Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)
Study Details
Study Description
Brief Summary
The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.
Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.
Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS.
Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A - Pembrolizumab 200 mg Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg every 6 weeks (Q6W) plus olaparib matching placebo twice daily (BID) for 12 months or until specific discontinuation criteria are met. |
Biological: Pembrolizumab 200 mg
Pembrolizumab 200 mg Q3W
Other Names:
Biological: Pembrolizumab 400 mg
Pembrolizumab 400 mg Q6W
Other Names:
Drug: Olaparib matching placebo
Olaparib matching placebo BID
Drug: Etoposide 100 mg/m^2
Etoposide 100 mg/m^2 intravenous (IV) Q3W, Day 1-3
Drug: Platinum, investigator's choice
Carboplatin titrated to an area under the plasma drug concentration time curve (AUC) of 5 mg/mL/min IV Q3W OR Cisplatin 75 mg/m^2 IV Q3W on Day 1 of each cycle
Radiation: Standard Thoracic Radiotherapy
Standard Thoracic Radiotherapy
Radiation: Prophylactic Cranial Irradiation (PCI)
PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
|
| Experimental: Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg Q6W plus olaparib 300 mg BID for 12 months or until specific discontinuation criteria are met. |
Biological: Pembrolizumab 200 mg
Pembrolizumab 200 mg Q3W
Other Names:
Biological: Pembrolizumab 400 mg
Pembrolizumab 400 mg Q6W
Other Names:
Drug: Olaparib 300 mg BID
Olaparib 300 mg twice daily (BID)
Other Names:
Drug: Etoposide 100 mg/m^2
Etoposide 100 mg/m^2 intravenous (IV) Q3W, Day 1-3
Drug: Platinum, investigator's choice
Carboplatin titrated to an area under the plasma drug concentration time curve (AUC) of 5 mg/mL/min IV Q3W OR Cisplatin 75 mg/m^2 IV Q3W on Day 1 of each cycle
Radiation: Standard Thoracic Radiotherapy
Standard Thoracic Radiotherapy
Radiation: Prophylactic Cranial Irradiation (PCI)
PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
|
| Placebo Comparator: Group C (Pembrolizumab and Olaparib Matching Placebos) Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab placebo (saline) Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab placebo (saline) Q6W plus olaparib matching placebo for 12 months or until specific discontinuation criteria are met. |
Drug: Pembrolizumab placebo (saline)
Pembrolizumab placebo (saline) Q3W
Drug: Pembrolizumab placebo (saline)
Pembrolizumab placebo (saline) Q6W
Drug: Olaparib matching placebo
Olaparib matching placebo BID
Drug: Etoposide 100 mg/m^2
Etoposide 100 mg/m^2 intravenous (IV) Q3W, Day 1-3
Drug: Platinum, investigator's choice
Carboplatin titrated to an area under the plasma drug concentration time curve (AUC) of 5 mg/mL/min IV Q3W OR Cisplatin 75 mg/m^2 IV Q3W on Day 1 of each cycle
Radiation: Standard Thoracic Radiotherapy
Standard Thoracic Radiotherapy
Radiation: Prophylactic Cranial Irradiation (PCI)
PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
|
Outcome Measures
Primary Outcome Measures
- Progression-free Survival Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); the time from randomization to progression or death due to any cause, whichever occurs first [Up to approximately 59 months]
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) is the time from randomization to progression or death due to any cause, whichever occurs first.
- Overall Survival: the time from randomization to death due to any cause [Up to approximately 82 months]
Overall Survival (OS) is the time from randomization to death due to any cause.
Secondary Outcome Measures
- Number of Participants Experiencing an Adverse Events (AEs) [Up to approximately 82 months]
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
- Number of Participants Discontinuing Study Treatment Due to Adverse Events (AEs) [Up to approximately 82 months]
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
- Objective Response (OR): Complete Response (CR) or Partial Response (PR) [Up to approximately 82 months]
Percentage of participants in the analysis population who have a best overall response of either confirmed CR or a PR per RECIST 1.1.
- Duration of Response (DOR): the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first [Up to approximately 82 months]
DOR is the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first.
- Change from Baseline at Cycle 1 in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 & 30) Scale Score [Baseline and 82 months post randomization]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scores will be presented.
- Change from Baseline at Cycle 1 in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score [Baseline and 82 months post randomization]
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score will be presented.
- Change from Baseline at Cycle 1 in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score [Baseline and 82 months post randomization]
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How was your chest pain?" 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. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score will be presented.
- Change from Baseline at Cycle 1 in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score [Baseline and 82 months post randomization]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" 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. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 dyspnea (Item 8) score will be presented.
- Change from Baseline at Cycle 1 in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score [Baseline and 82 months post randomization]
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. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented.
- Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score [Up to approximately 82 months post randomization]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 Items 29 and 30 scale scores.
- Time to True Deterioration (TTD) in Cough (LC13/Item 1) Scale Score [Up to approximately 82 months post randomization]
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in cough EORTC QLQLC13 cough (Item 1) scale score.
- Time to True Deterioration (TTD) in Chest Pain (LC13/Item 10) Scale Score [Up to approximately 82 months post randomization]
The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How was your chest pain?" 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. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-LC13 chest pain (Item 10) scale score.
- Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score [Up to approximately 82 months post randomization]
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" 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. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 dyspnea (Item 8) scale score.
- Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score [Up to approximately 82 months post randomization]
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. A higher score indicates a better quality of life. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in EORTC QLQ-C30 physical functioning (Items 1 to 5) scale scores.
- Objective Response (OR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels [Up to approximately 82 months]
Percentage of participants in the analysis population who have a best overall response of either confirmed CR or a PR per RECIST 1.1, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.
- Duration of Response (DOR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels [Up to approximately 82 months]
DOR is the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.
- Progression-free Survival (PFS, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels [Up to approximately 59 months]
Progression-free Survival Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); the time from randomization to progression or death due to any cause, whichever occurs first, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.
- Overall Survival (OS) assessed by programmed cell death ligand 1 (PD-L1) expression levels [Up to approximately 82 months]
Overall Survival: the time from randomization to death due to any cause, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Has pathologically (histologically or cytologically) confirmed Small Cell Lung Cancer (SCLC).
-
Has Limited-Stage SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses.
-
Has no evidence of metastatic disease by whole body positron emission tomography /computed tomography (PET/CT scan), CT or magnetic resonance imaging (MRI) scans
-
Has at least 1 lesion that meets the criteria for being measurable, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
-
Has not received prior treatment (chemotherapy or radiotherapy or surgery resection) of LS-SCLC.
-
Is not expected to require tumor resection during the course of the study.
-
Must submit a pre-treatment tumor tissue sample (formalin-fixed, paraffin embedded blocks are preferred to slides) including cytologic sample, if tissue sample unavailable.
-
Has Eastern Cooperative Oncology Group (ECOG) Performance score 0 or 1 assessed within 7 days prior to the first administration of study intervention.
-
Has a life expectancy of at least 6 months.
-
Has adequate organ function.
-
Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention.
-
Male and female participants who are at least 18 years of age at the time of signing the information consent.
-
Male participants must refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention.
Exclusion Criteria:
-
Has history, current diagnosis, or features suggestive of myelodysplastic syndrome/ acute myeloid leukemia (MDS/AML).
-
Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PDL1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
-
Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
-
Had major surgery <4 weeks prior to the first dose of study intervention (except for placement of vascular access).
-
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 a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
-
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
-
Has severe hypersensitivity (≥ Grade 3) to study intervention and/or any of its excipients.
-
Has an active autoimmune disease that has required systemic treatment in past 2 years
-
Has a history of (non-infectious) pneumonitis/interstitial lung disease that requires steroids
-
Has an active infection requiring systemic therapy.
-
Has a known history of human immunodeficiency virus (HIV) infection or Hepatitis B or known active Hepatitis C virus infection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ironwood Cancer & Research Centers ( Site 0007) | Chandler | Arizona | United States | 85224 |
| 2 | Loma Linda University Cancer Center ( Site 0011) | Loma Linda | California | United States | 92350 |
| 3 | Georgetown University ( Site 0017) | Washington | District of Columbia | United States | 20007 |
| 4 | Fort Wayne Medical Oncology and Hematology ( Site 0034) | Fort Wayne | Indiana | United States | 46804 |
| 5 | Overton Brooks VAMC ( Site 0041) | Shreveport | Louisiana | United States | 71101 |
| 6 | Harry & Jeanette Weinberg Cancer Institute ( Site 0045) | Baltimore | Maryland | United States | 21237 |
| 7 | VA Ann Arbor Healthcare System ( Site 0050) | Ann Arbor | Michigan | United States | 48105 |
| 8 | St. Vincent Healthcare Frontier Cancer Center ( Site 0056) | Billings | Montana | United States | 59102 |
| 9 | Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0061) | Omaha | Nebraska | United States | 68130 |
| 10 | Memorial Sloan Kettering - Basking Ridge ( Site 0133) | Basking Ridge | New Jersey | United States | 07920 |
| 11 | John Theurer Cancer Center ( Site 0064) | Hackensack | New Jersey | United States | 07601 |
| 12 | Memorial Sloan Kettering - Monmouth ( Site 0135) | Middletown | New Jersey | United States | 07748 |
| 13 | Memorial Sloan Kettering - Bergen ( Site 0130) | Montvale | New Jersey | United States | 07645 |
| 14 | Rutgers Cancer Institute of New Jersey ( Site 0123) | New Brunswick | New Jersey | United States | 08903 |
| 15 | Memorial Sloan Kettering- Commack ( Site 0132) | Commack | New York | United States | 11725 |
| 16 | Memorial Sloan Kettering - Westchester-Thoracic Oncology ( Site 0134) | Harrison | New York | United States | 10604 |
| 17 | Memorial Sloan Kettering Cancer Center ( Site 0069) | New York | New York | United States | 10021 |
| 18 | Memorial Sloan Kettering - Nassau ( Site 0131) | Uniondale | New York | United States | 11553 |
| 19 | Penn State Hershey Cancer Institute ( Site 0081) | Hershey | Pennsylvania | United States | 17033 |
| 20 | Saint Francis Cancer Center ( Site 0087) | Greenville | South Carolina | United States | 29607 |
| 21 | The University of Tennessee Medical Center ( Site 0116) | Knoxville | Tennessee | United States | 37920 |
| 22 | Texas Oncology - Dallas (Presbyterian)_McIntyre ( Site 0098) | Dallas | Texas | United States | 75231 |
| 23 | Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 0093) | Dallas | Texas | United States | 75246 |
| 24 | MD Anderson Cancer Center ( Site 0100) | Houston | Texas | United States | 77030 |
| 25 | Providence Regional Cancer Partnership ( Site 0106) | Everett | Washington | United States | 98201 |
| 26 | Multicare Institute For Research And Innovation ( Site 0108) | Tacoma | Washington | United States | 98405 |
| 27 | Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0112) | Yakima | Washington | United States | 98902 |
| 28 | Campbelltown Hospital ( Site 3002) | Campbelltown | New South Wales | Australia | 2560 |
| 29 | Nepean Hospital ( Site 3001) | Penrith | New South Wales | Australia | 2750 |
| 30 | Calvary Mater Newcastle ( Site 3000) | Waratah | New South Wales | Australia | 2298 |
| 31 | Gold Coast University Hospital ( Site 3003) | Southport | Queensland | Australia | 4215 |
| 32 | Frankston Hospital-Oncology and Haematology ( Site 3007) | Frankston | Victoria | Australia | 3199 |
| 33 | Austin Health-Austin Hospital ( Site 3006) | Heidelberg | Victoria | Australia | 3084 |
| 34 | Western Health-Sunshine Hospital ( Site 3004) | St Albans | Victoria | Australia | 3021 |
| 35 | C.I.U. Hopital Ambroise Pare ( Site 1001) | Mons | Hainaut | Belgium | 7000 |
| 36 | CHU UCL Namur Site de Godinne ( Site 1004) | Yvoir | Namur | Belgium | 5530 |
| 37 | UZ Leuven ( Site 1002) | Leuven | Vlaams-Brabant | Belgium | 3000 |
| 38 | AZ Delta ( Site 1000) | Roeselare | West-Vlaanderen | Belgium | 8800 |
| 39 | MHAT "Uni Hospital" OOD ( Site 2507) | Panagyurishte | Pazardzhik | Bulgaria | 4500 |
| 40 | Cross Cancer Institute ( Site 0206) | Edmonton | Alberta | Canada | T6G 1Z2 |
| 41 | CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0202) | Montreal | Quebec | Canada | H3T 1M5 |
| 42 | McGill University Health Centre ( Site 0210) | Montréal | Quebec | Canada | H4A 3J1 |
| 43 | CIUSSS de la Mauricie et du Centre du Quebec ( Site 0200) | Trois-Rivieres | Quebec | Canada | G8Z 3R9 |
| 44 | Peking Union Medical College Hospital ( Site 3102) | Beijing | Beijing | China | 100006 |
| 45 | Cancer Hospital Chinese Academy of Medical Sciences ( Site 3104) | Beijing | Beijing | China | 100021 |
| 46 | Beijing Cancer Hospital ( Site 3127) | Beijing | Beijing | China | 100142 |
| 47 | Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 3140) | Beijing | Beijing | China | 100142 |
| 48 | Chongqing Cancer Hospital ( Site 3135) | Chongqing | Chongqing | China | 400030 |
| 49 | Daping Hospital,Third Military Medical University ( Site 3136) | Chongqing | Chongqing | China | 400042 |
| 50 | Fujian Provincial Cancer Hospital ( Site 3126) | Fuzhou | Fujian | China | 350014 |
| 51 | The First Affiliated Hospital of Xiamen University ( Site 3121) | Xiamen | Fujian | China | 361003 |
| 52 | Peking University Shenzhen Hospital ( Site 3118) | Shenzhen | Guangdong | China | 518036 |
| 53 | Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3113) | Shenzhen | Guangdong | China | 518116 |
| 54 | Henan Cancer Hospital ( Site 3105) | Zhengzhou | Henan | China | 450008 |
| 55 | Wuhan Union Hospital ( Site 3123) | Wuhan | Hubei | China | 430022 |
| 56 | Tongji Medical College Huazhong University of Science and Technology ( Site 3138) | Wuhan | Hubei | China | 430030 |
| 57 | Hubei Cancer Hospital ( Site 3120) | Wuhan | Hubei | China | 430079 |
| 58 | Hunan Cancer Hospital ( Site 3133) | Changsha | Hunan | China | 410006 |
| 59 | Xiangya Hospital of Central South University ( Site 3137) | Changsha | Hunan | China | 410008 |
| 60 | Second Xiangya Hospital of Central-South University ( Site 3128) | Changsha | Hunan | China | 410011 |
| 61 | Jiangsu Cancer Hospital ( Site 3139) | Nanjing | Jiangsu | China | 210000 |
| 62 | The Second Affiliated Hospital of Nanchang University ( Site 3106) | Nanchang | Jiangxi | China | 330006 |
| 63 | The First Hospital of Jilin University ( Site 3132) | Changchun | Jilin | China | 130021 |
| 64 | Shandong Province Cancer Hospital ( Site 3100) | Jinan | Shandong | China | 250117 |
| 65 | Shanghai Chest Hospital ( Site 3107) | Shangai | Shanghai | China | 200030 |
| 66 | Shanghai Pulmonary Hospital ( Site 3101) | Shanghai | Shanghai | China | 200443 |
| 67 | West China Hospital of Sichuan University ( Site 3114) | Chengdu | Sichuan | China | 510115 |
| 68 | Tianjin Medical University Cancer Institute & Hospital ( Site 3103) | Tianjin | Tianjin | China | 300060 |
| 69 | Hangzhou Cancer Hospital ( Site 3129) | Hanghzou | Zhejiang | China | 310002 |
| 70 | The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3131) | Hangzhou | Zhejiang | China | 310003 |
| 71 | Zhejiang Cancer Hospital.... ( Site 3108) | Hangzhou | Zhejiang | China | 310022 |
| 72 | SA Pohja-Eesti Regionaalhaigla ( Site 2201) | Tallinn | Harjumaa | Estonia | 13419 |
| 73 | SA Tartu Ulikooli Kliinikum ( Site 2200) | Tartu | Tartumaa | Estonia | 51014 |
| 74 | C.H. de Saint Quentin ( Site 1111) | Saint Quentin | Aisne | France | 02321 |
| 75 | Clinique Clairval ( Site 1108) | Marseille | Bouches-du-Rhone | France | 13009 |
| 76 | CHU Grenoble -Hop Michallon ( Site 1102) | Grenoble | Isere | France | 38043 |
| 77 | Institut De Cancerologie De L Ouest ( Site 1110) | Saint Herblain | Loire-Atlantique | France | 44805 |
| 78 | Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1103) | Angers | Maine-et-Loire | France | 49000 |
| 79 | Hopital Avicenne ( Site 1106) | Bobigny | Seine-Saint-Denis | France | 93000 |
| 80 | H.I.A. Sainte-Anne ( Site 1101) | Toulon | Var | France | 83800 |
| 81 | Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1105) | Paris | France | 75014 | |
| 82 | Henry Dunant Hospital ( Site 1205) | Athens | Attiki | Greece | 115 26 |
| 83 | Sotiria Regional Chest Diseases Hospital of Athens ( Site 1200) | Athens | Attiki | Greece | 115 27 |
| 84 | University General Hospital of Herakleion ( Site 1202) | Heraklion | Irakleio | Greece | 711 10 |
| 85 | Anti-Cancer Hospital of Thessaloniki Theagenio ( Site 1204) | Thessaloniki | Kentriki Makedonia | Greece | 54007 |
| 86 | University General Hospital of Larisa ( Site 1201) | Larissa | Thessalia | Greece | 411 10 |
| 87 | Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1306) | Kecskemét | Bacs-Kiskun | Hungary | 6000 |
| 88 | Petz Aladar Megyei Oktato Korhaz ( Site 1312) | Gyor | Gyor-Moson-Sopron | Hungary | 9024 |
| 89 | Tudogyogyintezet Torokbalint ( Site 1304) | Torokbalint | Pest | Hungary | 2045 |
| 90 | Orszagos Koranyi Pulmonologiai Intezet ( Site 1301) | Budapest | Hungary | 1121 | |
| 91 | Orszagos Onkologiai Intezet ( Site 1310) | Budapest | Hungary | 1122 | |
| 92 | Uzsoki Utcai Korhaz ( Site 1303) | Budapest | Hungary | 1145 | |
| 93 | Rambam Health Care Campus-Oncology Division ( Site 1401) | Haifa | Israel | 3109601 | |
| 94 | A O U Policlinico di Modena ( Site 1503) | Modena | Emilia-Romagna | Italy | |
| 95 | Azienda Ospedaliero Universitaria Careggi ( Site 1509) | Florence | Firenze | Italy | 50134 |
| 96 | IRCCS Ospedale San Raffaele ( Site 1500) | Milano | Italy | 20132 | |
| 97 | Istituto Nazionale dei Tumori ( Site 1504) | Milano | Italy | 20133 | |
| 98 | Istituto Europeo di Oncologia ( Site 1501) | Milano | Italy | 20141 | |
| 99 | IRCCS Istituto Oncologico Veneto ( Site 1506) | Padova | Italy | 35128 | |
| 100 | Policlinico Universitario Agostino Gemelli ( Site 1505) | Roma | Italy | 00168 | |
| 101 | Aichi Cancer Center Hospital ( Site 4010) | Nagoya | Aichi | Japan | 464-8681 |
| 102 | Kobe Minimally Invasive Cancer Center ( Site 4003) | Kobe | Hyogo | Japan | 650-0046 |
| 103 | Takarazuka City Hospital ( Site 4013) | Takarazuka | Hyogo | Japan | 665-0827 |
| 104 | Kanagawa Cancer Center ( Site 4001) | Yokohama | Kanagawa | Japan | 241-8515 |
| 105 | Kansai Medical University Hospital ( Site 4009) | Hirakata | Osaka | Japan | 573-1191 |
| 106 | Osaka Medical and Pharmaceutical University Hospital ( Site 4007) | Takatsuki | Osaka | Japan | 569-8686 |
| 107 | Shizuoka Cancer Center ( Site 4014) | Nagaizumi | Shizuoka | Japan | 411-8777 |
| 108 | National Hospital Organization Kyushu Cancer Center ( Site 4000) | Fukuoka | Japan | 811-1395 | |
| 109 | Niigata Cancer Center Hospital ( Site 4004) | Niigata | Japan | 951-8566 | |
| 110 | Okayama University Hospital ( Site 4012) | Okayama | Japan | 7008558 | |
| 111 | Osaka International Cancer Institute ( Site 4005) | Osaka | Japan | 541-8567 | |
| 112 | National Cancer Center Hospital ( Site 4015) | Tokyo | Japan | 104-0045 | |
| 113 | Juntendo University Hospital ( Site 4008) | Tokyo | Japan | 113-0033 | |
| 114 | Tokyo Metropolitan Komagome Hospital ( Site 4011) | Tokyo | Japan | 113-8677 | |
| 115 | The Cancer Institute Hospital of JFCR ( Site 4006) | Tokyo | Japan | 135-8550 | |
| 116 | Showa University Hospital ( Site 4002) | Tokyo | Japan | 142-8666 | |
| 117 | National Cancer Center ( Site 3306) | Goyang-si | Kyonggi-do | Korea, Republic of | 10408 |
| 118 | The Catholic University of Korea St. Vincent s Hospital ( Site 3303) | Gyeonggi-do | Kyonggi-do | Korea, Republic of | 16247 |
| 119 | Seoul National University Bundang Hospital ( Site 3301) | Seongnam-si | Kyonggi-do | Korea, Republic of | 13620 |
| 120 | Inje University Haeundae Paik Hospital ( Site 3307) | Busan | Pusan-Kwangyokshi | Korea, Republic of | 48108 |
| 121 | Asan Medical Center ( Site 3308) | Songpagu | Seoul | Korea, Republic of | 05505 |
| 122 | Keimyung University Dongsan Hospital ( Site 3302) | Daegu | Taegu-Kwangyokshi | Korea, Republic of | 42601 |
| 123 | Severance Hospital Yonsei University Health System ( Site 3304) | Seoul | Korea, Republic of | 03722 | |
| 124 | Samsung Medical Center ( Site 3300) | Seoul | Korea, Republic of | 06351 | |
| 125 | Nacionalinis Vezio Institutas ( Site 2300) | Vilnius | Vilniaus Miestas | Lithuania | LT-08660 |
| 126 | LSMUL Kauno Klinikos ( Site 2301) | Kaunas | Lithuania | 50161 | |
| 127 | Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0401) | Guadalajara | Jalisco | Mexico | 44280 |
| 128 | Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0404) | Monterrey | Nuevo Leon | Mexico | 64460 |
| 129 | Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 1705) | Lisboa | Portugal | 1099-023 | |
| 130 | Moscow Regional Oncological Dispensary-Oncology (thoracic surgery) Department №1 ( Site 1815) | Balashikha | Moskovskaya Oblast | Russian Federation | 143900 |
| 131 | Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 1812) | Moscow | Moskva | Russian Federation | 105094 |
| 132 | MROI n.a. P.A. Herzen - branch of FSBI NMICR of MoH of Russia ( Site 1800) | Moscow | Moskva | Russian Federation | 125284 |
| 133 | Nizhniy Novgorod Region Oncology Dispensary ( Site 1811) | Nizhny Novgorod | Nizhegorodskaya Oblast | Russian Federation | 603081 |
| 134 | Omsk Clinical Oncology Dispensary ( Site 1806) | Omsk | Omskaya Oblast | Russian Federation | 644013 |
| 135 | Sverdlovsk Regional Oncology Hospital ( Site 1807) | Ekaterinburg | Sverdlovskaya Oblast | Russian Federation | 620036 |
| 136 | Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1814) | Kazan | Tatarstan, Respublika | Russian Federation | 420029 |
| 137 | Steve Biko Academic Hospital ( Site 5000) | Pretoria | Gauteng | South Africa | 0002 |
| 138 | Groote Schuur Hospital ( Site 5002) | Cape Town | Western Cape | South Africa | 7925 |
| 139 | Hospital Universitario Central de Asturias ( Site 1900) | Oviedo | Asturias | Spain | 33011 |
| 140 | Hospital Duran i Reynals ( Site 1903) | Hospitalet de Llobregat | Barcelona | Spain | 08908 |
| 141 | Hospital Universitari Vall d Hebron ( Site 1904) | Barcelona | Spain | 08035 | |
| 142 | Hospital Universitario 12 de Octubre ( Site 1902) | Madrid | Spain | 28041 | |
| 143 | Hospital Regional Universitario de Malaga ( Site 1905) | Malaga | Spain | 29010 | |
| 144 | Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1907) | Sevilla | Spain | 41009 | |
| 145 | Ankara Sehir Hastanesi ( Site 2007) | Ankara | Turkey | 06800 | |
| 146 | Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2009) | Istanbul | Turkey | 34098 | |
| 147 | Medipol Universite Hastanesi ( Site 2005) | Istanbul | Turkey | 34214 | |
| 148 | Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2003) | Istanbul | Turkey | 34722 | |
| 149 | Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001) | Izmir | Turkey | 35040 | |
| 150 | Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107) | Dnipro | Dnipropetrovska Oblast | Ukraine | 49055 |
| 151 | Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2110) | Kharkiv | Kharkivska Oblast | Ukraine | 61024 |
| 152 | Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104) | Kapitanivka Village | Kyivska Oblast | Ukraine | 08111 |
| 153 | Clinic of National Cancer Institute ( Site 2101) | Kyiv | Kyivska Oblast | Ukraine | 03022 |
| 154 | Medical Center Verum ( Site 2106) | Kyiv | Kyivska Oblast | Ukraine | 03039 |
| 155 | LISOD. Hospital ( Site 2111) | Pliuty | Kyiv | Ukraine | 08720 |
| 156 | Kyiv City Clinical Oncology Center ( Site 2100) | Kyiv | Ukraine | 03115 | |
| 157 | Royal Infirmary Aberdeen ( Site 2403) | Aberdeen | Aberdeen City | United Kingdom | AB25 2ZN |
| 158 | Ninewells Hospital and Medical School ( Site 2401) | Dundee | Dundee City | United Kingdom | DD1 9SY |
| 159 | Barts Health NHS Trust ( Site 2409) | London | London, City Of | United Kingdom | EC1A 7BE |
| 160 | Guy s & St Thomas NHS Foundation Trust ( Site 2408) | London | London, City Of | United Kingdom | SE1 9RT |
| 161 | Taunton and Somerset Hospital ( Site 2404) | Taunton | Somerset | United Kingdom | TA1 5DA |
| 162 | The Christie NHS Foundation Trust ( Site 2405) | Manchester | United Kingdom | M20 4GJ |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, MD, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 7339-013
- MK-7339-013
- jRCT2031200296
- 2019-003616-31