Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)

Phase 3

Recruiting

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

• Registration Number: NCT06074588
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-03
• Study First Posted: 2023-10-10
• Study Start: 2023-11-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16
• Primary Completion: 2027-05-10
• Study Completion: 2030-03-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 556

Inclusion Criteria

• Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations.
• Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1.
• Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation; and 1 platinum-based therapy after progression on or after EGFR TKI.
• Measurable disease per RECIST 1.1 as assessed by the local site investigator.
• Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
• Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline.
• Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
• Have an ECOG performance status of 0 or 1 within 3 days before randomization.

Exclusion Criteria

• Has predominantly squamous cell histology NSCLC.
• Has mixed tumor(s) with small cell elements.
• Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
• 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 uncontrolled, significant cardiovascular disease or cerebrovascular disease.
• Has an EGFR T790M mutation and has not received a third generation EGFR TKI (eg, osimertinib).
• Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before randomization.
• Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
• Completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
• Received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study intervention.
• Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC).
• Received prior treatment with a topoisomerase I-containing ADC.
• Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
• Known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Active infection requiring systemic therapy.
• History of noninfectious pneumonitis/ILD that required steroids or has current pneumonitis/ILD.
• Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks, and are off steroids 3 days prior to dosing with study medication.
• HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
• Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sacituzumab tirumotecan	Sacituzumab tirumotecan	Participants will receive 4 mg/kg of sacituzumab tirumotecan via intravenous (IV) infusion on Days 1, 15 and 29 of each 6-week cycle. 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.
Chemotherapy	Docetaxel	Participants will receive 75 mg/m\^2 of docetaxel or 500 mg/m\^2 of pemetrexed by IV infusion on Days 1 and 22 of every 6-week cycle.
Chemotherapy	Pemetrexed	Participants will receive 75 mg/m\^2 of docetaxel or 500 mg/m\^2 of pemetrexed by IV infusion on Days 1 and 22 of every 6-week cycle.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) of Participants with NSCLC with Epidermal Growth Factor Receptor (EGFR) Mutations	Up to approximately 35 months	PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review (BICR) or death due to any cause, whichever occurs first.
Overall Survival (OS) of Participants with NSCLC with EGFR mutations	Up to approximately 41 months	OS is defined as the time from randomization to death due to any cause.

Secondary Outcome Measures

Name	Time	Method
OS of All Participants with NSCLC	Up to approximately 41 months	OS is defined as the time from randomization to death due to any cause.
Objective Response Rate (ORR) of Participants with NSCLC with EGFR Mutations	Up to approximately 35 months	ORR was defined as the percentage of participants who had 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) as assessed using RECIST 1.1. based on BICR in NSCLC with EGFR mutations.
ORR of All Participants with NSCLC	Up to approximately 35 months	ORR was defined as the percentage of participants who had 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) as assessed using RECIST 1.1. based on BICR in all participants with NSCLC.
PFS of All Participants with NSCLC	Up to approximately 35 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.
Duration of Response (DOR) of All Participants with NSCLC	Up to approximately 6 years	For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR in all participants with NSCLC, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Change in Score from Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)	Baseline and up to approximately 48 weeks	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. The change from baseline in the dyspnea (EORTC QLQ-C30 Item 8) score will be presented.
TTD from Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer 13 [QLQ-LC13] Item 31)	Up to approximately 48 weeks	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.
Time to Deterioration from Baseline in Chest Pain (EORTC QLQ-LC13 Item 40)	Up to approximately 48 weeks	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.
Change in Score from Baseline in Global Health Status/QoL Score (European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire-Core 30 [QLQ-C30] Items 29 and 30)	Baseline and up to approximately 48 weeks	The EORTC QLQ-C30 is a questionnaire to assess the overall health status and 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?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status and quality of life. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
Change in Score from Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer 13 [QLQ-LC13] Item 31)	Baseline and up to approximately 48 weeks	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?" 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 cough (EORTC QLQ-LC13 Item 31) score will be presented. A lower score indicates a better outcome.
Time to Deterioration (TTD) from Baseline in Global Health Status/QoL Score (EORTC QLQ-C30 Items 29 and 30)	Up to approximately 48 weeks	The EORTC QLQ-C30 is a questionnaire to assess the overall health status and 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?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status and quality of life. 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.
TTD from Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)	Up to approximately 48 weeks	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.
Number of Participants Who Experience One or More Adverse Events (AEs)	Up to approximately 6 years	An AE is defined as 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 Who Discontinue Study Treatment Due to an Adverse Event (AE)	Up to approximately 4 years	An AE is defined as 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 in Chest Pain (EORTC QLQ-LC13 Item 40)	Baseline and up to approximately 48 weeks	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.

Trial Locations

Locations (184)

UCLA Hematology/Oncology - Santa Monica ( Site 0023); 🇺🇸 Los Angeles, California, United States

Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0001); 🇺🇸 Jacksonville, Florida, United States

Mid Florida Hematology and Oncology Center ( Site 0005); 🇺🇸 Orange City, Florida, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003); 🇺🇸 Marietta, Georgia, United States

Karmanos Cancer Institute ( Site 0018); 🇺🇸 Detroit, Michigan, United States

Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0027); 🇺🇸 Rochester, Minnesota, United States

Hattiesburg Clinic Hematology/Oncology ( Site 0010); 🇺🇸 Hattiesburg, Mississippi, United States

University Of Nebraska Medical Center ( Site 0011); 🇺🇸 Omaha, Nebraska, United States

Capital Health Medical Center - Hopewell ( Site 0006); 🇺🇸 Pennington, New Jersey, United States

University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0015); 🇺🇸 Cincinnati, Ohio, United States

VCU Health Adult Outpatient Pavillion ( Site 0026); 🇺🇸 Richmond, Virginia, United States

St. George Private Hospital ( Site 3004); 🇦🇺 Kogarah, New South Wales, Australia

Westmead Hospital ( Site 3000); 🇦🇺 Westmead, New South Wales, Australia

Monash Health-Oncology Research ( Site 3001); 🇦🇺 Clayton, Victoria, Australia

Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 3003); 🇦🇺 Melbourne, Victoria, Australia

Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0447); 🇧🇷 Natal, Rio Grande Do Norte, Brazil

Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0440); 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0444); 🇧🇷 Barretos, Sao Paulo, Brazil

Hospital Paulistano-Americas Oncologia ( Site 0441); 🇧🇷 Sao Paulo, Brazil

A. C. Camargo Cancer Center-CAPEC ( Site 0442); 🇧🇷 Sao Paulo, Brazil

Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0446); 🇧🇷 Sao Paulo, Brazil

William Osler Health System ( Site 0205); 🇨🇦 Brampton, Ontario, Canada

Princess Margaret Cancer Centre ( Site 0204); 🇨🇦 Toronto, Ontario, Canada

Centro Investigacion Cancer James Lind ( Site 0513); 🇨🇱 Temuco, Araucania, Chile

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

Clínica RedSalud Vitacura ( Site 0511); 🇨🇱 Santiago., Region M. De Santiago, Chile

Centro de Estudios Clínicos SAGA ( Site 0517); 🇨🇱 Santiago, Region M. De Santiago, Chile

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

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

K2 Oncology ( Site 0514); 🇨🇱 Santiago, Region M. De Santiago, Chile

Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0502); 🇨🇱 Santiago, Region M. De Santiago, Chile

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

ONCOCENTRO APYS-ACEREY ( Site 0500); 🇨🇱 Viña del Mar, Valparaiso, Chile

Anhui Provincial Cancer Hospital ( Site 2830); 🇨🇳 Hefei, Anhui, China

Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2810); 🇨🇳 Beijing, Beijing, China

Beijing Peking Union Medical College Hospital-pneumology department ( Site 2815); 🇨🇳 Beijing, Beijing, China

Chongqing University Cancer Hospital-Medical Oncology ( Site 2814); 🇨🇳 Chongqing, Chongqing, China

Fujian Cancer Hospital ( Site 2819); 🇨🇳 Fuzhou, Fujian, China

The First Affiliated hospital of Xiamen University ( Site 2820); 🇨🇳 Xiamen, Fujian, China

Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 2818); 🇨🇳 Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital-Respiratory Oncology ( Site 2816); 🇨🇳 Nanning, Guangxi, China

Harbin Medical University Cancer Hospital-oncology of department ( Site 2807); 🇨🇳 Harbin, Heilongjiang, China

Henan Cancer Hospital-henan cancer hospital ( Site 2813); 🇨🇳 Zhengzhou, Henan, China

Tongji Hospital Tongji Medical,Science & Technology ( Site 2805); 🇨🇳 Wuhan, Hubei, China

Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2806); 🇨🇳 Wuhan, Hubei, China

Hubei Cancer Hospital ( Site 2809); 🇨🇳 Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University ( Site 2827); 🇨🇳 Changsha, Hunan, China

Hunan Cancer Hospital-thoracic oncology II ( Site 2808); 🇨🇳 Changsha, Hunan, China

Nanjing Drum Tower Hospital ( Site 2812); 🇨🇳 Nangjing, Jiangsu, China

The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2821); 🇨🇳 Nanchang, Jiangxi, China

Jilin Province Tumor Hospital-clinical research ( Site 2803); 🇨🇳 Changchun, Jilin, China

The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2817); 🇨🇳 Xi'an, Shaanxi, China

Jinan Central Hospital-oncology department ( Site 2802); 🇨🇳 Jinan, Shandong, China

LinYi Cancer Hospital ( Site 2804); 🇨🇳 Linyi, Shandong, China

Shanghai Chest Hospital-Oncology department ( Site 2800); 🇨🇳 Shanghai, Shanghai, China

Fudan University Shanghai Cancer Center-Oncology ( Site 2811); 🇨🇳 Shanghai, Shanghai, China

West China Hospital, Sichuan University-Lung cancer center ( Site 2826); 🇨🇳 Cheng Du, Sichuan, China

Sichuan Cancer hospital. ( Site 2822); 🇨🇳 Chengdu, Sichuan, China

Yunnan Province Cancer Hospital ( Site 2824); 🇨🇳 Kunming, Yunnan, China

Sir Run Run Shaw Hospital School of Medicine Zhejiang University ( Site 2828); 🇨🇳 Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital ( Site 2829); 🇨🇳 Hangzhou, Zhejiang, China

Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 1100); 🇨🇿 Brno, Brno-mesto, Czechia

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

Fakultni nemocnice Plzen ( Site 1104); 🇨🇿 Pilsen, Plzensky Kraj, Czechia

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

Vseobecna fakultni nemocnice v Praze-Onkologicka klinika ( Site 1105); 🇨🇿 Praha 2, Czechia

Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1303); 🇫🇷 Bordeaux, Aquitaine, France

CHU Charles Nicolle-pneumology, intensive care and thoracic oncology ( Site 1300); 🇫🇷 Rouen, Haute-Normandie, France

CENTRE LEON BERARD ( Site 1305); 🇫🇷 Lyon Cedex08, Rhone-Alpes, France

Institut Curie-Thorax Institute ( Site 1304); 🇫🇷 Paris, France

Universitätsmedizin Göttingen - Georg-August-Universität-Klinik für Hämatologie und Medizinische On ( Site 1407); 🇩🇪 Goettingen, Niedersachsen, Germany

Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 1400); 🇩🇪 Essen, Nordrhein-Westfalen, Germany

Klinikum Chemnitz - Flemmingstraße ( Site 1401); 🇩🇪 Chemnitz, Sachsen, Germany

Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1402); 🇩🇪 Dresden, Sachsen, Germany

Asklepios Klinik Harburg ( Site 1403); 🇩🇪 Hamburg, Germany

Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 2705); 🇬🇷 Athens, Attiki, Greece

THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 2700); 🇬🇷 Athens, Attiki, Greece

Aretaieio Hospital ( Site 2702); 🇬🇷 Athens, Attiki, Greece

ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 2704); 🇬🇷 Chaidari, Athens, Attiki, Greece

"Theagenio" Cancer Hospital of Thessaloniki ( Site 2703); 🇬🇷 Thessaloniki, Kentriki Makedonia, Greece

Papageorgiou General Hospital of Thessaloniki ( Site 2701); 🇬🇷 Thessaloniki, Greece

Hong Kong Integrated Oncology Centre ( Site 3200); 🇭🇰 Central, Hong Kong

Queen Mary Hospital ( Site 3203); 🇭🇰 Hksar, Hong Kong

Queen Elizabeth Hospital-Department of Clinical Oncology ( Site 3204); 🇭🇰 Kowloon, Hong Kong

Princess Margaret Hospital-Department of Oncology ( Site 3201); 🇭🇰 Lai Chi Kok, Hong Kong

Rambam Health Care Campus-Oncology Division ( Site 1702); 🇮🇱 Haifa, Israel

Shaare Zedek Medical Center ( Site 1700); 🇮🇱 Jerusalem, Israel

Rabin Medical Center ( Site 1703); 🇮🇱 Petah Tikva, Israel

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1806); 🇮🇹 Meldola, Emilia-Romagna, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1802); 🇮🇹 Roma, Lazio, Italy

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

Istituto Clinico Humanitas ( Site 1803); 🇮🇹 Rozzano, Lombardia, Italy

Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1805); 🇮🇹 Rome, Roma, Italy

Aichi Cancer Center ( Site 3400); 🇯🇵 Nagoya, Aichi, Japan

Fujita Health University Hospital ( Site 3419); 🇯🇵 Toyoake, Aichi, Japan

National Cancer Center Hospital East ( Site 3406); 🇯🇵 Kashiwa, Chiba, Japan

National Hospital Organization Shikoku Cancer Center ( Site 3415); 🇯🇵 Matsuyama, Ehime, Japan

Gunma Prefectural Cancer Center ( Site 3418); 🇯🇵 Otashi, Gunma, Japan

Takarazuka City Hospital ( Site 3409); 🇯🇵 Takarazuka, Hyogo, Japan

Kanazawa University Hospital ( Site 3414); 🇯🇵 Kanazawa, Ishikawa, Japan

Kanagawa Cancer Center ( Site 3404); 🇯🇵 Yokohama, Kanagawa, Japan

Miyagi Cancer Center ( Site 3416); 🇯🇵 Natori, Miyagi, Japan

Sendai Kousei Hospital ( Site 3401); 🇯🇵 Sendai, Miyagi, Japan

Niigata Cancer Center Hospital ( Site 3405); 🇯🇵 Niigata-shi, Niigata, Japan

Kansai Medical University Hospital ( Site 3410); 🇯🇵 Hirakata, Osaka, Japan

Shizuoka Cancer Center ( Site 3403); 🇯🇵 Nagaizumi-cho,Sunto-gun, Shizuoka, Japan

Cancer Institute Hospital of JFCR ( Site 3402); 🇯🇵 Koto, Tokyo, Japan

Chiba University Hospital ( Site 3411); 🇯🇵 Chiba, Japan

National Hospital Organization Kyushu Medical Center ( Site 3412); 🇯🇵 Fukuoka, Japan

Kyushu University Hospital ( Site 3407); 🇯🇵 Fukuoka, Japan

Okayama University Hospital ( Site 3417); 🇯🇵 Okayama, Japan

Osaka International Cancer Institute ( Site 3413); 🇯🇵 Osaka, Japan

Nippon Medical School Hospital ( Site 3408); 🇯🇵 Tokyo, Japan

Chungbuk National University Hospital-Internal medicine ( Site 3809); 🇰🇷 Cheongju-si, Chungbuk, Korea, Republic of

Chonnam National University Hwasun Hospital-Pulmonology ( Site 3807); 🇰🇷 Hwasun, Jeonranamdo, Korea, Republic of

National Cancer Center-Lung Cancer Center ( Site 3810); 🇰🇷 Goyang-si, Kyonggi-do, Korea, Republic of

Seoul National University Bundang Hospital ( Site 3806); 🇰🇷 Seongnam, Kyonggi-do, Korea, Republic of

The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3803); 🇰🇷 Suwon-si, Kyonggi-do, Korea, Republic of

Pusan National University Yangsan Hospital-Lung Cancer Clinic ( Site 3811); 🇰🇷 Yangsan, Kyongsangnam-do, Korea, Republic of

Pusan National University Hospital ( Site 3805); 🇰🇷 Busan, Pusan-Kwangyokshi, Korea, Republic of

Chungnam national university hospital ( Site 3808); 🇰🇷 Jung-gu, Taejon-Kwangyokshi, Korea, Republic of

Kangbuk Samsung Hospital ( Site 3813); 🇰🇷 Seoul, Korea, Republic of

Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 3804); 🇰🇷 Seoul, Korea, Republic of

Konkuk University Medical Center ( Site 3812); 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center ( Site 3801); 🇰🇷 Seoul, Korea, Republic of

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

Korea University Guro Hospital-Internal Medicine ( Site 3800); 🇰🇷 Seoul, Korea, Republic of

Hospital Raja Perempuan Zainab II-Medical Department ( Site 3502); 🇲🇾 Kota Bharu, Kelantan, Malaysia

National Cancer Institute-Radiotherapy and Oncology ( Site 3504); 🇲🇾 Putrajaya, Kuala Lumpur, Malaysia

Sarawak General Hospital-Radiotherapy Unit ( Site 3500); 🇲🇾 Kuching, Sarawak, Malaysia

CIO - Centro de Inmuno-Oncología de Occidente ( Site 0706); 🇲🇽 Guadalajara, Jalisco, Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Hematologia and Oncologia ( Site 0704); 🇲🇽 Monterrey, Nuevo Leon, Mexico

Centro de Investigacion Clinica de Oaxaca ( Site 0701); 🇲🇽 Oaxaca de Juarez, Oaxaca, Mexico

Clinica Integral Internacional de Oncología ( Site 0705); 🇲🇽 Puebla, Mexico

THE MEDICAL CITY ILOILO-The Medical City Iloilo - Clinical and Translational Research Institute-Ilo ( Site 3600); 🇵🇭 Iloilo City, Iloilo, Philippines

Manila Doctors Hospital-Clinical Trial Office ( Site 3604); 🇵🇭 Manila, National Capital Region, Philippines

Asian Hospital and Medical Center ( Site 3605); 🇵🇭 Muntinlupa, National Capital Region, Philippines

THE MEDICAL CITY-Cancer Research Center ( Site 3603); 🇵🇭 Pasig, National Capital Region, Philippines

ST. LUKE'S MEDICAL CENTER ( Site 3601); 🇵🇭 Quezon City, National Capital Region, Philippines

CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 3602); 🇵🇭 San Juan City, Metro Manila, National Capital Region, Philippines

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

Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 2009); 🇵🇱 Torun, Kujawsko-pomorskie, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000); 🇵🇱 Warszawa, Mazowieckie, Poland

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

Narodowy Instytut Onkologii - Oddzial w Gliwicach-II Klinika Radioterapi i Chemioterapii ( Site 2002); 🇵🇱 Gliwice, Slaskie, Poland

Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2005); 🇵🇱 Kielce, Swietokrzyskie, Poland

HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2304); 🇪🇸 Barcelona, Cataluna, Spain

Hospital Insular de Gran Canaria-Oncology ( Site 2305); 🇪🇸 Las Palmas de Gran Canaria, Las Palmas, Spain

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2303); 🇪🇸 Madrid, Madrid, Comunidad De, Spain

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2301); 🇪🇸 Pozuelo de Alarcon, Madrid, Spain

H.R.U Málaga - Hospital General-Oncology ( Site 2302); 🇪🇸 Málaga, Malaga, Spain

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2300); 🇪🇸 Barcelona, Spain

Clinica Universidad de Navarra-Medical Oncology ( Site 2306); 🇪🇸 Madrid, Spain

Changhua Christian Hospital ( Site 3908); 🇨🇳 Changhua County, Changhua, Taiwan

Chang Gung Memorial Hospital at Kaohsiung ( Site 3906); 🇨🇳 Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan

Chi Mei Medical Center ( Site 3910); 🇨🇳 Tainan City, Tainan, Taiwan

National Taiwan University Cancer Center (NTUCC) ( Site 3903); 🇨🇳 Taipei City, Taipei, Taiwan

National Taiwan University Hospital - Hsinchu branch ( Site 3907); 🇨🇳 Hsinchu, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3912); 🇨🇳 Kaohsiung, Taiwan

E-Da hospital ( Site 3911); 🇨🇳 Kaohsiung, Taiwan

National Cheng Kung University Hospital ( Site 3909); 🇨🇳 Tainan, Taiwan

National Taiwan University Hospital-Oncology ( Site 3904); 🇨🇳 Taipei, Taiwan

Mackay Memorial Hospital-Chest Medicine ( Site 3902); 🇨🇳 Taipei, Taiwan

Taipei Medical University Hospital ( Site 3900); 🇨🇳 Taipei, Taiwan

Maharaj Nakorn Chiang Mai Hospital ( Site 4003); 🇹🇭 Muang, Chiang Mai, Thailand

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

Lampang Cancer Hospital ( Site 4005); 🇹🇭 Muang, Lampang, Thailand

Songklanagarind hospital ( Site 4001); 🇹🇭 HatYai, Songkhla, Thailand

Faculty of Medicine - Khon Kaen University ( Site 4004); 🇹🇭 Khon Kaen, Thailand

Sunpasitthiprasong Hospital-Oncology ( Site 4002); 🇹🇭 Ubon Ratchathani, Thailand

Medipol Mega Universite Hastanesi-oncology ( Site 2505); 🇹🇷 Stanbul, Istanbul, Turkey

Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2504); 🇹🇷 Bornova, Izmir, Turkey

Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500); 🇹🇷 Ankara, Turkey

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2501); 🇹🇷 Ankara, Turkey

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

ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2606); 🇬🇧 London, Kensington And Chelsea, United Kingdom

St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2600); 🇬🇧 London, London, City Of, United Kingdom

Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 2603); 🇬🇧 London, London, City Of, United Kingdom

Royal Marsden Hospital (Sutton) ( Site 2605); 🇬🇧 Sutton., Surrey, United Kingdom

The Christie NHS Foundation Trust ( Site 2604); 🇬🇧 Manchester, United Kingdom

The Clatterbridge Cancer Centre ( Site 2602); 🇬🇧 Wirral, United Kingdom

Hanoi Oncology Hospital ( Site 4102); 🇻🇳 Hanoi, Ha Noi, Vietnam

K Hospital - National Cancer Hospital ( Site 4105); 🇻🇳 Hanoi, Ha Noi, Vietnam

National Lung Hospital-Oncology Department ( Site 4104); 🇻🇳 Hanoi, Ha Noi, Vietnam