Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]

Phase 3

Recruiting

• Conditions: Non-small Cell Lung Cancer; NSCLC
• Interventions: Biological: Pembrolizumab; Biological: sac-TMT; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel

• Registration Number: NCT06422143
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).

Detailed Description

All participants undergo an initial induction phase of four cycles, each cycle consisting of pembrolizumab q3w + carboplatin q3w + paclitaxel q3w or nabpaclitaxel weekly. Participants are then randomly assigned to pembrolizumab maintenance vs. pembrolizumab + sac-TMT maintenance.

Study Timeline

• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-05-15
• Study First Posted: 2024-05-20
• Study Start: 2024-06-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16
• Primary Completion: 2029-01-12
• Study Completion: 2031-02-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 851

Inclusion Criteria

• Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) [Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8]
• Measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site investigator/radiology
• Has life expectancy ≥3 months
• Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 assessed within 7 days prior to allocation
• Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
• Participants who are hepatitis B surface antigen (HBsAg)-positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation
• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
• Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤ Grade 1 or baseline (participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible)
• Has adequate organ function
• For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by BICR using RECIST 1.1 after completion of study-specified Induction with an evaluable scan at Week 12
• For Maintenance only (prior to randomization): has ECOG PS of 0 or 1 as assessed at the Prerandomization Visit
• For Maintenance only (prior to randomization): all AEs (with the exception of alopecia, Grade 2 fatigue, and Grade ≤2 endocrine-related AEs requiring treatment or hormone replacement) have recovered

Exclusion Criteria

• Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
• History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
• Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, 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 QTcF interval to >480 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention
• HIV-infected participants who have been newly diagnosed or with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• Received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC
• Received prior therapy with an anti-programmed cell death-1 (PD-1), anti-PD-Ligand 1 (PD-L1), or anti-PD-Lignad 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic Tlymphocyte-associated protein 4, OX-40, CD137) [Note: Prior treatment with chemotherapy and/or radiation as a part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.]
• Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antidrug conjugate (ADC)
• Received radiation therapy to the lung that is >30 Gray 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
• Participants who have not adequately recovered from major surgery or have ongoing surgical complications
• Received prior treatment with a topoisomerase I inhibitor-containing ADC
• Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of the study (the required washout period before starting sac-TMT is 2 weeks)
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Has known central nervous system (CNS) metastases/carcinomatous meningitis
• Severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients or to another biologic therapy
• Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapy [eg, thyroxine, insulin, or physiologic corticosteroid] is allowed)
• History of (noninfectious)pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Active infection requiring systemic therapy
• History of allogeneic tissue/solid organ transplant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maintenance Arm A: Pembrolizumab + sac-TMT	Pembrolizumab	During the Induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin area under the curve (AUC) 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. During the Maintenance phase, participants receive sac-TMT 4 mg/kg infusion every 2 weeks (q2w) until discontinuation criteria is met for sac-TMT; and pembrolizumab 400 mg every 6 weeks (q6w) for 96 weeks.
Maintenance Arm A: Pembrolizumab + sac-TMT	Carboplatin	During the Induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin area under the curve (AUC) 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. During the Maintenance phase, participants receive sac-TMT 4 mg/kg infusion every 2 weeks (q2w) until discontinuation criteria is met for sac-TMT; and pembrolizumab 400 mg every 6 weeks (q6w) for 96 weeks.
Maintenance Arm A: Pembrolizumab + sac-TMT	Paclitaxel	During the Induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin area under the curve (AUC) 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. During the Maintenance phase, participants receive sac-TMT 4 mg/kg infusion every 2 weeks (q2w) until discontinuation criteria is met for sac-TMT; and pembrolizumab 400 mg every 6 weeks (q6w) for 96 weeks.
Maintenance Arm A: Pembrolizumab + sac-TMT	Nab-paclitaxel	During the Induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin area under the curve (AUC) 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. During the Maintenance phase, participants receive sac-TMT 4 mg/kg infusion every 2 weeks (q2w) until discontinuation criteria is met for sac-TMT; and pembrolizumab 400 mg every 6 weeks (q6w) for 96 weeks.
Maintenance Arm B: Pembrolizumab Monotherapy	Pembrolizumab	During the induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin AUC 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. During the Maintenance phase, participants receive pembrolizumab 400 mg q6w for 96 weeks.
Maintenance Arm B: Pembrolizumab Monotherapy	Carboplatin	During the induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin AUC 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. During the Maintenance phase, participants receive pembrolizumab 400 mg q6w for 96 weeks.
Maintenance Arm B: Pembrolizumab Monotherapy	Paclitaxel	During the induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin AUC 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. During the Maintenance phase, participants receive pembrolizumab 400 mg q6w for 96 weeks.
Maintenance Arm B: Pembrolizumab Monotherapy	Nab-paclitaxel	During the induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin AUC 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. During the Maintenance phase, participants receive pembrolizumab 400 mg q6w for 96 weeks.
Maintenance Arm A: Pembrolizumab + sac-TMT	sac-TMT	During the Induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin area under the curve (AUC) 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. During the Maintenance phase, participants receive sac-TMT 4 mg/kg infusion every 2 weeks (q2w) until discontinuation criteria is met for sac-TMT; and pembrolizumab 400 mg every 6 weeks (q6w) for 96 weeks.

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to ~50 months	OS is the time from randomization to death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Up to ~79 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).
Number of Participants With ≥1 Adverse Event (AE)	Up to ~79 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.
Number of Participants Discontinuing from Study Therapy Due to AE(s)	Up to ~79 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.
Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Global health status/Quality of Life (QoL) Score (EORTC QLQ-C30 Items 29 and 30)	Baseline and up to ~79 months	European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is a 30-item scale to assess the overall quality of life in cancer patients. The global health status and QoL scores are based on participant responses to items 29 ("How would you rate your overall health during past week?") and 30 ("How would you rate your overall quality of life during the week?") that are scored on a 7-point scale (1 = "Very poor" to 7 = "Excellent"). Higher scores indicate better overall health status.
Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Dyspnea (EORTC QLQ-C30 Item 8)	Baseline and up to ~79 months	EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The dyspnea score is based on participant responses to item 8 ("Were you short of breath?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse dyspnea symptoms.
Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Cough (EORTC QLQ-LC13 Item 31)	Baseline and up to ~79 months	EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. The cough score is based on participant responses to item 31 ("How much did you cough?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse cough.
Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Chest Pain (EORTC QLQ-LC13 Item 40)	Baseline and up to ~79 months	EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. The chest pain score is based on participant responses to item 40 e (1 = "Not at All" to 4 = "Very Much").
Time to First Deterioration (TTD) in Global Health Status/QoL Scores (EORTC QLQ-C30 Items 29 and 30)	Up to ~79 months	EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life in cancer patients. TTD in global health status and QoL scores are based on participant responses to items 29 ("How would you rate your overall health during past week?") and 30 ("How would you rate your overall quality of life during the week?") that are scored on a 7-point scale (1 = "Very poor" to 7 = "Excellent"). Higher scores indicate better overall health status.
TTD in Dyspnea Score (EORTC QLQ-C30 Item 8)	Up to ~79 months	EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. TTD in dyspnea score is based on participant responses to item 8 ("Were you short of breath?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse dyspnea symptoms.
TTD in Cough Score (EORTC QLQ-LC13 Item 31)	Up to ~79 months	EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. TTD in cough score is based on participant responses to item 31 ("How much did you cough?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse cough.
TTD in Chest Pain Score (EORTC QLQ-LC13 Item 40)	Up to ~79 months	EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. TTD in chest pain score is based on participant responses to item 40 ("Have you had pain in your chest?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse chest pain.

Trial Locations

Locations (176)

Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0122); 🇺🇸 Burbank, California, United States

Exempla Lutheran Medical Center ( Site 0119); 🇺🇸 Golden, Colorado, United States

Mid Florida Hematology and Oncology Center ( Site 0109); 🇺🇸 Orange City, Florida, United States

Centricity Research Columbus Cancer Center ( Site 0111); 🇺🇸 Columbus, Georgia, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0001); 🇺🇸 Marietta, Georgia, United States

University of Chicago Medical Center ( Site 0145); 🇺🇸 Chicago, Illinois, United States

Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0146); 🇺🇸 Minneapolis, Minnesota, United States

New Mexico Oncology Hematology Consultants Ltd. ( Site 0123); 🇺🇸 Albuquerque, New Mexico, United States

Thomas Jefferson University - Clinical Research Institute ( Site 0147); 🇺🇸 Philadelphia, Pennsylvania, United States

Oncology Consultants P.A. ( Site 0124); 🇺🇸 Houston, Texas, United States

Mays Cancer Center ( Site 0132); 🇺🇸 San Antonio, Texas, United States

Instituto Alexander Fleming ( Site 0203); 🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0200); 🇦🇷 Mar del Plata, Buenos Aires, Argentina

Instituto Médico Río Cuarto ( Site 0204); 🇦🇷 Rio Cuarto., Cordoba, Argentina

Fundacion Intecnus ( Site 0205); 🇦🇷 San Carlos de Bariloche, Rio Negro, Argentina

Sanatorio Parque ( Site 0201); 🇦🇷 Rosario, Santa Fe, Argentina

Hospital Aleman-Oncology ( Site 0202); 🇦🇷 Buenos Aires, Argentina

Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0720); 🇦🇹 Linz, Oberosterreich, Austria

Klinik Hietzing ( Site 0740); 🇦🇹 Wien, Austria

Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 0730); 🇦🇹 Wien, Austria

Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0710); 🇦🇹 Wien, Austria

Hospital de Câncer de Recife ( Site 0312); 🇧🇷 Recife, Pernambuco, Brazil

Oncoclínica Oncologistas Associados ( Site 0309); 🇧🇷 Terezina, Piaui, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0311); 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Hospital Nossa Senhora da Conceição ( Site 0300); 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Instituto de Oncologia Saint Gallen ( Site 0304); 🇧🇷 Santa Cruz do Sul, Rio Grande Do Sul, Brazil

Hospital de Base de São José do Rio Preto ( Site 0310); 🇧🇷 São José do Rio Preto, Sao Paulo, Brazil

Hospital Paulistano ( Site 0307); 🇧🇷 Sao Paulo, Brazil

Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0100); 🇨🇦 Kingston, Ontario, Canada

Grand River Hospital ( Site 0153); 🇨🇦 Kitchener, Ontario, Canada

St. Marys Hospital Center ( Site 0105); 🇨🇦 Montreal, Quebec, Canada

McGill University Health Centre ( Site 0103); 🇨🇦 Montréal, Quebec, Canada

Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0106); 🇨🇦 Trois-Rivières, Quebec, Canada

Centro de Investigación del Maule ( Site 0419); 🇨🇱 Talca, Maule, Chile

FALP ( Site 0409); 🇨🇱 Santiago, Region M. De Santiago, Chile

Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0402); 🇨🇱 Santiago, Region M. De Santiago, Chile

Bradfordhill-Clinical Area ( Site 0407); 🇨🇱 Santiago, Region M. De Santiago, Chile

ONCOCENTRO APYS-ACEREY ( Site 0400); 🇨🇱 Viña del Mar, Valparaiso, Chile

Bradford Hill Norte ( Site 0420); 🇨🇱 Antofagasta, Chile

Beijing Cancer Hospital ( Site 2411); 🇨🇳 Beijing, Beijing, China

Beijing Cancer hospital-intrathoratic deparmtment II ( Site 2410); 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital ( Site 2412); 🇨🇳 Beijing, Beijing, China

Army Medical Center of People's Liberation Army-respiratory ( Site 2426); 🇨🇳 Chongqing, Chongqing, China

Fujian Provincial Cancer Hospital ( Site 2419); 🇨🇳 Fuzhou, Fujian, China

The First Affiliated hospital of Xiamen University-oncology ( Site 2420); 🇨🇳 Xiamen, Fujian, China

The First Affiliated Hospital of Guangzhou Medical University ( Site 2417); 🇨🇳 Guangzhou, Guangdong, China

Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 2416); 🇨🇳 Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital-oncology of department ( Site 2415); 🇨🇳 Harbin, Heilongjiang, China

Henan Cancer Hospital-Pneumology department ( Site 2423); 🇨🇳 Zhengzhou, Henan, China

Tongji Hospital Tongji Medical,Science & Technology ( Site 2424); 🇨🇳 Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University-Oncology ( Site 2418); 🇨🇳 Changsha, Hunan, China

First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 2402); 🇨🇳 Huai'an, Jiangsu, China

Northern Jiangsu People's Hospital-General Surgery Department ( Site 2403); 🇨🇳 Yangzhou, Jiangsu, China

The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2405); 🇨🇳 Nanchang, Jiangxi, China

The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 2404); 🇨🇳 Nanchang, Jiangxi, China

Jilin Province Tumor Hospital-GCP office ( Site 2413); 🇨🇳 Changchun, Jilin, China

The First Hospital of Jilin University-Oncology ( Site 2414); 🇨🇳 Changchun, Jilin, China

Shanghai East Hospital ( Site 2428); 🇨🇳 Shanghai, Shanghai, China

Shanghai Pulmonary Hospital ( Site 2427); 🇨🇳 Shanghai, Shanghai, China

West China Hospital, Sichuan University ( Site 2422); 🇨🇳 Cheng Du, Sichuan, China

Sichuan Cancer hospital. ( Site 2421); 🇨🇳 Chengdu, Sichuan, China

The Affiliated Cancer Hospital of Xinjiang Medical University ( Site 2425); 🇨🇳 Urumqi, Xinjiang, China

The first Affiliated Hospital, Zhejiang University School of Medicine-Respiratory Department ( Site 2406); 🇨🇳 Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Medical Oncology ( Site 2407); 🇨🇳 Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital-Breast Oncology ( Site 2408); 🇨🇳 Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 2409); 🇨🇳 Wenzhou, Zhejiang, China

Centro Cancerológico del Caribe (CECAC) ( Site 0509); 🇨🇴 Barranquilla, Atlantico, Colombia

Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0501); 🇨🇴 Valledupar, Cesar, Colombia

FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0500); 🇨🇴 Bogota, Distrito Capital De Bogota, Colombia

Oncologos del Occidente ( Site 0504); 🇨🇴 Pereira., Risaralda, Colombia

Fundación Valle del Lili-Oncology CIC ( Site 0505); 🇨🇴 Cali, Valle Del Cauca, Colombia

Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0800); 🇨🇿 Brno, Brno-mesto, Czechia

Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni oddeleni ( Site 0803); 🇨🇿 Ostrava-Vitkovice, Ostrava Mesto, Czechia

Clinique Clairval ( Site 0904); 🇫🇷 Marseille, Bouches-du-Rhone, France

Hôpital Robert Schuman ( Site 0907); 🇫🇷 Vantoux, Lorraine, France

Institut de Cancérologie de l'Ouest ( Site 0908); 🇫🇷 ANGERS cedex 02, Maine-et-Loire, France

Sainte Catherine Institut du Cancer Avignon Provence ( Site 0902); 🇫🇷 Avignon, Vaucluse, France

CHD Vendee ( Site 0901); 🇫🇷 La Roche-sur-Yon, Vendee, France

Hôpital Saint-Louis ( Site 0906); 🇫🇷 Paris, France

GEFOS Gesellschaft f. onkologische Studien ( Site 1005); 🇩🇪 Dortmund, Nordrhein-Westfalen, Germany

SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1006); 🇩🇪 Gera, Thuringen, Germany

Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1003); 🇩🇪 Berlin, Germany

Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 1100); 🇭🇺 Kecskemét, Bacs-Kiskun, Hungary

Petz Aladar Egyetemi Oktato Korhaz ( Site 1101); 🇭🇺 Gyor, Gyor-Moson-Sopron, Hungary

Reformatus Pulmonologiai Centrum ( Site 1102); 🇭🇺 Torokbalint, Pest, Hungary

Zala Megyei Szent Rafael Kórház ( Site 1110); 🇭🇺 Zalaegerszeg, Zala, Hungary

Országos Korányi Pulmonológiai Intézet ( Site 1104); 🇭🇺 Budapest, Hungary

St. James's Hospital ( Site 1200); 🇮🇪 Dublin, Ireland

Rambam Health Care Campus-Oncology Division ( Site 1302); 🇮🇱 Haifa, Israel

Shaare Zedek Medical Center ( Site 1300); 🇮🇱 Jerusalem, Israel

Rabin Medical Center ( Site 1303); 🇮🇱 Petah Tikva, Israel

Sheba Medical Center ( Site 1301); 🇮🇱 Ramat Gan, Israel

Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1409); 🇮🇹 Roma, Lazio, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1404); 🇮🇹 Milan, Lombardia, Italy

Fondazione IRCCS San Gerardo dei Tintori-Oncologia ( Site 1412); 🇮🇹 Monza, Lombardia, Italy

Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1408); 🇮🇹 Rozzano, Milano, Italy

Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1402); 🇮🇹 Rome, Roma, Italy

Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 1414); 🇮🇹 Brescia, Italy

Ospedale San Martino ( Site 1407); 🇮🇹 Genova, Italy

Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 1410); 🇮🇹 Pavia, Italy

Ospedale di Circolo e Fondazione Macchi Varese-Oncology ( Site 1413); 🇮🇹 Varese, Italy

Aichi Cancer Center ( Site 2502); 🇯🇵 Nagoya, Aichi, Japan

Nagoya University Hospital ( Site 2519); 🇯🇵 Nagoya, Aichi, Japan

Fujita Health University Hospital ( Site 2515); 🇯🇵 Toyoake, Aichi, Japan

Hirosaki University Hospital ( Site 2514); 🇯🇵 Hirosaki, Aomori, Japan

Ehime University Hospital ( Site 2511); 🇯🇵 Toon, Ehime, Japan

Gunma Prefectural Cancer Center ( Site 2510); 🇯🇵 Ota, Gunma, Japan

Takarazuka City Hospital ( Site 2508); 🇯🇵 Takarazuka, Hyogo, Japan

Kanazawa University Hospital ( Site 2513); 🇯🇵 Kanazawa, Ishikawa, Japan

Kanagawa Cardiovascular and Respiratory Center ( Site 2518); 🇯🇵 Yokohama, Kanagawa, Japan

Kanagawa Cancer Center ( Site 2504); 🇯🇵 Yokohama, Kanagawa, Japan

Matsusaka Municipal Hospital ( Site 2522); 🇯🇵 Matsusaka, Mie, Japan

Sendai Kousei Hospital ( Site 2507); 🇯🇵 Sendai, Miyagi, Japan

Kansai Medical University Hospital ( Site 2503); 🇯🇵 Hirakata, Osaka, Japan

Saitama Prefectural Cancer Center ( Site 2512); 🇯🇵 Kitaadachi-gun, Saitama, Japan

Cancer Institute Hospital of JFCR ( Site 2500); 🇯🇵 Koto, Tokyo, Japan

Toho University Omori Medical Center ( Site 2520); 🇯🇵 Ota, Tokyo, Japan

National Center for Global Health and Medicine ( Site 2516); 🇯🇵 Shinjuku, Tokyo, Japan

Chiba University Hospital ( Site 2517); 🇯🇵 Chiba, Japan

National Hospital Organization Kyushu Medical Center ( Site 2509); 🇯🇵 Fukuoka, Japan

Niigata Cancer Center Hospital ( Site 2505); 🇯🇵 Niigata, Japan

Osaka International Cancer Institute ( Site 2506); 🇯🇵 Osaka, Japan

The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 2106); 🇰🇷 Bupyeong-gu, Incheon, Korea, Republic of

Pusan National University Yangsan Hospital ( Site 2104); 🇰🇷 Yangsan-si, Kyongsangnam-do, Korea, Republic of

Pusan National University Hospital ( Site 2100); 🇰🇷 Busan, Pusan-Kwangyokshi, Korea, Republic of

Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2102); 🇰🇷 Deagu, Taegu-Kwangyokshi, Korea, Republic of

Chungnam national university hospital-Department of Internal Medicine ( Site 2107); 🇰🇷 Daejeon, Taejon-Kwangyokshi, Korea, Republic of

Kyung Hee University Hospital ( Site 2101); 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center ( Site 2105); 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital-Internal Medicine ( Site 2103); 🇰🇷 Seoul, Korea, Republic of

Clínicas AUNA Sede Chiclayo ( Site 0604); 🇵🇪 Chiclayo, Lambayeque, Peru

Oncosalud-Clinical Research ( Site 0600); 🇵🇪 Lima, Peru

Hospital Militar Central Coronel Luis Arias Schereiber ( Site 0602); 🇵🇪 Lima, Peru

Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 1510); 🇵🇱 Poznań, Dolnoslaskie, Poland

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1503); 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland

Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 1513); 🇵🇱 Grudziadz, Kujawsko-pomorskie, Poland

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1515); 🇵🇱 Kraków, Malopolskie, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 1500); 🇵🇱 Warszawa, Mazowieckie, Poland

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1501); 🇵🇱 Przemysl, Podkarpackie, Poland

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1517); 🇵🇱 Koszalin, Zachodniopomorskie, Poland

Centrul Medical Medicover Victoria ( Site 2000); 🇷🇴 Bucharest, Bucuresti, Romania

Cardiomed SRL Cluj-Napoca ( Site 2002); 🇷🇴 Cluj-Napoca, Cluj, Romania

SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2001); 🇷🇴 Florești, Cluj, Romania

Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2004); 🇷🇴 Craiova, Dolj, Romania

Cabinet Medical Oncomed ( Site 2005); 🇷🇴 Timisoara, Timis, Romania

SC ONCO CARD SRL ( Site 2007); 🇷🇴 Brasov, Romania

Clinica Polisano ( Site 2008); 🇷🇴 Sibiu, Romania

CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 1703); 🇪🇸 Santiago de Compostela, Galicia, Spain

Hospital Insular de Gran Canaria-Oncology ( Site 1701); 🇪🇸 Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Quirón Málaga ( Site 1704); 🇪🇸 Málaga, Malaga, Spain

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1700); 🇪🇸 Barcelona, Spain

Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 1702); 🇪🇸 Madrid, Spain

Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 1705); 🇪🇸 Sevilla, Spain

Chang Gung Memorial Hospital at Kaohsiung ( Site 2207); 🇨🇳 Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan

National Taiwan University Cancer Center (NTUCC) ( Site 2209); 🇨🇳 Taipei City, Taipei, Taiwan

Taoyuan General Hospital ( Site 2203); 🇨🇳 Taoyuan City, Taoyuan, Taiwan

Taichung Veterans General Hospital ( Site 2204); 🇨🇳 Taichung, Taiwan

National Cheng Kung University Hospital ( Site 2205); 🇨🇳 Tainan, Taiwan

National Taiwan University Hospital-Oncology ( Site 2208); 🇨🇳 Taipei, Taiwan

Mackay Memorial Hospital-Chest Medicine ( Site 2201); 🇨🇳 Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch-Clinic of Chest Medicine ( Site 2202); 🇨🇳 Taoyuan, Taiwan

Prapokklao Hospital ( Site 2306); 🇹🇭 Mueang, Chanthaburi, Thailand

Faculty of Medicine - Khon Kaen University ( Site 2305); 🇹🇭 Muang, Khon Kaen, Thailand

Faculty of Medicine Siriraj Hospital ( Site 2301); 🇹🇭 Bangkok, Krung Thep Maha Nakhon, Thailand

Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 2300); 🇹🇭 Dusit, Krung Thep Maha Nakhon, Thailand

Lampang Cancer Hospital ( Site 2304); 🇹🇭 Mueang Lampang, Lampang, Thailand

Songklanagarind hospital ( Site 2303); 🇹🇭 HatYai, Songkhla, Thailand

Maharaj Nakorn Chiang Mai Hospital ( Site 2302); 🇹🇭 Chiang Mai, Thailand

Medipol Mega Universite Hastanesi-oncology ( Site 1811); 🇹🇷 Stanbul, Istanbul, Turkey

Hacettepe Universite Hastaneleri-oncology hospital ( Site 1801); 🇹🇷 Ankara, Turkey

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1800); 🇹🇷 Ankara, Turkey

Memorial Kayseri Hastanesi ( Site 1805); 🇹🇷 Kayseri, Turkey

Mersin Sehir Eğitim ve Araştırma Hastanesi-Oncology ( Site 1808); 🇹🇷 Mersin, Turkey

Samsun Medical Park Hastanesi-medical oncology ( Site 1806); 🇹🇷 Samsun, Turkey

St Bartholomew's Hospital ( Site 1901); 🇬🇧 London, London, City Of, United Kingdom

City Hospital, Nottingham University Hospitals NHS Trust-NCCTT ( Site 1911); 🇬🇧 Nottingham, Nottinghamshire, United Kingdom