A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)

Phase 3

Recruiting

• Conditions: Non Small Cell Lung Cancer
• Interventions: Biological: Sacituzumab tirumotecan; Biological: Pembrolizumab; Drug: Cisplatin; Drug: Pemetrexed; Drug: Gemcitabine; Drug: Carboplatin; Drug: Paclitaxel

• Registration Number: NCT06312137
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-08
• Study First Posted: 2024-03-15
• Study Start: 2024-04-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-27
• Primary Completion: 2034-02-21
• Study Completion: 2034-10-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 780

Inclusion Criteria

• Has histological or cytological confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement [N2]) per AJCC eighth edition guidelines.
• Has confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy.
• Is able to undergo surgery based on opinion of investigator after consultation with surgeon.
• Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy.
• Applies to screening for the adjuvant period only, before randomization: Has not achieved pathological complete response (pCR) at surgery by local review of pathology.
• Applies to screening for the adjuvant period only, before randomization: Tumor tissue sample from surgical resection has been provided for determination of programmed cell death ligand 1 (PD-L1) and trophoblast cell surface antigen 2 (TROP2) status by central vendor before randomization into the adjuvant period.
• Applies to screening for the adjuvant period only, before randomization: Confirmed to be disease-free based on re-baseline radiological assessment as documented by contrast enhanced chest/abdomen/pelvis computed tomography (CT) (or magnetic resonance imaging (MRI)) within 28 days before randomization.
• Participants who have 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.
• 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 at screening.
• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at least 4 weeks before the start of study intervention.

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Exclusion Criteria

• Has one of the following tumor locations/types:

  • NSCLC involving the superior sulcus
  • Large cell neuro-endocrine cancer (LCNEC)
  • Sarcomatoid tumor
  • Diagnosis of SCLC or, for mixed tumors, presence of small cell elements
  • Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements

• Has Grade ≥2 peripheral neuropathy.

• Has 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 history of inflammatory bowel disease.

• 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 QT corrected for heart rate by Fridericia's cube root formula (QTcF) interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.

• Has received prior neoadjuvant therapy for their current NSCLC diagnosis.

• Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention.

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

• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.

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

• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.

• Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.

• Has an active autoimmune disease that has required systemic treatment in the past 2 years.

• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.

• Has an active infection requiring systemic therapy.

• Is an HIV-infected participant with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.

• Has a concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection.

• Has a severe hypersensitivity (Grade ≥3) to sacituzumab tirumotecan, any of its excipients and/or to another biologic therapy.

• Has a history of allogeneic tissue/solid organ transplant.

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pembrolizumab + Sacituzumab tirumotecan	Sacituzumab tirumotecan	Participants will receive pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W) for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by sacituzumab tirumotecan 4 mg/kg IV infusion every 2 weeks (Q2W) for up to 20 doses (\~40 weeks) with pembrolizumab monotherapy 200 mg IV infusion every 6 weeks (Q6W) for up to 7 cycles (\~42 weeks).
Pembrolizumab	Pembrolizumab	Participants will receive pembrolizumab 200 mg intravenous (IV) infusion Q3W for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by pembrolizumab monotherapy 200 mg IV infusion Q6W for up to 7 cycles (\~42 weeks).
Pembrolizumab	Cisplatin	Participants will receive pembrolizumab 200 mg intravenous (IV) infusion Q3W for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by pembrolizumab monotherapy 200 mg IV infusion Q6W for up to 7 cycles (\~42 weeks).
Pembrolizumab	Pemetrexed	Participants will receive pembrolizumab 200 mg intravenous (IV) infusion Q3W for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by pembrolizumab monotherapy 200 mg IV infusion Q6W for up to 7 cycles (\~42 weeks).
Pembrolizumab + Sacituzumab tirumotecan	Pembrolizumab	Participants will receive pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W) for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by sacituzumab tirumotecan 4 mg/kg IV infusion every 2 weeks (Q2W) for up to 20 doses (\~40 weeks) with pembrolizumab monotherapy 200 mg IV infusion every 6 weeks (Q6W) for up to 7 cycles (\~42 weeks).
Pembrolizumab	Gemcitabine	Participants will receive pembrolizumab 200 mg intravenous (IV) infusion Q3W for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by pembrolizumab monotherapy 200 mg IV infusion Q6W for up to 7 cycles (\~42 weeks).
Pembrolizumab	Carboplatin	Participants will receive pembrolizumab 200 mg intravenous (IV) infusion Q3W for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by pembrolizumab monotherapy 200 mg IV infusion Q6W for up to 7 cycles (\~42 weeks).
Pembrolizumab	Paclitaxel	Participants will receive pembrolizumab 200 mg intravenous (IV) infusion Q3W for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by pembrolizumab monotherapy 200 mg IV infusion Q6W for up to 7 cycles (\~42 weeks).

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR)	Up to ~ 93 months	DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to ~ 118 months	OS is defined as the time from randomization to death due to any cause.
Number of Participants Who Experience at least One Adverse Event (AE)	Up to ~ 118 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Distant metastasis-free survival (DMFS) as assessed by investigator	Up to ~ 118 months	DMFS is defined as the time from randomization to the first documented distant metastasis or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes.
Lung Cancer Specific Survival (LCSS)	Up to ~ 118 months	LCSS is defined as the time from randomization to the date of death due to lung cancer.
Disease-Free Survival (DFS) as assessed by investigator	Up to ~ 118 months	DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.
Number of Participants Who Discontinue Study Intervention Due to AEs	Up to ~ 118 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be presented.
Change from Baseline in Global Health Status/Quality of Life (QoL) score (Quality of Life Questionnaire (QLQ)-C30 Items 29 and 30)	Baseline and up to ~118 months	The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) is a psychometrically and clinically validated instrument appropriate for assessing the health-related quality of life (HRQoL) of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for the global health status or QoL a higher value indicates a better level of function.
Change from Baseline in Physical Functioning Score (QLQ-C30 Items 1 to 5)	Baseline and up to ~118 months	The EORTC-QLQ is a psychometrically and clinically validated instrument appropriate for assessing the HRQoL of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for all physical functional scales, a higher value indicates a better level of function.
Change from Baseline in Role Functioning Score (QLQ-C30 Items 6 and 7)	Baseline and up to ~118 months	The EORTC-QLQ is a psychometrically and clinically validated instrument appropriate for assessing the HRQoL of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for all role functional scales, a higher value indicates a better level of function.
Change from Baseline in Dyspnea scores (QLQ-C30 Item 8)	Baseline and up to ~118 months	The EORTC-QLQ is a psychometrically and clinically validated instrument appropriate for assessing the HRQoL of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for symptom scales such as dyspnea, a higher value indicates increased severity of symptoms.
Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52)	Baseline and up to ~118 months	The lung cancer module of the EORTC, QLQ-LC24 is a revised and updated version of the Lung Cancer Module QLQ-LC13 and is a supplementary lung cancer specific module to be used along with EORTC QLQ C30. The QLQ-LC24 incorporates 4 multi-item scales to assess coughing, shortness of breath, hair problems, and fear of progression, for symptom scales as for cough, a higher value indicates increased severity of symptoms.
Change from Baseline in Chest pain scores (QLQ-LC24 Item 40)	Baseline and up to ~118 months	The lung cancer module of the EORTC, QLQ-LC24 is a revised and updated version of the Lung Cancer Module QLQ-LC13 and is a supplementary lung cancer specific module to be used along with EORTC QLQ C30. The QLQ-LC24 incorporates 4 multi-item scales to assess coughing, shortness of breath, hair problems, and fear of progression, for symptom scales as for chest pain, a higher value indicates increased severity of symptoms.

Trial Locations

Locations (145)

The Angeles Clinic and Research Institute ( Site 0040); 🇺🇸 Los Angeles, California, United States

The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate ( Site 0079); 🇺🇸 Los Angeles, California, United States

Medical University of South Carolina-Hollings Cancer Center ( Site 0045); 🇺🇸 Charleston, South Carolina, United States

Medizinische Universitaet Innsbruck-Department for Internal Medicine V ( Site 1403); 🇦🇹 Innsbruck, Tirol, Austria

VITAZ ( Site 1500); 🇧🇪 Sint-Niklaas, Oost-Vlaanderen, Belgium

Henan Cancer Hospital-henan cancer hospital ( Site 1316); 🇨🇳 Zhengzhou, Henan, China

Shandong Cancer Hospital ( Site 1321); 🇨🇳 Jinan, Shandong, China

Zhongshan Hospital Fudan University ( Site 1325); 🇨🇳 Shangai, Shanghai, China

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 23; 🇮🇹 Meldola, Emilia-Romagna, Italy

Fondazione IRCCS San Gerardo dei Tintori-Oncologia ( Site 2301); 🇮🇹 Monza, Lombardia, Italy

Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 2307); 🇮🇹 Firenze, Toscana, Italy

Ospedale San Martino ( Site 2313); 🇮🇹 Genova, Italy

Amphia Ziekenhuis, locatie Breda Molengracht-long oncologie ( Site 3453); 🇳🇱 Breda, Noord-Brabant, Netherlands

St. Antonius Ziekenhuis, locatie Utrecht-Pulmonary disease ( Site 3455); 🇳🇱 Utrecht, Netherlands

Instituto Neuro Cardiovascular de las Americas ( Site 0607); 🇵🇪 Lima, Peru

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

Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz; 🇵🇱 Poznan, Wielkopolskie, Poland

Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2901); 🇪🇸 L Hospitalet, Barcelona, Spain

CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2905); 🇪🇸 Santiago de Compostela, La Coruna, Spain

HFR Fribourg - Hôpital Cantonal ( Site 3004); 🇨🇭 Fribourg, Switzerland

Highlands Oncology Group-Research Department ( Site 0062); 🇺🇸 Springdale, Arkansas, United States

Mount Sinai Cancer Center ( Site 0038); 🇺🇸 Miami Beach, Florida, United States

Mid Florida Hematology and Oncology Center ( Site 0018); 🇺🇸 Orange City, Florida, United States

Centricity Research Columbus Cancer Center ( Site 0005); 🇺🇸 Columbus, Georgia, United States

Archbold Cancer Center ( Site 0071); 🇺🇸 Thomasville, Georgia, United States

Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0017); 🇺🇸 Elmhurst, Illinois, United States

Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0078); 🇺🇸 Naperville, Illinois, United States

Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0027); 🇺🇸 Minneapolis, Minnesota, United States

Mercy Research - David C. Pratt Cancer Center ( Site 0006); 🇺🇸 Saint Louis, Missouri, United States

Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0037); 🇺🇸 Reno, Nevada, United States

Stony Brook University-Cancer Center ( Site 0054); 🇺🇸 Stony Brook, New York, United States

Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0068); 🇺🇸 Lancaster, Pennsylvania, United States

Millennium Research & Clinical Development ( Site 0039); 🇺🇸 Houston, Texas, United States

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0213); 🇦🇷 Caba, Buenos Aires, Argentina

Hospital Británico de Buenos Aires-Oncology ( Site 0207); 🇦🇷 Ciudad autónoma de Buenos Aires, Buenos Aires, Argentina

Sanatorio Británico-Clinical Oncology Department ( Site 0206); 🇦🇷 Rosario, Santa Fe, Argentina

Sanatorio Parque ( Site 0205); 🇦🇷 Rosario, Santa Fe, Argentina

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

Hospital Privado Universitario de Córdoba-Hematology and Oncology ( Site 0204); 🇦🇷 Cordoba, Argentina

Westmead Hospital-Department of Medical Oncology ( Site 0701); 🇦🇺 Westmead, New South Wales, Australia

The Prince Charles Hospital ( Site 0700); 🇦🇺 Brisbane, Queensland, Australia

Fiona Stanley Hospital-Medical Oncology ( Site 0705); 🇦🇺 Murdoch, Western Australia, Australia

Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 1402); 🇦🇹 Linz, Oberosterreich, Austria

Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1400); 🇦🇹 Wien, Austria

Antwerp University Hospital-Thoracic Oncology ( Site 1503); 🇧🇪 Edegem, Antwerpen, Belgium

Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi; 🇧🇪 Yvoir, Namur, Belgium

Liga Norte Riograndense Contra o Câncer ( Site 0301); 🇧🇷 Natal, Rio Grande Do Norte, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0303); 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Hospital Nossa Senhora da Conceição ( Site 0302); 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Instituto de Oncologia Saint Gallen ( Site 0319); 🇧🇷 Santa Cruz do Sul, Rio Grande Do Sul, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0304); 🇧🇷 Barretos, Sao Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0313); 🇧🇷 São José do Rio Preto, Sao Paulo, Brazil

St. Marys Hospital Center ( Site 0107); 🇨🇦 Montreal, Quebec, Canada

Centre Hospitalier de l'Université de Montréal ( Site 0104); 🇨🇦 Montréal, Quebec, Canada

FALP-UIDO ( Site 0401); 🇨🇱 Providencia, Region M. De Santiago, Chile

Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0404); 🇨🇱 Santiago, Region M. De Santiago, Chile

Bradfordhill-Clinical Area ( Site 0400); 🇨🇱 Santiago, Region M. De Santiago, Chile

ONCOCENTRO APYS-ACEREY ( Site 0410); 🇨🇱 Viña del Mar, Valparaiso, Chile

Beijing Cancer hospital-Thoracic Surgery department I ( Site 1301); 🇨🇳 Beijing, Beijing, China

Beijing Peking Union Medical College Hospital-Thoracic surgery department ( Site 1302); 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital. ( Site 1300); 🇨🇳 Beijing, Beijing, China

Fujian Cancer Hospital-oncology department ( Site 1314); 🇨🇳 Fuzhou, Fujian, China

The First Affiliated Hospital of Guangzhou Medical University-thoracic surgery department ( Site 132; 🇨🇳 Guangzhou, Guangdong, China

Southern Medical University Nanfang Hospital-Thoracic surgery department ( Site 1313); 🇨🇳 Guangzhou, Guangdong, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology-Thoracic Surgery; 🇨🇳 Wuhan, Hubei, China

Hubei Cancer Hospital ( Site 1308); 🇨🇳 Wuhan, Hubei, China

Xiangya Hospital Central South University-Thoracic surgery ( Site 1311); 🇨🇳 Changsha, Hunan, China

Nanjing First Hospital ( Site 1310); 🇨🇳 Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University-Thoracic Surgery Department ( Site 1318); 🇨🇳 Suzhou, Jiangsu, China

The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 1330); 🇨🇳 Nanchang, Jiangxi, China

The First Hospital of Jilin University ( Site 1324); 🇨🇳 Changchun, Jilin, China

Sichuan Cancer hospital. ( Site 1327); 🇨🇳 Chengdu, Sichuan, China

The Second People's Hospital of Neijiang ( Site 1322); 🇨🇳 Neijiang, Sichuan, China

Yunnan Province Cancer Hospital ( Site 1315); 🇨🇳 Kunming, Yunnan, China

The first Affiliated Hospital, Zhejiang University School of-Thoracic Cardiovascular Surgery Ward (; 🇨🇳 Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital ( Site 1309); 🇨🇳 Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 1328); 🇨🇳 Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province ( Site 1329); 🇨🇳 Linhai, Zhejiang, China

Ningbo No. 2 Hospital ( Site 1305); 🇨🇳 Ningbo, Zhejiang, China

CHRU de Brest ( Site 1804); 🇫🇷 Brest, Finistere, France

CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 1801); 🇫🇷 Toulouse, Haute-Garonne, France

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1805); 🇫🇷 Limoges, Haute-Vienne, France

Groupe hospitalier Paris saint Joseph. ( Site 1807); 🇫🇷 Paris, Ile-de-France, France

Clinique Teissier Groupe ( Site 1811); 🇫🇷 Valenciennes, Nord, France

Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 1810); 🇫🇷 Clermont-Ferrand, Puy-de-Dome, France

Hospices Civils de Lyon - Hopital Louis Pradel ( Site 1809); 🇫🇷 Bron, Rhone, France

HIA Sainte Anne ( Site 1800); 🇫🇷 Toulon, Var, France

Hôpital Tenon ( Site 1802); 🇫🇷 Paris, France

Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1914); 🇩🇪 Esslingen, Baden-Wurttemberg, Germany

Katholisches Klinikum Koblenz ( Site 1911); 🇩🇪 Koblenz, Rheinland-Pfalz, Germany

Vivantes Hospital Spandau-Klinik für Innere Medizin, Hämatologie, Onkologie und Gastroenterologie- (; 🇩🇪 Berlin, Germany

UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 2006); 🇬🇷 Patras, Achaia, Greece

251 Hellenic Air Force General Hospital ( Site 2003); 🇬🇷 Athens, Attiki, Greece

THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol; 🇬🇷 Athens, Attiki, Greece

Athens Medical Center ( Site 2005); 🇬🇷 Athens, Attiki, Greece

Metaxa Cancer Hospital of Piraeus ( Site 2002); 🇬🇷 Piraeus, Attiki, Greece

University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 2001); 🇬🇷 Heraklion, Irakleio, Greece

University General Hospital of Larissa-Oncology Clinic ( Site 2004); 🇬🇷 Larissa, Thessalia, Greece

Queen Mary Hospital ( Site 3400); 🇭🇰 Hksar, Hong Kong

Queen Elizabeth Hospital ( Site 3402); 🇭🇰 Yau Ma Tei, Hong Kong

Rambam Health Care Campus-Oncology Division ( Site 2203); 🇮🇱 Haifa, Israel

Shaare Zedek Medical Center ( Site 2206); 🇮🇱 Jerusalem, Israel

Rabin Medical Center ( Site 2204); 🇮🇱 Petah Tikva, Israel

Sheba Medical Center ( Site 2200); 🇮🇱 Ramat Gan, Israel

Ospedale San Raffaele-Oncologia Medica ( Site 2311); 🇮🇹 Milano, Italy

Chungbuk National University Hospital-Internal medicine ( Site 1000); 🇰🇷 Cheongju-si, Chungbuk, Korea, Republic of

National Cancer Center-Lung Cancer Center ( Site 1002); 🇰🇷 Goyang-si, Kyonggi-do, Korea, Republic of

Seoul National University Bundang Hospital-Medical Oncology ( Site 1003); 🇰🇷 Seongnam, Kyonggi-do, Korea, Republic of

The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 1001); 🇰🇷 Suwon-si, Kyonggi-do, Korea, Republic of

Keimyung University Dongsan Hospital CRC room 1 ( Site 1006); 🇰🇷 Daegu, Taegu-Kwangyokshi, Korea, Republic of

Asan Medical Center-Lung Cancer Center ( Site 1005); 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center-Division of Hematology/Oncology ( Site 1004); 🇰🇷 Seoul, Korea, Republic of

CIO - Centro de Inmuno-Oncología de Occidente ( Site 0506); 🇲🇽 Guadalajara, Jalisco, Mexico

Isala, locatie Zwolle-Poli Longziekten ( Site 3454); 🇳🇱 Zwolle, Overijssel, Netherlands

Meander Medisch Centrum-Researchbureau Longgeneeskunde ( Site 3458); 🇳🇱 Amersfoort, Utrecht, Netherlands

Erasmus Medisch Centrum ( Site 3452); 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Akershus Universitetssykehus ( Site 2501); 🇳🇴 Lørenskog, Akershus, Norway

Drammen Sykehus, Vestre Viken HF ( Site 2502); 🇳🇴 Drammen, Buskerud, Norway

Sykehuset Innlandet HF Gjøvik ( Site 2503); 🇳🇴 Gjøvik, Oppland, Norway

IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 0604); 🇵🇪 Lima, Peru

Oncosalud ( Site 0602); 🇵🇪 Lima, Peru

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 2601); 🇵🇱 Przemysl, Podkarpackie, Poland

Bialostockie Centrum Onkologii ( Site 2604); 🇵🇱 Bialystok, Podlaskie, Poland

Uniwersyteckie Centrum Kliniczne ( Site 2610); 🇵🇱 Gdansk, Pomorskie, Poland

UNIDADE LOCAL DE SAUDE DE MATOSINHOS-Serviço de Oncologia ( Site 2705); 🇵🇹 Matosinhos, Porto, Portugal

Spitalul Universitar de Urgență Elias ( Site 2804); 🇷🇴 București, Bucuresti, Romania

Cardiomed SRL Cluj-Napoca-Medical Oncology ( Site 2801); 🇷🇴 Cluj-Napoca, Cluj, Romania

SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2802); 🇷🇴 Florești, Cluj, Romania

SC ONCO CARD SRL ( Site 2808); 🇷🇴 Brasov, Romania

Hospital Insular de Gran Canaria-Oncology ( Site 2903); 🇪🇸 Las Palmas de Gran Canaria, Las Palmas, Spain

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2902); 🇪🇸 Pozuelo de Alarcon, Madrid, Spain

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2900); 🇪🇸 Barcelona, Spain

Hospital Clinico San Carlos-Oncology Department ( Site 2904); 🇪🇸 Madrid, Spain

Kantonsspital Graubünden-Medizin ( Site 3006); 🇨🇭 Chur, Grisons, Switzerland

Kantonsspital Münsterlingen - Spital Thurgau AG ( Site 3005); 🇨🇭 Munsterlingen, Thurgau, Switzerland

National Taiwan University Cancer Center (NTUCC) ( Site 1105); 🇨🇳 Taipei City, Taipei, Taiwan

Tri-Service General Hospital ( Site 1100); 🇨🇳 Taipei City, Taipei, Taiwan

Taoyuan General Hospital ( Site 1106); 🇨🇳 Taoyuan City, Taoyuan, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 1103); 🇨🇳 Kaohsiung, Taiwan

Taichung Veterans General Hospital-Chest ( Site 1101); 🇨🇳 Taichung, Taiwan

National Cheng Kung University Hospital-Clinical Trial Center ( Site 1102); 🇨🇳 Tainan, Taiwan

National Taiwan University Hospital-Oncology ( Site 1104); 🇨🇳 Taipei, Taiwan

Hacettepe Universite Hastaneleri-oncology hospital ( Site 3101); 🇹🇷 Ankara, Turkey

Memorial Ankara Hastanesi-Medical Oncology ( Site 3110); 🇹🇷 Ankara, Turkey