Clinical trial NCT04738487: Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)
Official title: A Phase 3, Multicenter, Randomized, Double-Blind Study of MK-7684 With Pembrolizumab as a Coformulation (MK-7684A) Versus Pembrolizumab Monotherapy as First Line Treatment for Participants With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Lung Neoplasms
Non-Small-Cell Lung Carcinoma
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2021-02-04
Enrollment: 1264
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: Researchers are looking for new ways to treat people with metastatic non-small cell lung cancer (NSCLC) that is PD-L1 positive.

* Metastatic means cancer that has spread to other parts of the body.
* PD-L1 positive means that PD-L1 is found on the cancer cells. PD-L1 is a protein that can help the cancer hide from the body's immune system.

The goal of this study is to learn if people who receive vibostolimab and pembrolizumab live longer overall and without the cancer getting worse than people who receive pembrolizumab alone.


Eligibility criteria: Inclusion Criteria:

* Has a histologically or cytologically confirmed diagnosis of Stage IV: M1a, M1b, or M1c non-small cell lung cancer (NSCLC) per the American Joint Committee on Cancer (AJCC) Staging Manual, version 8
* Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the local site assessment
* Has confirmation that epidermal growth factor receptor (EGFR)-, anaplastic lymphoma kinase (ALK)-, or reactive oxygen species proto-oncogene 1 (ROS1)-directed therapy is not indicated as primary therapy and absence of ALK and ROS1 gene rearrangements
* Has provided tumor tissue that demonstrates Programmed Cell Death 1 Ligand 1 (PD-L1) expression in ≥1% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
* Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 assessed within 7 days prior to randomization
* Has a life expectancy of at least 3 months
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

  * Is not a woman of childbearing potential (WOCBP)
  * Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days after the last dose of study intervention
* Has adequate organ function

Exclusion Criteria:

* Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy
* Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC.

  * Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 6 months before the diagnosis of metastatic NSCLC.
  * Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.
* Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137)
* Has received previous treatment with another agent targeting the T cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibition motif (ITIM) domains (TIGIT) receptor pathway
* Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
* Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines is allowed.

  * Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed in the study as long as they are mRNA vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy.
  * Investigational vaccines (i.e., those not licensed or approved for Emergency Use) are not allowed.
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
* Has known active or untreated CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks by repeat imaging, clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention
* Has severe hypersensitivity (≥Grade 3) to pembrolizumab/vibostolimab or pembrolizumab and/or any of its excipients
* Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
* 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 to the first dose of study intervention
* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
* Has a known history of interstitial lung disease. Lymphangitic spread of the NSCLC is not exclusionary.
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority
* Has a known history of Hepatitis B or known active Hepatitis C virus infection
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that prevents the participant from receiving platinum-doublet chemotherapy for first line NSCLC, or that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study

Primary outcomes:
measure: Overall Survival (OS) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50%
timeFrame: Up to ~68 months
Secondary outcomes:
measure: OS in Participants With PD-L1 TPS ≥1%
timeFrame: Up to ~68 months
measure: OS in Participants With PD-L1 TPS 1% to 49%
timeFrame: Up to ~68 months
measure: Progression-Free Survival (PFS) in Participants With PD-L1 TPS ≥1%
timeFrame: Up to ~54 months
measure: PFS in Participants With PD-L1 TPS ≥50%
timeFrame: Up to ~54 months
measure: PFS in Participants With PD-L1 TPS 1% to 49%
timeFrame: Up to ~54 months
measure: Objective Response Rate (ORR) in Participants With PD-L1 TPS ≥1%
timeFrame: Up to ~54 months
measure: ORR in Participants With PD-L1 TPS ≥50%
timeFrame: Up to ~54 months
measure: ORR in Participants With PD-L1 TPS 1% to 49%
timeFrame: Up to ~54 months
measure: Duration of Response (DOR) in Participants With PD-L1 TPS ≥50%
timeFrame: Up to ~54 months
measure: DOR in Participants With PD-L1 TPS 1% to 49%
timeFrame: Up to ~54 months
measure: DOR in Participants With PD-L1 TPS ≥1%
timeFrame: Up to ~54 months
measure: Change from Baseline in Global Health Status/Quality of Life (QoL) (Items 29, 30) Combined Score on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30) in Participants With PD-L1 TPS ≥50%
timeFrame: Baseline and up to ~109 weeks
measure: Change from Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
timeFrame: Baseline and up to ~109 weeks
measure: Change from Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
timeFrame: Baseline and up to ~109 weeks
measure: Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
timeFrame: Baseline and up to ~109 weeks
measure: Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
timeFrame: Baseline and up to ~109 weeks
measure: Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
timeFrame: Baseline and up to ~109 weeks
measure: Change from Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
timeFrame: Baseline and up to ~109 weeks
measure: Change from Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
timeFrame: Baseline and up to ~109 weeks
measure: Change from Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
timeFrame: Baseline and up to ~109 weeks
measure: Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
timeFrame: Baseline and up to ~109 weeks
measure: Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
timeFrame: Baseline and up to ~109 weeks
measure: Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
timeFrame: Baseline and up to ~109 weeks
measure: Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) in Participants With PD-L1 TPS ≥50%
timeFrame: Baseline and up to ~109 weeks
measure: Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49%
timeFrame: Baseline and up to ~109 weeks
measure: Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1%
timeFrame: Baseline and up to ~109 weeks
measure: Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50%
timeFrame: Baseline and up to ~109 weeks
measure: Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49%
timeFrame: Baseline and up to ~109 weeks
measure: Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1%
timeFrame: Baseline and up to ~109 weeks
measure: Time to Deterioration (TTD) in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
timeFrame: Baseline and up to ~109 weeks
measure: TTD in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
timeFrame: Baseline and up to ~109 weeks
measure: TTD in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
timeFrame: Baseline and up to ~109 weeks
measure: TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
timeFrame: Baseline and up to ~109 weeks
measure: TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% to 49%
timeFrame: Baseline and up to ~109 weeks
measure: TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
timeFrame: Baseline and up to ~109 weeks
measure: TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
timeFrame: Baseline and up to ~109 weeks
measure: TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
timeFrame: Baseline and up to ~109 weeks
measure: TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
timeFrame: Baseline and up to ~109 weeks
measure: TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50%
timeFrame: Baseline and up to ~109 weeks
measure: TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49%
timeFrame: Baseline and up to ~109 weeks
measure: TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1%
timeFrame: Baseline and up to ~109 weeks
measure: TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50%
timeFrame: Baseline and up to ~109 weeks
measure: TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49%
timeFrame: Baseline and up to ~109 weeks
measure: TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1%
timeFrame: Baseline and up to ~109 weeks
measure: TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50%
timeFrame: Baseline and up to ~109 weeks
measure: TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49%
timeFrame: Baseline and up to ~109 weeks
measure: TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1%
timeFrame: Baseline and up to ~109 weeks
measure: Number of Participants Who Experienced One or More Adverse Events (AEs)
timeFrame: Up to ~117 weeks
measure: Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
timeFrame: Up to ~105 weeks
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital ( Site 0004)
state: Florida
city: Peoria
country: United States
facility: Illinois Cancer Care ( Site 0026)
state: Illinois
city: Saint Louis
country: United States
facility: Mercy Research - David C. Pratt Cancer Center ( Site 0025)
state: Missouri
city: Springfield
country: United States
facility: Mercy Research - Cancer and Hematology Center ( Site 0032)
state: Missouri
city: Mineola
country: United States
facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0022)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center ( Site 0013)
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center-Hematology/Oncology ( Site 0030)
state: Pennsylvania
city: Fortaleza
country: Brazil
facility: Hospital São Carlos-Oncocentro Ce ( Site 0208)
state: Ceara
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0201)
state: Rio Grande Do Norte
city: Ijui
country: Brazil
facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro de Pesquisa Novos Tratamentos em Cân
state: Rio Grande Do Sul
city: Florianópolis
country: Brazil
facility: CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0209)
state: Santa Catarina
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0204)
city: Sao Paulo
country: Brazil
facility: ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0200)
city: Sao Paulo
country: Brazil
facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0207)
city: Victoria
country: Canada
facility: BC Cancer Victoria-Clinical Trials Unit ( Site 0107)
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0104)
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0102)
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health ( Site 0106)
state: Ontario
city: Laval
country: Canada
facility: Centre Intégré de Santé et de Services Sociaux (CISSS) de La-Centre intégré de cancérologie de Lava
state: Quebec
city: Temuco
country: Chile
facility: James Lind Centro de Investigacion del Cancer ( Site 0711)
state: Araucania
city: Temuco
country: Chile
facility: CIDO SpA-Oncology ( Site 0707)
state: Araucania
city: La Serena
country: Chile
facility: IC La Serena Research ( Site 0710)
state: Coquimbo
city: Puerto Montt
country: Chile
facility: Clínica Puerto Montt ( Site 0713)
state: Los Lagos
city: Valdivia
country: Chile
facility: Oncocentro Valdivia ( Site 0715)
state: Los Rios
city: Talca
country: Chile
facility: Clinica Universidad Catolica del Maule-Oncology ( Site 0703)
state: Maule
city: Santiago
country: Chile
facility: Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0712)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Orlandi Oncologia ( Site 0700)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: FALP ( Site 0702)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill ( Site 0701)
state: Region M. De Santiago
city: Antofagasta
country: Chile
facility: Bradford Hill Norte ( Site 0708)
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University ( Site 2022)
state: Anhui
city: Hefei
country: China
facility: Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2017)
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science-Oncology ( Site 2030)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer hospital-intrathoratic deparmtment II ( Site 2001)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2003)
state: Beijing
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital-pneumology department ( Site 2009)
state: Beijing
city: Beijing
country: China
facility: Beijing Chest Hospital,Capital Medical University ( Site 2020)
state: Beijing
city: Chongqing
country: China
facility: Chongqing Cancer Hospital-Medical Oncology ( Site 2028)
state: Chongqing
city: Chongqing
country: China
facility: Army Medical Center of People's Liberation Army-respiratory ( Site 2025)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital-oncology department ( Site 2023)
state: Fujian
city: Fuzhou
country: China
facility: Fuzhou General hospital of Nanjing Military Command-Oncology Department ( Site 2029)
state: Fujian
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital ( Site 2006)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 2015)
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital-Medical Oncology ( Site 2019)
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University-Respiratory -Asthma&COPD ( Site 2026)
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital-thoracic oncology II ( Site 2013)
state: Hunan
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital-General Surgery Department ( Site 2016)
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital-oncology department ( Site 2000)
state: Jilin
city: Xi'an
country: China
facility: Tang Du Hospital ( Site 2004)
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University wa-Oncology ( Site 2012)
state: Shaanxi
city: Linyi
country: China
facility: LinYi Cancer Hospital ( Site 2034)
state: Shandong
city: Linyi
country: China
facility: Linyi People's Hospital-Oncology ( Site 2035)
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center ( Site 2032)
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital Sichuan University-respiratory ( Site 2018)
state: Sichuan
city: Hangzhou
country: China
facility: Hangzhou Cancer Hospital-Medical Oncology ( Site 2039)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital-Breast Oncology ( Site 2008)
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site
state: Zhejiang
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province-Respiratory ( Site 2027)
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 2031)
state: Zhejiang
city: Santo Domingo
country: Dominican Republic
facility: Instituto de Oncologia ( Site 2300)
state: Distrito Nacional
city: Santo Domingo
country: Dominican Republic
facility: CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 2301)
state: Distrito Nacional
city: Guatemala City
country: Guatemala
facility: Onco Go, S.A ( Site 0306)
city: Guatemala
country: Guatemala
facility: CELAN,S.A ( Site 0304)
city: Guatemala
country: Guatemala
facility: Gastrosoluciones ( Site 0302)
city: Guatemala
country: Guatemala
facility: INTEGRA Cancer Institute ( Site 0303)
city: Guatemala
country: Guatemala
facility: Oncomedica-Guatemala ( Site 0301)
city: Guatemala
country: Guatemala
facility: Grupo Medico Angeles ( Site 3007)
city: Central
country: Hong Kong
facility: Hong Kong Integrated Oncology Centre ( Site 1301)
city: Hksar
country: Hong Kong
facility: Queen Mary Hospital ( Site 1303)
city: Jordan
country: Hong Kong
facility: Hong Kong United Oncology Centre ( Site 1302)
city: Lai Chi Kok
country: Hong Kong
facility: Princess Margaret Hospital ( Site 1304)
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1201)
state: Bacs-Kiskun
city: Gyula
country: Hungary
facility: Békés Megyei Központi Kórház Pándy Kálmán Tagkórház-Megyei Onkológiai Centrum ( Site 1207)
state: Bekes
city: Gyor
country: Hungary
facility: Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia ( Site 1205)
state: Gyor-Moson-Sopron
city: Kékestető
country: Hungary
facility: Mátrai Gyógyintézet ( Site 1214)
state: Heves
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 1200)
state: Jasz-Nagykun-Szolnok
city: Budapest
country: Hungary
facility: Országos Korányi Pulmonológiai Intézet-XIV. Tüdöbelgyógyászat ( Site 1204)
state: Pest
city: Torokbalint
country: Hungary
facility: Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1208)
state: Pest
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Kórház-Pulmonológia ( Site 1202)
state: Zala
city: Budapest
country: Hungary
facility: Semmelweis University-Pulmonológiai Klinika ( Site 1209)
city: New Delhi
country: India
facility: All India Institute of Medical Sciences ( Site 2403)
state: Delhi
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute And Research Centre ( Site 2400)
state: Delhi
city: Gurugram
country: India
facility: Artemis hospital ( Site 2401)
state: Haryana
city: Mumbai
country: India
facility: Tata Memorial Hospital-Medical Oncology ( Site 2404)
state: Maharashtra
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center ( Site 1920)
state: Aichi
city: Toyoake
country: Japan
facility: Fujita Health University ( Site 1906)
state: Aichi
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 1911)
state: Ehime
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 1912)
state: Fukuoka
city: Otashi
country: Japan
facility: Gunma Prefectural Cancer Center ( Site 1925)
state: Gunma
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center ( Site 1923)
state: Hokkaido
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine-Respiratory Medicine and Hematology ( Site 1922)
state: Hyogo
city: Takarazuka
country: Japan
facility: Takarazuka City Hospital ( Site 1924)
state: Hyogo
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center ( Site 1921)
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa cancer center ( Site 1916)
state: Kanagawa
city: Sendai
country: Japan
facility: Sendai Kousei Hospital ( Site 1900)
state: Miyagi
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital ( Site 1904)
state: Niigata
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 1914)
state: Osaka
city: Osaka-sayama
country: Japan
facility: Kindai University Hospital- Osakasayama Campus ( Site 1907)
state: Osaka
city: Sakai
country: Japan
facility: National Hospital Organization Kinki-chuo Chest Medical Center-Department of Thoracic Oncology ( Sit
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital ( Site 1908)
state: Osaka
city: Nagaizumi
country: Japan
facility: Shizuoka Cancer Center ( Site 1905)
state: Shizuoka
city: Utsunomiya
country: Japan
facility: Tochigi Cancer Center ( Site 1927)
state: Tochigi
city: Chiba
country: Japan
facility: Chiba University Hospital-Medical Oncology ( Site 1926)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 1913)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 1915)
city: Tokushima
country: Japan
facility: Tokushima University Hospital ( Site 1917)
city: Tokyo
country: Japan
facility: Juntendo University Hospital ( Site 1902)
city: Tokyo
country: Japan
facility: Japanese Foundation for Cancer Research ( Site 1901)
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital ( Site 1910)
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital-Internal medicine ( Site 1406)
state: Chungbuk
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center-Lung Cancer Center ( Site 1407)
state: Kyonggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 1403)
state: Kyonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 1405)
state: Kyonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 1401)
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital ( Site 1409)
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital-Cancer center ( Site 1410)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System ( Site 1402)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 1400)
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital-Medical Oncology ( Site 1408)
city: Lembah Pantai
country: Malaysia
facility: University Malaya Medical Centre ( Site 1504)
state: Kuala Lumpur
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan ( Site 1502)
state: Pahang
city: George Town
country: Malaysia
facility: Gleneagles Penang Medical Center-Clinical Research Center (CRC) ( Site 1503)
state: Pulau Pinang
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang ( Site 1501)
state: Pulau Pinang
city: Putrajaya
country: Malaysia
facility: National Cancer Institute ( Site 1505)
state: Wilayah Persekutuan Putrajaya
city: Mexico
country: Mexico
facility: Arké SMO S.A. de C.V. ( Site 0417)
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0411)
state: Jalisco
city: Morelia
country: Mexico
facility: Centro de Investigacion Clinica Chapultepec ( Site 0400)
state: Michoacan
city: Monterrey
country: Mexico
facility: iCan Oncology Center Centro Medico AVE ( Site 0405)
state: Nuevo Leon
city: Santiago de Queretaro
country: Mexico
facility: Hospital H+ Queretaro ( Site 0416)
state: Queretaro
city: Merida
country: Mexico
facility: Medical Care and Research SA de CV ( Site 0409)
state: Yucatan
city: Chihuahua
country: Mexico
facility: Centro Oncologico de Chihuahua-Unidad de Investigacion Clinica ( Site 0402)
city: Mexico city
country: Mexico
facility: Human Science Research Trials ( Site 0406)
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization ( Site 0403)
city: San isidro
country: Peru
facility: IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0507)
state: Lima
city: Cusco
country: Peru
facility: UNIDAD DE ONCOLOGIA HOSPITAL NACIONAL ADOLFO GUEVARA VELASCO ESSSALUD CUSCO ( Site 0504)
state: Qusqu
city: Lima
country: Peru
facility: Hospital Guillermo Almenara Irigoyen-Oncology ( Site 0508)
city: Lima
country: Peru
facility: Clínica Internacional - Sede San Borja ( Site 0506)
city: Lima
country: Peru
facility: INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0500)
city: Lima
country: Peru
facility: Hospital Militar Central Luis Arias Schereiber ( Site 0502)
city: Quezon City
country: Philippines
facility: East Avenue Medical Center-Department of Medicine ( Site 1605)
state: National Capital Region
city: Quezon City
country: Philippines
facility: Veterans Memorial Medical Center-Section of Oncology ( Site 1608)
state: National Capital Region
city: San Juan City, Metro Manila
country: Philippines
facility: CARDINAL SANTOS MEDICAL CENTER ( Site 1606)
state: National Capital Region
city: Cluj-Napoca
country: Romania
facility: Cardiomed SRL Cluj-Napoca ( Site 2201)
state: Cluj
city: Craiova
country: Romania
facility: Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2202)
state: Dolj
city: Ploiesti
country: Romania
facility: SC Medical Center Gral SRL ( Site 2203)
state: Prahova
city: Balashikha
country: Russian Federation
facility: Moscow Regional Oncological Dispensary ( Site 0812)
state: Moskovskaya Oblast
city: Moscow
country: Russian Federation
facility: Hadassah Medical-Oncology department ( Site 0814)
state: Moskovskaya Oblast
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of the Presidential Administrative Department ( Site 0802)
state: Moskva
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 0809)
state: Nizhegorodskaya Oblast
city: Saint-Petersburg
country: Russian Federation
facility: GBUZ LOKB-Oncology department #1 ( Site 0804)
state: Sankt-Peterburg
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary ( Site 0805)
state: Tatarstan, Respublika
city: Sankt-Peterburg
country: Russian Federation
facility: Scientific research institution of oncology named after N.N. Petrov-Thoracic oncology ( Site 0803)
city: Johannesburg
country: South Africa
facility: Wits Clinical Research ( Site 0900)
state: Gauteng
city: Johannesburg
country: South Africa
facility: Medical Oncology Centre of Rosebank ( Site 0906)
state: Gauteng
city: Pretoria
country: South Africa
facility: LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0901)
state: Gauteng
city: Sandton
country: South Africa
facility: Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0902)
state: Gauteng
city: Soweto
country: South Africa
facility: Wits Clinical Research-Wits Clinical Research Bara ( Site 0908)
state: Gauteng
city: Durban
country: South Africa
facility: The Oncology Centre ( Site 0905)
state: Kwazulu-Natal
city: Richards Bay
country: South Africa
facility: Abraham Oncology ( Site 0907)
state: Kwazulu-Natal
city: Cape Town
country: South Africa
facility: Cape Town Oncology Trials ( Site 0903)
state: Western Cape
city: Bangkok
country: Thailand
facility: Chulalongkorn University ( Site 1802)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Ramathibodi Clinical Research Centre ( Site 1801)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital ( Site 1800)
state: Krung Thep Maha Nakhon
city: Talas
country: Turkey
facility: Erciyes University Medical Oncology Department ( Site 1007)
state: Kayseri
city: Ankara
country: Turkey
facility: Hacettepe Universitesi-oncology hospital ( Site 1001)
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi-Medical Oncology ( Site 1002)
city: Ankara
country: Turkey
facility: Gazi Universitesi-Oncology ( Site 1003)
city: İstanbul
country: Turkey
facility: Acıbadem Maslak Hastanesi ( Site 1008)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1000)
city: Samsun
country: Turkey
facility: Samsun Medical Park Hastanesi-medical oncology ( Site 1005)
city: Cherkassy
country: Ukraine
facility: Cherkasy Regional Oncology Dispensary ( Site 1110)
state: Cherkaska Oblast
city: Chernihiv
country: Ukraine
facility: Chernihiv Medical Center of Modern Oncology-Clinical oncology and gynecology department ( Site 1113)
state: Chernihivska Oblast
city: Dnipro
country: Ukraine
facility: Municipal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council ( Site 1100)
state: Dnipropetrovska Oblast
city: Kryvyi Rih
country: Ukraine
facility: MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional-Chemotherapy department ( Site 1104)
state: Dnipropetrovska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regio
state: Ivano-Frankivska Oblast
city: Kharkiv
country: Ukraine
facility: Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1119)
state: Kharkivska Oblast
city: Kyiv
country: Ukraine
facility: National Cancer Institute ( Site 1114)
state: Kyivska Oblast
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Oncological Hospital ( Site 1102)
state: Vinnytska Oblast
city: Uzhhorod
country: Ukraine
facility: Uzhgorod Central City Clinical Hospital-City oncology center ( Site 1120)
state: Zakarpatska Oblast
city: Zaporizhzhia
country: Ukraine
facility: Oncolife LLC-day-stay department ( Site 1107)
state: Zaporizka Oblast
city: Zhytomyr
country: Ukraine
facility: Zhytomyr Regional Oncology Center-Chemotherapy Department ( Site 1103)
state: Zhytomyrska Oblast
city: Hanoi
country: Vietnam
facility: Hanoi Oncology Hospital ( Site 2502)
state: Ha Noi
city: Hanoi
country: Vietnam
facility: K Hospital - National Cancer Hospital ( Site 2506)
state: Ha Noi
city: Hanoi
country: Vietnam
facility: National Lung Hospital-Oncology Department ( Site 2503)
state: Ha Noi
city: Ho Chi Minh
country: Vietnam
facility: Ho Chi Minh City Oncology Hospital - Tan Phu Ward ( Site 2505)
city: Ho Chi Minh
country: Vietnam
facility: HCMC University Medical Center-Chemotherapy Department ( Site 2501)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: