( Site 3114); 🇨🇳 Taizhou, Zhejiang, China

Oncomedica S.A.S ( Site 0602); 🇨🇴 Montería, Cordoba, Colombia

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

Oncologos del Occidente ( Site 0603); 🇨🇴 Pereira, Risaralda, Colombia

Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni oddeleni ( Site 1103); 🇨🇿 Ostrava, Ostrava Mesto, Czechia

Vseobecna fakultni nemocnice v Praze-Onkologicka klinika ( Site 1106); 🇨🇿 Praha, Praha 2, Czechia

Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 1102); 🇨🇿 Olomouc, Czechia

Regionshospitalet Gødstrup-Kræftklinikken ( Site 1204); 🇩🇰 Herning, Midtjylland, Denmark

Centre d'Oncologie de Gentilly ( Site 1301); 🇫🇷 Nancy, Meurthe-et-Moselle, France

Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 1305); 🇫🇷 Poitiers, Vienne, France

Instituto Tumori Giovanni Paolo II-SSD Oncologia Medica per la Patologia Toracica ( Site 1804); 🇮🇹 Bari, Puglia, Italy

Asan Medical Center-Lung Cancer Center ( Site 3805); 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center-Division of Hematology/Oncology ( Site 3802); 🇰🇷 Seoul, Korea, Republic of

Higiea Oncologia ( Site 0721); 🇲🇽 Mexico City, Distrito Federal, Mexico

CIO - Centro de Inmuno-Oncología de Occidente ( Site 0715); 🇲🇽 Guadalajara, Jalisco, Mexico

Hôpital Saint Joseph-ONCOLOGY ( Site 1308); 🇫🇷 Marseille, Bouches-du-Rhone, France

Institut Régional du Cancer Montpellier-Medical Oncology ( Site 1309); 🇫🇷 Montpellier, Herault, France

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané; 🇫🇷 Limoges, Limousin, France

L HOPITAL NORD OUEST ( Site 1310); 🇫🇷 Gleize, Rhone, France

Centre Hospitalier de la Côte Basque ( Site 1300); 🇫🇷 Bayonne, Pyrenees-Atlantiques, France

Clinique de l'Europe-Service de pneumologie ( Site 1304); 🇫🇷 Amiens, Somme, France

AOU Renato Dulbecco ( Site 1801); 🇮🇹 Catanzaro, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1806); 🇮🇹 Roma, Italy

Osaka Medical and Pharmaceutical University Hospital ( Site 3413); 🇯🇵 Takatsuki, Osaka, Japan

Osaka International Cancer Institute ( Site 3414); 🇯🇵 Osaka, Japan

Chungbuk National University Hospital-Internal medicine ( Site 3804); 🇰🇷 Cheongju-si, Chungbuk, Korea, Republic of

Wonju Severance Christian Hospital ( Site 3808); 🇰🇷 Wonju, Kang-won-do, Korea, Republic of

National Cancer Center ( Site 3801); 🇰🇷 Goyang-si, Kyonggi-do, Korea, Republic of

The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3800); 🇰🇷 Suwon-si, Kyonggi-do, Korea, Republic of

Ajou University Hospital-Hematology-Oncology ( Site 3806); 🇰🇷 Suwon-si, Kyonggi-do, Korea, Republic of

Keimyung University Dongsan Hospital CRC room 1 ( Site 3807); 🇰🇷 Daegu, Taegu-Kwangyokshi, Korea, Republic of

Klinikum Bogenhausen-Klinik für Pneumologie und Onkologische Pneumologie ( Site 1406); 🇩🇪 München, Bayern, Germany

Bethanien Krankenhaus Moers ( Site 1400); 🇩🇪 Moers, Nordrhein-Westfalen, Germany

Universitätsklinikum Münster - Albert Schweitzer Campus-Medizinische Klinik A ( Site 1410); 🇩🇪 Münster, Nordrhein-Westfalen, Germany

ETZ Elisabeth-Department of Pulmonary Diseases ( Site 1902); 🇳🇱 Tilburg, Noord-Brabant, Netherlands

Isala, locatie Zwolle-Poli Longziekten ( Site 1903); 🇳🇱 Zwolle, Overijssel, Netherlands

Clinica Vallesur - AUNA ( Site 0854); 🇵🇪 Arequipa, Ariqipa, Peru

Detecta Clínica ( Site 0853); 🇵🇪 Surquillo, Muni Metro De Lima, Peru

IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 0851); 🇵🇪 Lima, Peru

INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0850); 🇵🇪 Lima, Peru

Hospital Cayetano Heredia-Oncology ( Site 0855); 🇵🇪 Lima, Peru

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003); 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland

Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 2016); 🇵🇱 Torun, Kujawsko-pomorskie, Poland

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 2015); 🇵🇱 Kraków, Malopolskie, Poland

Instytut Gruźlicy i Chorób Płuc w Warszawie-3rd Dep of Lung Diseases and Oncology ( Site 2011); 🇵🇱 Warszawa, Mazowieckie, Poland

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

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001); 🇵🇱 Przemysl, Podkarpackie, Poland

Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 2101); 🇵🇹 Lisbon, Lisboa, Portugal

Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 2103); 🇵🇹 Vila Nova de Gaia, Porto, Portugal

Hospital CUF - Tejo ( Site 2100); 🇵🇹 Lisboa, Portugal

Hospital Jerez de la Frontera-UGC Oncología ( Site 2333); 🇪🇸 Jerez de la Frontera, Cadiz, Spain

CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 2335); 🇪🇸 A Coruña, La Coruna, Spain

Universitätsmedizin Johannes Gutenberg Universität Mainz-3. Medizinische Klinik und Poliklinik ( Sit; 🇩🇪 Mainz, Rheinland-Pfalz, Germany

SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1403); 🇩🇪 Gera, Thuringen, Germany

Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1402; 🇩🇪 Berlin, Germany

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 18; 🇮🇹 Meldola, Emilia-Romagna, Italy

P.O. "S. Maria della Misericordia" Azienda Sanitaria Univers-Oncology Department ( Site 1803); 🇮🇹 Udine, Friuli-Venezia Giulia, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1800); 🇮🇹 Milan, Lombardia, Italy

Axis Heilsa S. de R.L. de C.V. ( Site 0719); 🇲🇽 Monterrey, Nuevo Leon, Mexico

Centro de Atención e Investigación Cardiovascular del Potosí ( Site 0713); 🇲🇽 San Luis Potosí, San Luis Potosi, Mexico

Clinica Integral Internacional de Oncología ( Site 0714); 🇲🇽 Puebla, Mexico

Amphia Ziekenhuis, locatie Breda Molengracht-long oncologie ( Site 1901); 🇳🇱 Breda, Noord-Brabant, Netherlands

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2331); 🇪🇸 Pozuelo de Alarcon, Madrid, Spain

H.R.U Malaga - Hospital General ( Site 2332); 🇪🇸 Málaga, Malaga, Spain

Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2336); 🇪🇸 Valencia, Valenciana, Comunitat, Spain

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 2337); 🇪🇸 Sevilla, Spain

Medipol Mega Universite Hastanesi-oncology ( Site 2508); 🇹🇷 Stanbul, Istanbul, Turkey

Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2503); 🇹🇷 Bornova, Izmir, Turkey

Hospital Universitari Vall d'Hebron-Oncology ( Site 2330); 🇪🇸 Barcelona, Spain

Chang Gung Memorial Hospital at Kaohsiung ( Site 3902); 🇨🇳 Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan

Chi Mei Hospital - Liouying Branch ( Site 3908); 🇨🇳 Tainan City, Tainan, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3904); 🇨🇳 Kaohsiung, Taiwan

Taichung Veterans General Hospital-Chest ( Site 3905); 🇨🇳 Taichung, Taiwan

National Cheng Kung University Hospital-Clinical Trial Center ( Site 3903); 🇨🇳 Tainan, Taiwan

National Taiwan University Hospital-Oncology ( Site 3906); 🇨🇳 Taipei, Taiwan

Chulalongkorn University-Medicine ( Site 4003); 🇹🇭 Bangkok, Krung Thep Maha Nakhon, Thailand

Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2507); 🇹🇷 Adana, Turkey

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-oncology ( Site 2506); 🇹🇷 Ankara, Turkey

Hacettepe Universite Hastaneleri-oncology hospital ( Site 2501); 🇹🇷 Ankara, Turkey

Memorial Ankara Hastanesi-Medical Oncology ( Site 2505); 🇹🇷 Ankara, Turkey

National Taiwan University Cancer Center (NTUCC) ( Site 3907); 🇨🇳 Taipei City, Taipei, Taiwan

National Taiwan University Hospital - Hsinchu branch ( Site 3901); 🇨🇳 Hsinchu, Taiwan

Faculty of Medicine Siriraj Hospital ( Site 4000); 🇹🇭 Bangkok, Krung Thep Maha Nakhon, Thailand

Maharaj Nakorn Chiang Mai Hospital-Chiang Mai Clinical Trial Unit (CM-CTU) ( Site 4001); 🇹🇭 Chiang Mai, Thailand

Erciyes University ( Site 2511); 🇹🇷 Talas, Kayseri, Turkey

Ankara Bilkent Şehir Hastanesi ( Site 2500); 🇹🇷 Ankara, Turkey

Pamukkale University Medical Faculty, Fahri Goksin Oncology Centre-Oncolgyy-Hematology ( Site 2510); 🇹🇷 Denizli, Turkey

Queen Alexandra Hospital-Oncology Department ( Site 2603); 🇬🇧 Portsmouth, Hampshire, United Kingdom

Kent and Canterbury Hospital-Oncology Research ( Site 2606); 🇬🇧 Canterbury, Kent, United Kingdom

Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 2605); 🇬🇧 London, London, City Of, United Kingdom

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

Ondokuz Mayıs Universitesi ( Site 2509); 🇹🇷 Samsun, Turkey

Royal Free Hospital ( Site 2601); 🇬🇧 London, England, United Kingdom

James Cook University Hospital ( Site 2604); 🇬🇧 Central Middlesbrough, Middlesbrough, United Kingdom

K Hospital - National Cancer Hospital ( Site 4174); 🇻🇳 Hanoi, Ha Noi, Vietnam

National Lung Hospital-Oncology Department ( Site 4175); 🇻🇳 Hanoi, Ha Noi, Vietnam

Ho Chi Minh City Oncology Hospital - Tan Phu Ward ( Site 4173); 🇻🇳 Ho Chi Minh, Vietnam