A Study of MK-1084 Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant, Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004)
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT06345729
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This is a study evaluating the efficacy and safety of MK-1084 with pembrolizumab as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two primary study hypotheses:
Hypothesis 1: Combination of MK-1084 and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Hypothesis 2: Combination of MK-1084 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- Has a histologically or cytologically confirmed diagnosis of NSCLC
- Has newly diagnosed Stage IV NSCLC by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8
- Has measurable disease based on RECIST 1.1
- Has provided tumor tissue that demonstrates PD-L1 expression in ≥50% of tumor cells
- Has provided tumor tissue that demonstrates presence of KRAS G12C mutation
- Has life expectancy of at least 3 months
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization
- For participant assigned male sex at birth: If capable of producing sperm, participant must agree to the following during the study treatment period and for at least 10 days after the last dose of oral intervention: Either be abstinent or must agree to use male condom plus additional contraceptive method.
- For participant assigned female sex at birth: Either be a person of nonchildbearing potential (PONCBP) or must agree to follow contraceptive guidance during the study treatment period and for at least 10 days after the last dose of oral intervention and 120 days after the last dose of pembrolizumab. Must abstain from breastfeeding during the study intervention period and for at least 120 days after study intervention.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
- Diagnosis of small cell lung cancer
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
- Has a known history of, or active, neurologic paraneoplastic syndrome
- Has an active infection requiring systemic therapy
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QT interval corrected for heart rate by Fridericia's formula (QTcF) interval to >470 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention
- Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease. Examples include, but are not limited to, uncontrolled major seizure disorder, unstable spinal cord compression, or superior vena cava syndrome.
- Has one or more of the following ophthalmological findings/conditions: intraocular diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion, diagnosis of retinal degenerative disease pressure >21 mm Hg and/or any diagnosis of glaucoma
- Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (eg, gastrectomy, partial bowel obstruction, or malabsorption)
- Received prior systemic anticancer therapy for their metastatic NSCLC
- Received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor within 12 months before diagnosis of metastatic NSCLC
- Has received radiotherapy within 2 weeks of start of study intervention
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- 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
- Active autoimmune disease that has required systemic treatment in the past 2 years
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- History of allogeneic tissue/solid organ transplant
- Has not fully recovered from any effects of major surgical procedure. Surgical procedures that required general anesthesia must be completed at least 2 weeks before first study intervention administration.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MK-1084 with Pembrolizumab MK-1084 Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and MK-1084 by oral tablets once daily until discontinuation criterion is met. Placebo with Pembrolizumab Placebo Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and placebo by oral tablets once daily until discontinuation criterion is met. MK-1084 with Pembrolizumab Pembrolizumab Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and MK-1084 by oral tablets once daily until discontinuation criterion is met. Placebo with Pembrolizumab Pembrolizumab Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and placebo by oral tablets once daily until discontinuation criterion is met.
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Up to approximately 42 months PFS is defined as the time from randomization until either documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. PFS as determined by blinded independent central review (BICR) will be presented.
Overall Survival (OS) Up to approximately 56 months OS is defined as the time from randomization to death due to any cause.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Experience One or More Adverse Event (AEs) Up to approximately 56 months An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experience an AE will be presented.
Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score Baseline and Up to approximately 24 months TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in dyspnea (EORTC QLQ-C30 Item 8) score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. 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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in dyspnea score, will be presented. A longer TTD indicates a better outcome.
Duration of Response (DOR) Up to approximately 42 months For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, duration of response 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 from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score Baseline and Up to approximately 24 months The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. 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). The change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. A higher score indicates a worse level of dyspnea.
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score Baseline and Up to approximately 24 months The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. Higher scores indicate a better level of functioning.
Objective Response Rate (ORR) Up to approximately 42 months ORR is defined as the percentage of participants with Complete Response or Partial Response per RECIST1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) Up to approximately 56 months An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinue study treatment due to an AE will be presented.
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score Baseline and Up to approximately 24 months The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. Higher scores indicate a better level of functioning.
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score Baseline and Up to approximately 24 months The EORTC QLQ-C30 is a questionnaire to assess the overall 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. The change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. Higher scores indicate a better overall health status.
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score Baseline and Up to approximately 24 months The EORTC QLQ-C13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C13 Item 31 will be presented. A higher score indicates more frequent coughing.
Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score Baseline and Up to approximately 24 months TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in physical functioning (EORTC QLQ-C30 Items 1-5) score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning 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 TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome.
Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Chest pain (Item 40) Score Baseline and Up to approximately 24 months TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in chest pain (EORTC QLQ-C13 Item 40) score. The EORTC QLQ-C13 is lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question "Have you had pain in your chest?" is 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 TTD, as assessed based on a ≥10 point negative change (decrease) from baseline chest pain score, will be presented. A longer TTD indicates a better outcome.
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) Chest pain (Item 40) Score Baseline and Up to approximately 24 months The EORTC QLQ-C13 is lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C13 Item 40 will be presented. A higher score indicates a worse level of chest pain.
Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score Baseline and Up to approximately 24 months TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in global health status (GHS) and quality of life (QoL) (EORTC QLQ-C30 Items 29 and 30) score. 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. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in GHS and QoL, will be presented. A longer TTD indicates a better outcome.
Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score Baseline and Up to approximately 24 months TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in role functioning (EORTC QLQ-C30 Items 6 and 7) score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 2 questions about their role functioning 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 TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in role functioning score, will be presented. A longer TTD indicates a better outcome.
Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score Baseline and Up to approximately 24 months TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in cough (EORTC QLQ-C13 Item 31) score. The EORTC QLQ-C13 is lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question "Have you coughed?" is 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 TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in cough score, will be presented. A longer TTD indicates a better outcome.
Trial Locations
- Locations (172)
CBCC Global Research, Inc. ( Site 0123)
🇺🇸Bakersfield, California, United States
Beverly Hills Cancer Center ( Site 0116)
🇺🇸Beverly Hills, California, United States
Mount Sinai Cancer Center ( Site 0137)
🇺🇸Miami Beach, Florida, United States
Orchard Healthcare Research Inc. ( Site 0115)
🇺🇸Skokie, Illinois, United States
Cox Medical Center North ( Site 0133)
🇺🇸Springfield, Missouri, United States
St. Vincent Frontier Cancer Center-Research ( Site 0105)
🇺🇸Billings, Montana, United States
Atlantic Health System Morristown Medical Center ( Site 0121)
🇺🇸Morristown, New Jersey, United States
New York Oncology Hematology, P.C. ( Site 0132)
🇺🇸Albany, New York, United States
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103)
🇺🇸Cincinnati, Ohio, United States
Kettering Health Main Campus-Kettering Health Cancer Center ( Site 0106)
🇺🇸Kettering, Ohio, United States
Oncology Consultants P.A. ( Site 0113)
🇺🇸Houston, Texas, United States
Circuit Clinical/SSM Health Dean Medical Group ( Site 0129)
🇺🇸Madison, Wisconsin, United States
AUSTRAL MEDICAL CENTER ( Site 0302)
🇦🇷Caba, Buenos Aires, Argentina
Centro Oncologico Korben ( Site 0304)
🇦🇷Caba, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)
🇦🇷Mar del Plata, Buenos Aires, Argentina
Fundacion Estudios Clinicos ( Site 0306)
🇦🇷Rosario, Santa Fe, Argentina
Sanatorio Parque ( Site 0301)
🇦🇷Rosario, Santa Fe, Argentina
Chris O'Brien Lifehouse ( Site 3000)
🇦🇺Camperdown, New South Wales, Australia
Frankston Hospital ( Site 3002)
🇦🇺Frankston, Victoria, Australia
One Clinical Research ( Site 3001)
🇦🇺Nedlands, Western Australia, Australia
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 2401)
🇦🇹Graz, Steiermark, Austria
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 2400)
🇦🇹Wien, Austria
Hospital Mario Penna ( Site 0436)
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Hospital de Câncer de Recife ( Site 0447)
🇧🇷Recife, Pernambuco, Brazil
Oncoclínica Oncologistas Associados ( Site 0441)
🇧🇷Terezina, Piaui, Brazil
Liga Norte Riograndense Contra o Câncer ( Site 0439)
🇧🇷Natal., Rio Grande Do Norte, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro Multidisciplinar de Pesquisa Clínica ( Site 0435)
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0437)
🇧🇷Barretos., Sao Paulo, Brazil
Instituto Nacional de Câncer - INCA ( Site 0446)
🇧🇷Rio de Janeiro, Brazil
Americas ( Site 0431)
🇧🇷Rio de Janeiro, Brazil
MBAL Uni Hospital-Department of Medical Oncology ( Site 1000)
🇧🇬Panagyurishte, Pazardzhik, Bulgaria
MHAT - Heart and Brain ( Site 1006)
🇧🇬Pleven, Bulgaria
CancerCare Manitoba ( Site 0210)
🇨🇦Winnipeg, Manitoba, Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0205)
🇨🇦Hamilton, Ontario, Canada
Sunnybrook Research Institute ( Site 0206)
🇨🇦Toronto, Ontario, Canada
St. Marys Hospital Center ( Site 0204)
🇨🇦Montreal, Quebec, Canada
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0207)
🇨🇦Trois-Rivières, Quebec, Canada
Clinica Universidad Catolica del Maule-Oncology ( Site 0500)
🇨🇱Talca, Maule, Chile
Orlandi Oncologia-Oncology ( Site 0503)
🇨🇱Santiago, Region M. De Santiago, Chile
FALP-UIDO ( Site 0501)
🇨🇱Santiago, Region M. De Santiago, Chile
Centro de Oncología de Precisión-Oncology ( Site 0502)
🇨🇱Santiago, Region M. De Santiago, Chile
Bradfordhill-Clinical Area ( Site 0504)
🇨🇱Santiago, Region M. De Santiago, Chile
Anhui Provincial Cancer Hospital ( Site 3136)
🇨🇳Hefei, Anhui, China
Beijing Cancer hospital ( Site 3133)
🇨🇳Beijing, Beijing, China
Beijing Cancer hospital ( Site 3134)
🇨🇳Beijing, Beijing, China
Beijing Peking Union Medical College Hospital-pneumology department ( Site 3102)
🇨🇳Beijing, Beijing, China
Beijing Chest Hospital,Capital Medical University ( Site 3104)
🇨🇳Beijing, Beijing, China
Chongqing University Cancer Hospital ( Site 3119)
🇨🇳Chongqing, Chongqing, China
Army Medical Center of People's Liberation Army ( Site 3142)
🇨🇳Chongqing, Chongqing, China
Fujian Cancer Hospital ( Site 3127)
🇨🇳Fuzhou, Fujian, China
The First Affiliated hospital of Xiamen University ( Site 3148)
🇨🇳Xiamen, Fujian, China
The First Affiliated Hospital of Guangzhou Medical University ( Site 3108)
🇨🇳Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital ( Site 3128)
🇨🇳Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center ( Site 3137)
🇨🇳Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital ( Site 3123)
🇨🇳Harbin, Heilongjiang, China
JIAMUSI TUBERCULOSIS HOSPITAL(CANCER HOSPITAL) ( Site 3124)
🇨🇳Jiamusi, Heilongjiang, China
Henan Cancer Hospital ( Site 3149)
🇨🇳Zhengzhou, Henan, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 3113)
🇨🇳Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 3126)
🇨🇳Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University ( Site 3130)
🇨🇳Changsha, Hunan, China
Hunan Cancer Hospital ( Site 3141)
🇨🇳Changsha, Hunan, China
Nanjing Gulou Hospital ( Site 3122)
🇨🇳Nanjing, Jiangsu, China
Nanjing First Hospital ( Site 3154)
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University ( Site 3146)
🇨🇳Suzhou, Jiangsu, China
Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3155)
🇨🇳Wuxi City, Jiangsu, China
The Second Affiliated Hospital of Nanchang University ( Site 3139)
🇨🇳Nanchang, Jiangxi, China
The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 3138)
🇨🇳Nanchang, Jiangxi, China
Jilin Province Tumor Hospital ( Site 3107)
🇨🇳Changchun, Jilin, China
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 3150)
🇨🇳Xian, Shaanxi, China
Shandong Cancer Hospital ( Site 3116)
🇨🇳Jinan, Shandong, China
LinYi Cancer Hospital ( Site 3111)
🇨🇳Linyi, Shandong, China
Shanghai Chest Hospital ( Site 3100)
🇨🇳Shanghai, Shanghai, China
Fudan University Shanghai Cancer Center ( Site 3144)
🇨🇳Shanghai, Shanghai, China
Zhongshan Hospital,Fudan University ( Site 3143)
🇨🇳Shanghai, Shanghai, China
Shanxi Cancer Hospital ( Site 3131)
🇨🇳Taiyuan, Shanxi, China
The Second Affiliated Hospital of Air Force Medical University ( Site 3117)
🇨🇳Xian, Shanxi, China
The Second Affiliated Hospital of Air Force Medical University ( Site 3152)
🇨🇳Xian, Shanxi, China
West China Hospital, Sichuan University ( Site 3140)
🇨🇳Cheng Du, Sichuan, China
The Third People's Hospital of Chengdu (CDTPH) ( Site 3157)
🇨🇳Chengdu, Sichuan, China
Sichuan Cancer hospital. ( Site 3109)
🇨🇳Chengdu, Sichuan, China
The Second People's Hospital of Neijiang ( Site 3105)
🇨🇳Neijiang, Sichuan, China
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 3101)
🇨🇳Urumqi, Xinjiang, China
Yunnan Province Cancer Hospital ( Site 3153)
🇨🇳Kunming, Yunnan, China
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 3115)
🇨🇳Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 3121)
🇨🇳Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province ( Site 3145)
🇨🇳Linhai, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University ( Site 3151)
🇨🇳Wenzhou, Zhejiang, China
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1103)
🇫🇷Dijon, Bourgogne, France
Hôpital Ambroise Paré-Department of Respiratory Diseases and Thoracic Oncology ( Site 1105)
🇫🇷Boulogne-Billancourt, Ile-de-France, France
Clinique Teissier Groupe ( Site 1100)
🇫🇷Valenciennes, Nord, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 1101)
🇫🇷Clermont-Ferrand, Puy-de-Dome, France
Centre Hospitalier d'Avignon-Service d'Oncologie médicale et d'hématologie clinique ( Site 1104)
🇫🇷Avignon, Vaucluse, France
High Technology Hospital Medcenter ( Site 1203)
🇬🇪Batumi, Ajaria, Georgia
American Hospital Network LLC ( Site 1208)
🇬🇪Tbilisi, Georgia
Todua Clinic, LLC ( Site 1204)
🇬🇪Tbilisi, Georgia
TSMU and Ingorokva High Medical Technology University Clinic LTD ( Site 1201)
🇬🇪Tbilisi, Georgia
New Hospitals ( Site 1200)
🇬🇪Tbilisi, Georgia
Cancer Research Centre. Mardaleishvili Medical Centre ( Site 1205)
🇬🇪Tbilisi, Georgia
Caucasus Medical Centre ( Site 1202)
🇬🇪Tbilisi, Georgia
Tbilisi Institute of Medicine ( Site 1206)
🇬🇪Tbilisi, Georgia
Krankenhaus Bethanien ( Site 1303)
🇩🇪Solingen, Nordrhein-Westfalen, Germany
UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1402)
🇬🇷Patras, Achaia, Greece
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 1400)
🇬🇷Athens, Attiki, Greece
Agios Loukas Clinic ( Site 1404)
🇬🇷Thessaloniki, Kentriki Makedonia, Greece
University General Hospital of Larissa-Oncology Clinic ( Site 1403)
🇬🇷Larissa, Thessalia, Greece
G. Papanikolaou General Hospital-Pulmonary Clinic of Aristotle University of Thessaloniki ( Site 1405)
🇬🇷Thessaloniki, Greece
Ospedale Santa Maria delle Croci ( Site 1606)
🇮🇹Ravenna, Emilia-Romagna, Italy
CRO-IRCCS-Clinical Oncology ( Site 1605)
🇮🇹Aviano, Friuli-Venezia Giulia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1601)
🇮🇹Roma, Lazio, Italy
Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno-UOC Oncologia Medica Livorno ( Site 1608)
🇮🇹Livorno, Toscana, Italy
National Hospital Organization Shikoku Cancer Center ( Site 3315)
🇯🇵Matsuyam, Ehime, Japan
National Hospital Organization Kyushu Cancer Center ( Site 3316)
🇯🇵Fukuoka,, Fukuoka, Japan
Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1609)
🇮🇹Rome, Roma, Italy
Nagoya University Hospital ( Site 3309)
🇯🇵Nagoya, Aichi, Japan
Fujita Health University Hospital ( Site 3310)
🇯🇵Toyoake, Aichi, Japan
Kurume University Hospital ( Site 3317)
🇯🇵Kurume, Fukuoka, Japan
Gunma Prefectural Cancer Center ( Site 3302)
🇯🇵Ota, Gunma, Japan
Kanazawa University Hospital ( Site 3308)
🇯🇵Kanazawa, Ishikawa, Japan
St. Marianna University Hospital ( Site 3320)
🇯🇵Kawasaki, Kanagawa, Japan
Matsusaka Municipal Hospital ( Site 3311)
🇯🇵Matsusaka, Mie, Japan
Miyagi Cancer Center ( Site 3301)
🇯🇵Natori, Miyagi, Japan
Sendai Kousei Hospital ( Site 3300)
🇯🇵Sendai, Miyagi, Japan
Kansai Medical University Hospital ( Site 3312)
🇯🇵Hirakata, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 3313)
🇯🇵Takatsuki, Osaka, Japan
Nippon Medical School Hospital ( Site 3306)
🇯🇵Bunkyo, Tokyo, Japan
Toho University Omori Medical Center ( Site 3319)
🇯🇵Ota, Tokyo, Japan
Tokyo Medical University Hospital ( Site 3307)
🇯🇵Shinjuku, Tokyo, Japan
National Center for Global Health and Medicine ( Site 3305)
🇯🇵Shinjuku, Tokyo, Japan
Chiba University Hospital ( Site 3322)
🇯🇵Chiba, Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 3314)
🇯🇵Hiroshima, Japan
Saiseikai Kumamoto Hospital ( Site 3318)
🇯🇵Kumamoto, Japan
Osaka Metropolitan University Hospital ( Site 3321)
🇯🇵Osaka, Japan
The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 3606)
🇰🇷Bupyeong-gu, Incheon, Korea, Republic of
Chonnam National University Hwasun Hospital-Pulmonology ( Site 3604)
🇰🇷Hwasun, Jeonranamdo, Korea, Republic of
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3600)
🇰🇷Suwon-si, Kyonggi-do, Korea, Republic of
Pusan National University Yangsan Hospital-Lung Cancer Clinic ( Site 3603)
🇰🇷Yangsan, Kyongsangnam-do, Korea, Republic of
Chungnam national university hospital ( Site 3602)
🇰🇷Jung-gu, Taejon-Kwangyokshi, Korea, Republic of
Kyung Hee University Hospital ( Site 3605)
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital ( Site 3601)
🇰🇷Seoul, Korea, Republic of
Arké SMO S.A. de C.V. ( Site 0602)
🇲🇽Mexico, Distrito Federal, Mexico
Oaxaca Site Management Organization S.C. ( Site 0603)
🇲🇽Oaxaca, Mexico
Ziekenhuis St. Jansdal-Poli Longziekten ( Site 1701)
🇳🇱Harderwijk, Gelderland, Netherlands
Isala, locatie Zwolle-Poli Longziekten ( Site 1700)
🇳🇱Zwolle, Overijssel, Netherlands
Universitair Medisch Centrum Utrecht ( Site 1704)
🇳🇱Utrecht, Netherlands
Auckland City Hospital ( Site 3400)
🇳🇿Auckland, New Zealand
Lung Center of the Philippines-Pulmonary, Critical Care and Sleep Medicine ( Site 3503)
🇵🇭Quezon City, National Capital Region, Philippines
Veterans Memorial Medical Center-Section of Oncology ( Site 3505)
🇵🇭Quezon City, National Capital Region, Philippines
Centrul de Oncologie Sfantul Nectarie-Medical ( Site 1994)
🇷🇴Craiova, Dolj, Romania
Cabinet Medical Oncomed ( Site 1998)
🇷🇴Timișoara, Timis, Romania
SC ONCO CARD SRL ( Site 1995)
🇷🇴Brasov, Romania
Institutul Oncologic Cluj-Oncologie Medicala ( Site 1999)
🇷🇴Cluj, Romania
Sigmedical Services SRL ( Site 1997)
🇷🇴Suceava, Romania
Hospital Insular de Gran Canaria-Oncology ( Site 2019)
🇪🇸Las Palmas de Gran Canaria, Las Palmas, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2012)
🇪🇸Madrid, Madrid, Comunidad De, Spain
H.R.U Málaga - Hospital General-Oncology ( Site 2014)
🇪🇸Málaga, Malaga, Spain
Hospital Universitari Vall d Hebron ( Site 2010)
🇪🇸Barcelona, Spain
Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 2017)
🇪🇸Madrid, Spain
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2015)
🇪🇸Sevilla, Spain
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2107)
🇹🇷Adana, Turkey
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2101)
🇹🇷Ankara, Turkey
Memorial Ankara Hastanesi-Medical Oncology ( Site 2106)
🇹🇷Ankara, Turkey
Medipol Mega Universite Hastanesi-oncology ( Site 2105)
🇹🇷Istanbul, Turkey
COMMUNAL NONPROFIT ENTERPRISE "CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 2209)
🇺🇦Cherkasy, Cherkaska Oblast, Ukraine
Regional Municipal Non-profit Enterprise "Bukovinian Clinica-structural unit of the clinical trials ( Site 2210)
🇺🇦Chernivtsi, Chernivetska Oblast, Ukraine
Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 2215)
🇺🇦Kryvyi Rih, Dnipropetrovska Oblast, Ukraine
Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 2202)
🇺🇦Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
Kirovohrad Regional Oncology Center-Chemotherapy department ( Site 2204)
🇺🇦Kropyvnytskyi, Kirovohradska Oblast, Ukraine
Medical Center "MedOffice Group" ( Site 2219)
🇺🇦Kiev, Kyivska Oblast, Ukraine
Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital ( Site 2217)
🇺🇦Lviv, Lvivska Oblast, Ukraine
Rivne Regional Clinical Hospital ( Site 2205)
🇺🇦Rivne, Rivnenska Oblast, Ukraine
Communal Noncommercial Enterprise "Podillia Regional Oncolog-Cardiothoracic department ( Site 2211)
🇺🇦Vinnytsia, Vinnytska Oblast, Ukraine
ME Volyn Regional Clinical Hospital of the Volyn Regional Council ( Site 2216)
🇺🇦Lutsk, Volynska Oblast, Ukraine