Clinical trial NCT06074588: 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)
Official title: A Randomized, Open-label, Phase 3 Study of MK-2870 vs Chemotherapy (Docetaxel or Pemetrexed) in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: Anaplastic lymphoma kinase (ALK)
Antibody-drug conjugate (ADC)
Epidermal growth factor receptor (EGFR)
Trophoblast cell-surface antigen 2 (TROP2)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 556
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

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.

Primary outcomes:
measure: Progression-free Survival (PFS) of Participants with NSCLC with Epidermal Growth Factor Receptor (EGFR) Mutations
timeFrame: Up to approximately 35 months
measure: Overall Survival (OS) of Participants with NSCLC with EGFR mutations
timeFrame: Up to approximately 41 months
Secondary outcomes:
measure: PFS of All Participants with NSCLC
timeFrame: Up to approximately 35 months
measure: OS of All Participants with NSCLC
timeFrame: Up to approximately 41 months
measure: Objective Response Rate (ORR) of Participants with NSCLC with EGFR Mutations
timeFrame: Up to approximately 35 months
measure: ORR of All Participants with NSCLC
timeFrame: Up to approximately 35 months
measure: Duration of Response (DOR) of All Participants with NSCLC
timeFrame: Up to approximately 6 years
measure: 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)
timeFrame: Baseline and up to approximately 48 weeks
measure: Change in Score from Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)
timeFrame: Baseline and up to approximately 48 weeks
measure: Change in Score from Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer 13 [QLQ-LC13] Item 31)
timeFrame: Baseline and up to approximately 48 weeks
measure: Change in Score from Baseline in Chest Pain (EORTC QLQ-LC13 Item 40)
timeFrame: Baseline and up to approximately 48 weeks
measure: Time to Deterioration (TTD) from Baseline in Global Health Status/QoL Score (EORTC QLQ-C30 Items 29 and 30)
timeFrame: Up to approximately 48 weeks
measure: TTD from Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)
timeFrame: Up to approximately 48 weeks
measure: TTD from Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer 13 [QLQ-LC13] Item 31)
timeFrame: Up to approximately 48 weeks
measure: Time to Deterioration from Baseline in Chest Pain (EORTC QLQ-LC13 Item 40)
timeFrame: Up to approximately 48 weeks
measure: Number of Participants Who Experience One or More Adverse Events (AEs)
timeFrame: Up to approximately 6 years
measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to approximately 4 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Santa Monica ( Site 0023)
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0001)
state: Florida
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology Center ( Site 0005)
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003)
state: Georgia
city: Detroit
country: United States
facility: Karmanos Cancer Institute ( Site 0018)
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0027)
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology/Oncology ( Site 0010)
state: Mississippi
city: Omaha
country: United States
facility: University Of Nebraska Medical Center ( Site 0011)
state: Nebraska
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center ( Site 0033)
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Health System Morristown Medical Center ( Site 0031)
state: New Jersey
city: Pennington
country: United States
facility: Capital Health Medical Center - Hopewell ( Site 0006)
state: New Jersey
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0015)
state: Ohio
city: Richmond
country: United States
facility: VCU Health Adult Outpatient Pavillion ( Site 0026)
state: Virginia
city: Kogarah
country: Australia
facility: St. George Private Hospital ( Site 3004)
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital ( Site 3000)
state: New South Wales
city: Clayton
country: Australia
facility: Monash Health-Oncology Research ( Site 3001)
state: Victoria
city: Melbourne
country: Australia
facility: Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 3003)
state: Victoria
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0447)
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0440)
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0444)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Paulistano-Americas Oncologia ( Site 0441)
city: Sao Paulo
country: Brazil
facility: A. C. Camargo Cancer Center-CAPEC ( Site 0442)
city: Sao Paulo
country: Brazil
facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0446)
city: Brampton
country: Canada
facility: William Osler Health System ( Site 0205)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0204)
state: Ontario
city: Temuco
country: Chile
facility: Centro Investigacion Cancer James Lind ( Site 0513)
state: Araucania
city: Talca
country: Chile
facility: Clinica Universidad Catolica del Maule-Oncology ( Site 0501)
state: Maule
city: Santiago.
country: Chile
facility: Clínica RedSalud Vitacura ( Site 0511)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Centro de Estudios Clínicos SAGA ( Site 0517)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Orlandi Oncologia-Oncology ( Site 0504)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: FALP-UIDO ( Site 0509)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: K2 Oncology ( Site 0514)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0502)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill-Clinical Area ( Site 0507)
state: Region M. De Santiago
city: Viña del Mar
country: Chile
facility: ONCOCENTRO APYS-ACEREY ( Site 0500)
state: Valparaiso
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital ( Site 2830)
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2810)
state: Beijing
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital-pneumology department ( Site 2815)
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital-Medical Oncology ( Site 2814)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital ( Site 2819)
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated hospital of Xiamen University ( Site 2820)
state: Fujian
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 2818)
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital-Respiratory Oncology ( Site 2816)
state: Guangxi
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital-oncology of department ( Site 2807)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital-henan cancer hospital ( Site 2813)
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 2805)
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2806)
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital ( Site 2809)
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University ( Site 2827)
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital-thoracic oncology II ( Site 2808)
state: Hunan
city: Nangjing
country: China
facility: Nanjing Drum Tower Hospital ( Site 2812)
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2821)
state: Jiangxi
city: Changchun
country: China
facility: Jilin Province Tumor Hospital-clinical research ( Site 2803)
state: Jilin
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2817)
state: Shaanxi
city: Jinan
country: China
facility: Jinan Central Hospital-oncology department ( Site 2802)
state: Shandong
city: Linyi
country: China
facility: LinYi Cancer Hospital ( Site 2804)
state: Shandong
city: Shanghai
country: China
facility: Shanghai Chest Hospital-Oncology department ( Site 2800)
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center-Oncology ( Site 2811)
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital, Sichuan University-Lung cancer center ( Site 2826)
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Cancer hospital. ( Site 2822)
state: Sichuan
city: Kunming
country: China
facility: Yunnan Province Cancer Hospital ( Site 2824)
state: Yunnan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital School of Medicine Zhejiang University ( Site 2828)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 2829)
state: Zhejiang
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 1100)
state: Brno-mesto
city: Ostrava
country: Czechia
facility: Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni odd ( Site 1103)
state: Ostrava Mesto
city: Pilsen
country: Czechia
facility: Fakultni nemocnice Plzen ( Site 1104)
state: Plzensky Kraj
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 1102)
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze-Onkologicka klinika ( Site 1105)
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1303)
state: Aquitaine
city: Rouen
country: France
facility: CHU Charles Nicolle-pneumology, intensive care and thoracic oncology ( Site 1300)
state: Haute-Normandie
city: Lyon Cedex08
country: France
facility: CENTRE LEON BERARD ( Site 1305)
state: Rhone-Alpes
city: Paris
country: France
facility: Institut Curie-Thorax Institute ( Site 1304)
city: Goettingen
country: Germany
facility: Universitätsmedizin Göttingen - Georg-August-Universität-Klinik für Hämatologie und Medizinische On ( Site 1407)
state: Niedersachsen
city: Essen
country: Germany
facility: Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 1400)
state: Nordrhein-Westfalen
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz - Flemmingstraße ( Site 1401)
state: Sachsen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1402)
state: Sachsen
city: Hamburg
country: Germany
facility: Asklepios Klinik Harburg ( Site 1403)
city: Athens
country: Greece
facility: Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 2705)
state: Attiki
city: Athens
country: Greece
facility: THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 2700)
state: Attiki
city: Athens
country: Greece
facility: Aretaieio Hospital ( Site 2702)
state: Attiki
city: Chaidari, Athens
country: Greece
facility: ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 2704)
state: Attiki
city: Thessaloniki
country: Greece
facility: "Theagenio" Cancer Hospital of Thessaloniki ( Site 2703)
state: Kentriki Makedonia
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital of Thessaloniki ( Site 2701)
city: Central
country: Hong Kong
facility: Hong Kong Integrated Oncology Centre ( Site 3200)
city: Hksar
country: Hong Kong
facility: Queen Mary Hospital ( Site 3203)
city: Kowloon
country: Hong Kong
facility: Queen Elizabeth Hospital-Department of Clinical Oncology ( Site 3204)
city: Lai Chi Kok
country: Hong Kong
facility: Princess Margaret Hospital-Department of Oncology ( Site 3201)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology Division ( Site 1702)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center ( Site 1700)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 1703)
city: Meldola
country: Italy
facility: IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1806)
state: Emilia-Romagna
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1802)
state: Lazio
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1800)
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas ( Site 1803)
state: Lombardia
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1805)
state: Roma
city: Nagoya
country: Japan
facility: Aichi Cancer Center ( Site 3400)
state: Aichi
city: Toyoake
country: Japan
facility: Fujita Health University Hospital ( Site 3419)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 3406)
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 3415)
state: Ehime
city: Otashi
country: Japan
facility: Gunma Prefectural Cancer Center ( Site 3418)
state: Gunma
city: Takarazuka
country: Japan
facility: Takarazuka City Hospital ( Site 3409)
state: Hyogo
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital ( Site 3414)
state: Ishikawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 3404)
state: Kanagawa
city: Natori
country: Japan
facility: Miyagi Cancer Center ( Site 3416)
state: Miyagi
city: Sendai
country: Japan
facility: Sendai Kousei Hospital ( Site 3401)
state: Miyagi
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital ( Site 3405)
state: Niigata
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 3410)
state: Osaka
city: Nagaizumi-cho,Sunto-gun
country: Japan
facility: Shizuoka Cancer Center ( Site 3403)
state: Shizuoka
city: Koto
country: Japan
facility: Cancer Institute Hospital of JFCR ( Site 3402)
state: Tokyo
city: Chiba
country: Japan
facility: Chiba University Hospital ( Site 3411)
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center ( Site 3412)
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 3407)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 3417)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 3413)
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital ( Site 3408)
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital-Internal medicine ( Site 3809)
state: Chungbuk
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital-Pulmonology ( Site 3807)
state: Jeonranamdo
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center-Lung Cancer Center ( Site 3810)
state: Kyonggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 3806)
state: Kyonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3803)
state: Kyonggi-do
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital-Lung Cancer Clinic ( Site 3811)
state: Kyongsangnam-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital ( Site 3805)
state: Pusan-Kwangyokshi
city: Jung-gu
country: Korea, Republic of
facility: Chungnam national university hospital ( Site 3808)
state: Taejon-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital ( Site 3813)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 3804)
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center ( Site 3812)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 3801)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center-Division of Hematology/Oncology ( Site 3802)
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital-Internal Medicine ( Site 3800)
city: Kota Bharu
country: Malaysia
facility: Hospital Raja Perempuan Zainab II-Medical Department ( Site 3502)
state: Kelantan
city: Putrajaya
country: Malaysia
facility: National Cancer Institute-Radiotherapy and Oncology ( Site 3504)
state: Kuala Lumpur
city: Kuching
country: Malaysia
facility: Sarawak General Hospital-Radiotherapy Unit ( Site 3500)
state: Sarawak
city: Guadalajara
country: Mexico
facility: CIO - Centro de Inmuno-Oncología de Occidente ( Site 0706)
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Hematologia and Oncologia ( Site 0704)
state: Nuevo Leon
city: Oaxaca de Juarez
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca ( Site 0701)
state: Oaxaca
city: Puebla
country: Mexico
facility: Clinica Integral Internacional de Oncología ( Site 0705)
city: Iloilo City
country: Philippines
facility: THE MEDICAL CITY ILOILO-The Medical City Iloilo - Clinical and Translational Research Institute-Ilo ( Site 3600)
state: Iloilo
city: Manila
country: Philippines
facility: Manila Doctors Hospital-Clinical Trial Office ( Site 3604)
state: National Capital Region
city: Muntinlupa
country: Philippines
facility: Asian Hospital and Medical Center ( Site 3605)
state: National Capital Region
city: Pasig
country: Philippines
facility: THE MEDICAL CITY-Cancer Research Center ( Site 3603)
state: National Capital Region
city: Quezon City
country: Philippines
facility: ST. LUKE'S MEDICAL CENTER ( Site 3601)
state: National Capital Region
city: San Juan City, Metro Manila
country: Philippines
facility: CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 3602)
state: National Capital Region
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003)
state: Kujawsko-pomorskie
city: Torun
country: Poland
facility: Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 2009)
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2000)
state: Mazowieckie
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001)
state: Podkarpackie
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach-II Klinika Radioterapi i Chemioterapii ( Site 2002)
state: Slaskie
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2005)
state: Swietokrzyskie
city: Barcelona
country: Spain
facility: HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2304)
state: Cataluna
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Insular de Gran Canaria-Oncology ( Site 2305)
state: Las Palmas
city: Madrid
country: Spain
facility: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2303)
state: Madrid, Comunidad De
city: Pozuelo de Alarcon
country: Spain
facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2301)
state: Madrid
city: Málaga
country: Spain
facility: H.R.U Málaga - Hospital General-Oncology ( Site 2302)
state: Malaga
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2300)
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra-Medical Oncology ( Site 2306)
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung ( Site 3906)
state: Kaohsiung
city: Tainan City
country: Taiwan
facility: Chi Mei Medical Center ( Site 3910)
state: Tainan
city: Taipei City
country: Taiwan
facility: National Taiwan University Cancer Center (NTUCC) ( Site 3903)
state: Taipei
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital ( Site 3908)
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital - Hsinchu branch ( Site 3907)
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 3912)
city: Kaohsiung
country: Taiwan
facility: E-Da hospital ( Site 3911)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 3909)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital-Oncology ( Site 3904)
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital-Chest Medicine ( Site 3902)
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital ( Site 3900)
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital ( Site 4003)
state: Chiang Mai
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital ( Site 4000)
state: Krung Thep Maha Nakhon
city: Muang
country: Thailand
facility: Lampang Cancer Hospital ( Site 4005)
state: Lampang
city: HatYai
country: Thailand
facility: Songklanagarind hospital ( Site 4001)
state: Songkhla
city: Khon Kaen
country: Thailand
facility: Faculty of Medicine - Khon Kaen University ( Site 4004)
city: Ubon Ratchathani
country: Thailand
facility: Sunpasitthiprasong Hospital-Oncology ( Site 4002)
city: Stanbul
country: Turkey
facility: Medipol Mega Universite Hastanesi-oncology ( Site 2505)
state: Istanbul
city: Bornova
country: Turkey
facility: Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2504)
state: Izmir
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500)
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2501)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502)
city: London
country: United Kingdom
facility: ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2606)
state: Kensington And Chelsea
city: London
country: United Kingdom
facility: St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2600)
state: London, City Of
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 2603)
state: London, City Of
city: Sutton.
country: United Kingdom
facility: Royal Marsden Hospital (Sutton) ( Site 2605)
state: Surrey
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust ( Site 2604)
city: Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre ( Site 2602)
city: Hanoi
country: Vietnam
facility: Hanoi Oncology Hospital ( Site 4102)
state: Ha Noi
city: Hanoi
country: Vietnam
facility: K Hospital - National Cancer Hospital ( Site 4105)
state: Ha Noi
city: Hanoi
country: Vietnam
facility: National Lung Hospital-Oncology Department ( Site 4104)
state: Ha Noi
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: