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)
- Conditions
- Small Cell Lung Cancer
- Interventions
- Drug: Platinum, investigator's choiceRadiation: Standard Thoracic RadiotherapyRadiation: Prophylactic Cranial Irradiation (PCI)
- Registration Number
- NCT04624204
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Researchers are looking for new ways to treat Limited-Stage Small Cell Lung Cancer (LS-SCLC), a type of lung cancer that has not spread from the lung to other parts of the body. The purpose of this study is to learn if pembrolizumab and olaparib, when given with chemotherapy and radiation treatment (CRT), can be effective in treating LS-SCLC. The researchers want to know if participants who receive CRT and pembrolizumab, with or without olaparib, have a longer overall survival compared to participants who only receive CRT.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 672
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Has pathologically (histologically or cytologically) confirmed Small Cell Lung Cancer (SCLC).
Note: Note: Participants with histology showing a mixed tumor with small cell and non-small cell elements are not eligible.
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Has Limited-Stage SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses.
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Has no evidence of metastatic disease by whole body positron emission tomography /computed tomography (PET/CT scan), CT or magnetic resonance imaging (MRI) scans
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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)
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Has not received prior treatment (chemotherapy or radiotherapy or surgery resection) of LS-SCLC.
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Is not expected to require tumor resection during the course of the study.
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Must submit a pre-treatment tumor tissue sample (formalin-fixed, paraffin embedded blocks are preferred to slides) including cytologic sample, if tissue sample unavailable.
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Has Eastern Cooperative Oncology Group (ECOG) Performance score 0 or 1 assessed within 7 days prior to the first administration of study intervention.
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Has a life expectancy of at least 6 months.
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Has adequate organ function.
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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.
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Male and female participants who are at least 18 years of age at the time of signing the information consent.
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Male participants must refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention.
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Abstains from breastfeeding during the study intervention period and for at least the following period after the last study intervention:
- Pembrolizumab: 120 days
- Olaparib: 7 days
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A - Pembrolizumab 200 mg 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. Group A - Pembrolizumab 200 mg Pembrolizumab 400 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. Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID Pembrolizumab 400 mg 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. Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID Etoposide 100 mg/m^2 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. Group C (Pembrolizumab and Olaparib Matching Placebos) Pembrolizumab placebo (saline) 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. Group C (Pembrolizumab and Olaparib Matching Placebos) Etoposide 100 mg/m^2 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. Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID 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. Group A - Pembrolizumab 200 mg Olaparib matching placebo 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. Group A - Pembrolizumab 200 mg Standard Thoracic Radiotherapy 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. Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID Standard Thoracic Radiotherapy 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. Group A - Pembrolizumab 200 mg Etoposide 100 mg/m^2 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. Group A - Pembrolizumab 200 mg Platinum, investigator's choice 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. Group A - Pembrolizumab 200 mg Prophylactic Cranial Irradiation (PCI) 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. Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID Pembrolizumab 200 mg 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. Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID Platinum, investigator's choice 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. Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID Prophylactic Cranial Irradiation (PCI) 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. Group C (Pembrolizumab and Olaparib Matching Placebos) Olaparib matching placebo 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. Group C (Pembrolizumab and Olaparib Matching Placebos) Platinum, investigator's choice 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. Group C (Pembrolizumab and Olaparib Matching Placebos) Standard Thoracic Radiotherapy 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. Group C (Pembrolizumab and Olaparib Matching Placebos) Prophylactic Cranial Irradiation (PCI) 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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 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.
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.
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.
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 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 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.
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.
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.
Trial Locations
- Locations (188)
Fairview Hospital-Moll Cancer Center ( Site 0141)
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Main ( Site 0139)
🇺🇸Cleveland, Ohio, United States
MD Anderson Cancer Center ( Site 0100)
🇺🇸Houston, Texas, United States
Millennium Research & Clinical Development ( Site 0143)
🇺🇸Houston, Texas, United States
CHU UCL Namur Site de Godinne ( Site 1004)
🇧🇪Yvoir, Namur, Belgium
Nacionalinis Vezio Institutas ( Site 2300)
🇱🇹Vilnius, Vilniaus Miestas, Lithuania
Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1704)
🇵🇹Lisboa, Portugal
Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2805)
🇷🇴Florești, Cluj, Romania
Communal Noncommercial Enterprise "Podillia Regional Oncolog-Chemotherapy Department ( Site 2114)
🇺🇦Vinnytsia, Vinnytska Oblast, Ukraine
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2803)
🇷🇴Cluj-Napoca, Cluj, Romania
Taunton and Somerset Hospital ( Site 2404)
🇬🇧Taunton, England, United Kingdom
Grand Hopital de Charleroi ( Site 1003)
🇧🇪Charleroi, Hainaut, Belgium
C.I.U. Hopital Ambroise Pare ( Site 1001)
🇧🇪Mons, Hainaut, Belgium
SA Tartu Ulikooli Kliinikum ( Site 2200)
🇪🇪Tartu, Tartumaa, Estonia
Institute for Oncology and Radiology of Serbia ( Site 2995)
🇷🇸Belgrade, Beograd, Serbia
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0404)
🇲🇽Monterrey, Nuevo Leon, Mexico
Medical Center Verum ( Site 2106)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0401)
🇲🇽Guadalajara, Jalisco, Mexico
Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107)
🇺🇦Dnipro, Dnipropetrovska Oblast, Ukraine
Municipal non-profit Enterprise "Khmelnytskyi Regional Antitumor Center" ( Site 2115)
🇺🇦Khmelnytskyi, Khmelnytska Oblast, Ukraine
Uzsoki Utcai Korhaz ( Site 1303)
🇭🇺Budapest, Hungary
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1306)
🇭🇺Kecskemét, Bacs-Kiskun, Hungary
Ironwood Cancer & Research Centers ( Site 0007)
🇺🇸Chandler, Arizona, United States
Georgetown University ( Site 0017)
🇺🇸Washington, District of Columbia, United States
University of Chicago Medical Center ( Site 0136)
🇺🇸Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology ( Site 0034)
🇺🇸Fort Wayne, Indiana, United States
University of Kentucky Chandler Medical Center ( Site 0138)
🇺🇸Lexington, Kentucky, United States
Harry & Jeanette Weinberg Cancer Institute ( Site 0045)
🇺🇸Baltimore, Maryland, United States
Overton Brooks VAMC ( Site 0041)
🇺🇸Shreveport, Louisiana, United States
Memorial Sloan Kettering - Basking Ridge ( Site 0133)
🇺🇸Basking Ridge, New Jersey, United States
St. Vincent Healthcare Frontier Cancer Center ( Site 0056)
🇺🇸Billings, Montana, United States
Memorial Sloan Kettering - Bergen ( Site 0130)
🇺🇸Montvale, New Jersey, United States
Rutgers Cancer Institute of New Jersey ( Site 0123)
🇺🇸New Brunswick, New Jersey, United States
Memorial Sloan Kettering - Westchester-Thoracic Oncology ( Site 0134)
🇺🇸Harrison, New York, United States
Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0140)
🇺🇸Mayfield Heights, Ohio, United States
Penn State Hershey Cancer Institute ( Site 0081)
🇺🇸Hershey, Pennsylvania, United States
Saint Francis Cancer Center ( Site 0087)
🇺🇸Greenville, South Carolina, United States
The University of Tennessee Medical Center ( Site 0116)
🇺🇸Knoxville, Tennessee, United States
Texas Oncology - Dallas (Presbyterian)_McIntyre ( Site 0098)
🇺🇸Dallas, Texas, United States
Texas Oncology - Dallas (Sammons) ( Site 0093)
🇺🇸Dallas, Texas, United States
Providence Regional Cancer Partnership ( Site 0106)
🇺🇸Everett, Washington, United States
Medical Oncology Associates, PS ( Site 0142)
🇺🇸Spokane, Washington, United States
Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0112)
🇺🇸Yakima, Washington, United States
Nepean Hospital ( Site 3001)
🇦🇺Kingswood, New South Wales, Australia
Calvary Mater Newcastle ( Site 3000)
🇦🇺Waratah, New South Wales, Australia
Gold Coast University Hospital ( Site 3003)
🇦🇺Southport, Queensland, Australia
Frankston Hospital-Oncology and Haematology ( Site 3007)
🇦🇺Frankston, Victoria, Australia
Austin Health-Austin Hospital ( Site 3006)
🇦🇺Heidelberg, Victoria, Australia
Western Health-Sunshine Hospital ( Site 3004)
🇦🇺St Albans, Victoria, Australia
Saint-Luc UCL ( Site 1005)
🇧🇪Brussels, Bruxelles-Capitale, Region De, Belgium
UZ Leuven ( Site 1002)
🇧🇪Leuven, Vlaams-Brabant, Belgium
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0212)
🇨🇦Hamilton, Ontario, Canada
Cross Cancer Institute ( Site 0206)
🇨🇦Edmonton, Alberta, Canada
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0202)
🇨🇦Montreal, Quebec, Canada
AZ Delta ( Site 1000)
🇧🇪Roeselare, West-Vlaanderen, Belgium
MHAT "Uni Hospital" OOD ( Site 2507)
🇧🇬Panagyurishte, Pazardzhik, Bulgaria
McGill University Health Centre ( Site 0210)
🇨🇦Montréal, Quebec, Canada
Cancer Hospital Chinese Academy of Medical Sciences ( Site 3104)
🇨🇳Beijing, Beijing, China
CIUSSS de la Mauricie et du Centre du Quebec ( Site 0200)
🇨🇦Trois-Rivieres, Quebec, Canada
Peking Union Medical College Hospital ( Site 3102)
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital ( Site 3127)
🇨🇳Beijing, Beijing, China
Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 3140)
🇨🇳Beijing, Beijing, China
Chongqing Cancer Hospital ( Site 3135)
🇨🇳Chongqing, Chongqing, China
Daping Hospital,Third Military Medical University ( Site 3136)
🇨🇳Chongqing, Chongqing, China
Fujian Provincial Cancer Hospital ( Site 3126)
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University ( Site 3121)
🇨🇳Xiamen, Fujian, China
Peking University Shenzhen Hospital ( Site 3118)
🇨🇳Shenzhen, Guangdong, China
Henan Cancer Hospital ( Site 3105)
🇨🇳Zhengzhou, Henan, China
Wuhan Union Hospital ( Site 3123)
🇨🇳Wuhan, Hubei, China
Tongji Medical College Huazhong University of Science and Technology ( Site 3138)
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 3133)
🇨🇳Changsha, Hunan, China
Hubei Cancer Hospital ( Site 3120)
🇨🇳Wuhan, Hubei, China
Xiangya Hospital of Central South University ( Site 3137)
🇨🇳Changsha, Hunan, China
The First Hospital of Jilin University ( Site 3132)
🇨🇳Changchun, Jilin, China
The Second Affiliated Hospital of Nanchang University ( Site 3106)
🇨🇳Nanchang, Jiangxi, China
Jiangsu Cancer Hospital ( Site 3139)
🇨🇳Nanjing, Jiangsu, China
Shandong Province Cancer Hospital ( Site 3100)
🇨🇳Jinan, Shandong, China
Shanghai Chest Hospital ( Site 3107)
🇨🇳Shangai, Shanghai, China
West China Hospital of Sichuan University ( Site 3114)
🇨🇳Chengdu, Sichuan, China
Shanghai Pulmonary Hospital ( Site 3101)
🇨🇳Shanghai, Shanghai, China
Tianjin Medical University Cancer Institute & Hospital ( Site 3103)
🇨🇳Tianjin, Tianjin, China
Hangzhou Cancer Hospital ( Site 3129)
🇨🇳Hanghzou, Zhejiang, China
The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3131)
🇨🇳Hangzhou, Zhejiang, China
SA Pohja-Eesti Regionaalhaigla ( Site 2201)
🇪🇪Tallinn, Harjumaa, Estonia
Clinique Clairval ( Site 1108)
🇫🇷Marseille, Bouches-du-Rhone, France
Institut De Cancerologie De L Ouest ( Site 1110)
🇫🇷Saint Herblain, Loire-Atlantique, France
Hopital Avicenne ( Site 1106)
🇫🇷Bobigny, Seine-Saint-Denis, France
Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1103)
🇫🇷Angers, Maine-et-Loire, France
H.I.A. Sainte-Anne ( Site 1101)
🇫🇷Toulon, Var, France
Henry Dunant Hospital ( Site 1205)
🇬🇷Athens, Attiki, Greece
Orszagos Onkologiai Intezet ( Site 1310)
🇭🇺Budapest, Hungary
Anti-Cancer Hospital of Thessaloniki Theagenio ( Site 1204)
🇬🇷Thessaloniki, Kentriki Makedonia, Greece
Petz Aladar Megyei Oktato Korhaz ( Site 1312)
🇭🇺Gyor, Gyor-Moson-Sopron, Hungary
University General Hospital of Larisa ( Site 1201)
🇬🇷Larissa, Thessalia, Greece
Orszagos Koranyi Pulmonologiai Intezet ( Site 1301)
🇭🇺Budapest, Hungary
Rambam Health Care Campus-Oncology Division ( Site 1401)
🇮🇱Haifa, Israel
Chaim Sheba Medical Center ( Site 1400)
🇮🇱Ramat Gan, Israel
Azienda Ospedaliera Spedali Civili di Brescia ( Site 1512)
🇮🇹Brescia, Italy
A O U Policlinico di Modena ( Site 1503)
🇮🇹Modena, Emilia-Romagna, Italy
Azienda Ospedaliero Universitaria Careggi ( Site 1509)
🇮🇹Florence, Firenze, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento-Oncology Unit ( Site 1513
🇮🇹Verona, Veneto, Italy
IRCCS Ospedale San Raffaele ( Site 1500)
🇮🇹Milano, Italy
Istituto Nazionale dei Tumori ( Site 1504)
🇮🇹Milano, Italy
IRCCS Istituto Oncologico Veneto ( Site 1506)
🇮🇹Padova, Italy
Istituto Europeo di Oncologia ( Site 1501)
🇮🇹Milano, Italy
Policlinico Universitario Agostino Gemelli ( Site 1505)
🇮🇹Roma, Italy
Aichi Cancer Center Hospital ( Site 4010)
🇯🇵Nagoya, Aichi, Japan
Kobe Minimally Invasive Cancer Center ( Site 4003)
🇯🇵Kobe, Hyogo, Japan
Kansai Medical University Hospital ( Site 4009)
🇯🇵Hirakata, Osaka, Japan
Kanagawa Cancer Center ( Site 4001)
🇯🇵Yokohama, Kanagawa, Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 4007)
🇯🇵Takatsuki, Osaka, Japan
National Hospital Organization Kyushu Cancer Center ( Site 4000)
🇯🇵Fukuoka, Japan
Okayama University Hospital ( Site 4012)
🇯🇵Okayama, Japan
Shizuoka Cancer Center ( Site 4014)
🇯🇵Nagaizumi, Shizuoka, Japan
Niigata Cancer Center Hospital ( Site 4004)
🇯🇵Niigata, Japan
Juntendo University Hospital ( Site 4008)
🇯🇵Tokyo, Japan
Osaka International Cancer Institute ( Site 4005)
🇯🇵Osaka, Japan
Tokyo Metropolitan Komagome Hospital ( Site 4011)
🇯🇵Tokyo, Japan
The Cancer Institute Hospital of JFCR ( Site 4006)
🇯🇵Tokyo, Japan
Showa University Hospital ( Site 4002)
🇯🇵Tokyo, Japan
The Catholic University of Korea St. Vincent s Hospital ( Site 3303)
🇰🇷Suwon-si, Kyonggi-do, Korea, Republic of
National Cancer Center ( Site 3306)
🇰🇷Goyang-si, Kyonggi-do, Korea, Republic of
Keimyung University Dongsan Hospital CRC room 1 ( Site 3302)
🇰🇷Daegu, Taegu-Kwangyokshi, Korea, Republic of
Seoul National University Bundang Hospital ( Site 3301)
🇰🇷Seongnam-si, Kyonggi-do, Korea, Republic of
LSMUL Kauno Klinikos ( Site 2301)
🇱🇹Kaunas, Lithuania
Samsung Medical Center ( Site 3300)
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 3304)
🇰🇷Seoul, Korea, Republic of
Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 1705)
🇵🇹Lisboa, Portugal
Spitalul Municipal Ploiesti ( Site 2801)
🇷🇴Ploiesti, Prahova, Romania
Moscow Regional Oncological Dispensary-Oncology (thoracic surgery) Department №1 ( Site 1815)
🇷🇺Balashikha, Moskovskaya Oblast, Russian Federation
S.C.Focus Lab Plus S.R.L ( Site 2804)
🇷🇴Bucuresti, Romania
Cabinet Medical Oncomed ( Site 2802)
🇷🇴Timisoara, Timis, Romania
Nizhniy Novgorod Region Oncology Dispensary ( Site 1811)
🇷🇺Nizhny Novgorod, Nizhegorodskaya Oblast, Russian Federation
MROI n.a. P.A. Herzen - branch of FSBI NMICR of MoH of Russia ( Site 1800)
🇷🇺Moscow, Moskva, Russian Federation
Omsk Clinical Oncology Dispensary ( Site 1806)
🇷🇺Omsk, Omskaya Oblast, Russian Federation
Sverdlovsk Regional Oncology Hospital ( Site 1807)
🇷🇺Ekaterinburg, Sverdlovskaya Oblast, Russian Federation
Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1814)
🇷🇺Kazan, Tatarstan, Respublika, Russian Federation
Groote Schuur Hospital ( Site 5002)
🇿🇦Cape Town, Western Cape, South Africa
Institut za plucne bolesti Vojvodine Sremska Kamenica ( Site 2991)
🇷🇸Sremska Kamenica, Sremski Okrug, Serbia
Steve Biko Academic Hospital ( Site 5000)
🇿🇦Pretoria, Gauteng, South Africa
Hospital Duran i Reynals ( Site 1903)
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitari Vall d Hebron ( Site 1904)
🇪🇸Barcelona, Spain
Hospital Universitario Central de Asturias ( Site 1900)
🇪🇸Oviedo, Asturias, Spain
Hospital Universitario 12 de Octubre ( Site 1902)
🇪🇸Madrid, Spain
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2009)
🇹🇷Istanbul, Turkey
Hospital Regional Universitario de Malaga ( Site 1905)
🇪🇸Malaga, Spain
Medipol Universite Hastanesi ( Site 2005)
🇹🇷Istanbul, Turkey
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1907)
🇪🇸Sevilla, Spain
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2110)
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
Ankara Bilkent Sehir Hastanesi ( Site 2007)
🇹🇷Ankara, Turkey
Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)
🇹🇷Izmir, Turkey
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2003)
🇹🇷Istanbul, Turkey
LISOD. Hospital ( Site 2111)
🇺🇦Pliuty, Kyiv, Ukraine
Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104)
🇺🇦Kapitanivka Village, Kyivska Oblast, Ukraine
Royal Infirmary Aberdeen ( Site 2403)
🇬🇧Aberdeen, Aberdeen City, United Kingdom
Clinic of National Cancer Institute ( Site 2101)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Kyiv City Clinical Oncology Center ( Site 2100)
🇺🇦Kyiv, Ukraine
Ninewells Hospital and Medical School ( Site 2401)
🇬🇧Dundee, Dundee City, United Kingdom
Guy s & St Thomas NHS Foundation Trust ( Site 2408)
🇬🇧London, London, City Of, United Kingdom
Multicare Institute For Research And Innovation ( Site 0108)
🇺🇸Tacoma, Washington, United States
Moffitt Cancer Center ( Site 0137)
🇺🇸Tampa, Florida, United States
VA Ann Arbor Healthcare System ( Site 0050)
🇺🇸Ann Arbor, Michigan, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0061)
🇺🇸Omaha, Nebraska, United States
John Theurer Cancer Center ( Site 0064)
🇺🇸Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center ( Site 0069)
🇺🇸New York, New York, United States
Campbelltown Hospital ( Site 3002)
🇦🇺Campbelltown, New South Wales, Australia
Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3113)
🇨🇳Shenzhen, Guangdong, China
Second Xiangya Hospital of Central-South University ( Site 3128)
🇨🇳Changsha, Hunan, China
CHU de Bordeaux Hop St ANDRE ( Site 1115)
🇫🇷Bordeaux, Aquitaine, France
Zhejiang Cancer Hospital.... ( Site 3108)
🇨🇳Hangzhou, Zhejiang, China
C.H. de Saint Quentin ( Site 1111)
🇫🇷Saint Quentin, Aisne, France
University General Hospital of Herakleion ( Site 1202)
🇬🇷Heraklion, Irakleio, Greece
CHU Grenoble -Hop Michallon ( Site 1102)
🇫🇷Grenoble, Isere, France
Sotiria Regional Chest Diseases Hospital of Athens ( Site 1200)
🇬🇷Athens, Attiki, Greece
Reformatus Pulmonologiai Centrum ( Site 1304)
🇭🇺Torokbalint, Pest, Hungary
Takarazuka City Hospital ( Site 4013)
🇯🇵Takarazuka, Hyogo, Japan
National Cancer Center Hospital ( Site 4015)
🇯🇵Tokyo, Japan
Inje University Haeundae Paik Hospital ( Site 3307)
🇰🇷Busan, Pusan-Kwangyokshi, Korea, Republic of
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 1701)
🇵🇹Porto, Portugal
Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 1812)
🇷🇺Moscow, Moskva, Russian Federation
Barts Health NHS Trust ( Site 2409)
🇬🇧London, London, City Of, United Kingdom
Memorial Sloan Kettering- Commack ( Site 0132)
🇺🇸Commack, New York, United States
Loma Linda University Cancer Center ( Site 0011)
🇺🇸Loma Linda, California, United States
Memorial Sloan Kettering - Nassau ( Site 0131)
🇺🇸Uniondale, New York, United States
Memorial Sloan Kettering - Monmouth ( Site 0135)
🇺🇸Middletown, New Jersey, United States
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1105)
🇫🇷Paris, Ile-de-France, France
Asan Medical Center ( Site 3308)
🇰🇷Songpagu, Seoul, Korea, Republic of
The Christie NHS Foundation Trust ( Site 2405)
🇬🇧Manchester, United Kingdom