A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)
- Conditions
- Carcinoma, Squamous Cell, Non-small-cell Lung
- Interventions
- Registration Number
- NCT03976362
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are:
1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR).
2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS).
As of Amendment 07, there will be no further analyses for OS and patient-reported outcome assessments.
- Detailed Description
This study has 2 phases: an Induction Phase (4 Cycles) and a Maintenance Phase (Up to 31 cycles of pembrolizumab). In the Induction Phase, participants receive pembrolizumab plus carboplatin plus a taxane (paclitaxel or nab-paclitaxel). In the Maintenance Phase, participants with a partial or complete disease response or with stable disease after completing four cycles of induction therapy and who meet eligibility criteria will be randomly assigned to receive pembrolizumab plus maintenance olaparib OR pembrolizumab plus maintenance olaparib placebo. In the Maintenance Phase, participants randomly assigned to receive pembrolizumab for up to 31 cycles plus maintenance olaparib OR maintenance olaparib placebo until centrally verified progressive disease (PD), intolerable toxicities, or physician decision.
As of Amendment 07, participants actively taking placebo will discontinue taking the placebo intervention and continue in the study.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 851
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Have a histologically or cytologically confirmed diagnosis squamous NSCLC.
-
Have Stage IV squamous NSCLC.
-
Have measurable disease based on RECIST 1.1.
-
Have not received prior systemic treatment for their advanced/metastatic NSCLC.
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Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.
Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can receive study intervention(s). Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.
-
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention
-
Have a life expectancy of at least 3 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 180 days afterwards.
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Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards.
- Has non-squamous histology NSCLC.
- Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
- Has known active central nervous system metastases and/or carcinomatous meningitis.
- Has a known hypersensitivity to any components or excipients of carboplatin, paclitaxel or nab-paclitaxel, or olaparib.
- Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
- Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.
- Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment.
- Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
- Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
- Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab + Carboplatin + Taxane + Olaparib Nab-paclitaxel For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Pembrolizumab + Carboplatin + Taxane + Olaparib Placebo Nab-paclitaxel For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Pembrolizumab + Carboplatin + Taxane + Olaparib Carboplatin For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Pembrolizumab + Carboplatin + Taxane + Olaparib Placebo Pembrolizumab For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Pembrolizumab + Carboplatin + Taxane + Olaparib Placebo Placebo For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Pembrolizumab + Carboplatin + Taxane + Olaparib Olaparib For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Pembrolizumab + Carboplatin + Taxane + Olaparib Placebo Carboplatin For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Pembrolizumab + Carboplatin + Taxane + Olaparib Placebo Paclitaxel For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity. Pembrolizumab + Carboplatin + Taxane + Olaparib Paclitaxel For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity. Pembrolizumab + Carboplatin + Taxane + Olaparib Pembrolizumab For the Induction Phase, participants receive 4 cycles: Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy. For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) Up to approximately 39 months Progression-free Survival was defined as the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, progressive disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1 is presented. PFS is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Overall Survival (OS) Up to approximately 46 months Overall survival was the time from the date of randomization to death due to any cause. OS is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
- Secondary Outcome Measures
Name Time Method Number of Participants With One or More Adverse Events (AEs) Up to approximately 4 years An adverse event (AE) was 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 was considered related to the medical treatment or procedure, that occurred during the course of the study. The number of participants who reported 1 or more AEs is presented. Per protocol this outcome measure was not planned for the Induction Phase.
Number of Participants Who Discontinued Study Intervention Due to an AE Up to approximately 4 years An AE was 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 was considered related to the medical treatment or procedure, that occurred during the course of the study. The number of participants who discontinued study intervention due to an AE is presented. Per protocol this outcome measure was not planned for the Induction Phase.
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score Up to approximately 2 years 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 Item 8 scale score. The TTD for dyspnea (Item 8) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/ Quality of Life (QoL) (Items 29 and 30) Combined Scale Score Baseline and Week 24 EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the Global Health Status GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were each scored on a 7-point scale (1=Very Poor to 7=Excellent), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score was assessed using a constrained longitudinal data analysis (cLDA) model with the patient-reported outcome (PRO) score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 and 30) Scale Score Up to approximately 2 years TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Item 29) and QoL score (EORTC QLQ-C30 Item 30). 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 score, will be presented. A longer TTD indicates a better outcome. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score Baseline and Week 24 The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 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 is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score Up to approximately 2 years The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 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 scale score. The TTD for cough (Item 1) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score Baseline and Week 24 The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "Have you had pain in your chest?" 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 is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score Up to approximately 2 years The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "Have you had pain in your chest?" 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 chest pain scale score. The TTD for chest pain (Item 10) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score Baseline and Week 24 The EORTC QLQ-C30 is a 30-item 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. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score will be presented. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score Baseline and Week 24 The EORTC QLQ-C30 is a 30-item 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 is presented. Change from baseline score was assessed using a constrained longitudinal data analysis (cLDA) model with the patient-reported outcome (PRO) score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score Up to approximately 2 years 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 physical functioning Items 1 to 5 scale scores. The TTD for physical functioning (Item 1-5) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Trial Locations
- Locations (178)
Sanatorio Privado San Geronimo S.R.L ( Site 0510)
🇦🇷Santa Fe, Argentina
Thompson Cancer Survival Center ( Site 2812)
🇺🇸Knoxville, Tennessee, United States
Social Medical Center - Otto Wagner Hospital ( Site 1301)
🇦🇹Vienna, Wien, Austria
Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)
🇦🇹Wien, Austria
Arke Estudios Clinicos ( Site 0333)
🇲🇽Cdmx, Mexico
China Medical University Hospital ( Site 0904)
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital ( Site 0905)
🇨🇳Tainan, Taiwan
Newcastle Freeman Hospital ( Site 1902)
🇬🇧Newcastle-upon-Tyne, Newcastle Upon Tyne, United Kingdom
Hospital Tacchini ( Site 0265)
🇧🇷Bento Goncalves, Rio Grande Do Sul, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0255)
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
MedStar Franklin Square Medical Center ( Site 0044)
🇺🇸Baltimore, Maryland, United States
Waverly Hematology Oncology ( Site 0054)
🇺🇸Cary, North Carolina, United States
Renovatio Clinical ( Site 0074)
🇺🇸The Woodlands, Texas, United States
Mid-Florida Cancer Centers ( Site 0022)
🇺🇸Orange City, Florida, United States
Boca Raton Regional Hospital ( Site 0018)
🇺🇸Boca Raton, Florida, United States
Oncology of Northshore ( Site 0036)
🇺🇸Rolling Meadows, Illinois, United States
Disney Family Cancer Center ( Site 0005)
🇺🇸Burbank, California, United States
Mount Sinai Hospital Medical Center ( Site 0035)
🇺🇸Chicago, Illinois, United States
Columbus Regional Research Institute ( Site 0099)
🇺🇸Columbus, Georgia, United States
Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0039)
🇺🇸Merrillville, Indiana, United States
Barbara Ann Karmanos Cancer Institute ( Site 0046)
🇺🇸Detroit, Michigan, United States
Hattiesburg Clinic ( Site 0051)
🇺🇸Hattiesburg, Mississippi, United States
Frontier Oncology ( Site 0052)
🇺🇸Billings, Montana, United States
Cancer Care Northwest ( Site 0083)
🇺🇸Spokane Valley, Washington, United States
Monash Cancer Centre ( Site 1205)
🇦🇺Clayton, Victoria, Australia
Sanatorio Parque ( Site 0515)
🇦🇷Rosario, Santa Fe, Argentina
Liverpool Hospital ( Site 1201)
🇦🇺Liverpool, New South Wales, Australia
Innsbruck LKH ( Site 1302)
🇦🇹Innsbruck, Tirol, Austria
Southern Medical Day Care Centre ( Site 1200)
🇦🇺Wollongong, New South Wales, Australia
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0107)
🇨🇦Hamilton, Ontario, Canada
Hospital de Base de Sao Jose de Rio Preto ( Site 0254)
🇧🇷Sao Jose Rio Preto, Sao Paulo, Brazil
Hospital Sao Rafael ( Site 0258)
🇧🇷Salvador - BA, Bahia, Brazil
Hospital Paulistano - Amil Clinical Research ( Site 0263)
🇧🇷Sao Paulo, Brazil
Stronach Regional Cancer Centre ( Site 0100)
🇨🇦Newmarket, Ontario, Canada
Kingston Health Sciences Centre ( Site 0102)
🇨🇦Kingston, Ontario, Canada
CISSS de la Monteregie-Centre ( Site 0101)
🇨🇦Greenfield Park, Quebec, Canada
Centre Hospitalier De Chauny ( Site 1411)
🇫🇷Chauny, Aisne, France
Universitaetsklinikum Regensburg ( Site 1562)
🇩🇪Regensburg, Bayern, Germany
CHU Angers ( Site 1405)
🇫🇷Angers, Maine-et-Loire, France
Institut De Cancerologie De Lorraine ( Site 1409)
🇫🇷Vandoeuvre les Nancy, Meurthe-et-Moselle, France
Studienzentrum Aschaffenburg ( Site 1575)
🇩🇪Aschaffenburg, Bayern, Germany
Klinikum der LMU ( Site 1550)
🇩🇪Munich, Bayern, Germany
Centre Jean Perrin ( Site 1407)
🇫🇷Clermont Ferrand, Puy-de-Dome, France
CHU de Rouen ( Site 1403)
🇫🇷Rouen, Seine-Maritime, France
Universitaetsklinikum Frankfurt ( Site 1563)
🇩🇪Frankfurt, Hessen, Germany
Kanagawa Cancer Center ( Site 0807)
🇯🇵Yokohama, Kanagawa, Japan
Sendai Kousei Hospital ( Site 0812)
🇯🇵Sendai, Miyagi, Japan
Kansai Medical University Hospital ( Site 0804)
🇯🇵Hirakata, Osaka, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 0802)
🇯🇵Sunto-gun, Shizuoka, Japan
The Cancer Institute Hospital of JFCR ( Site 0800)
🇯🇵Tokyo, Japan
Helios Klinikum Erfurt GmbH ( Site 1552)
🇩🇪Erfurt, Thuringen, Germany
National Hospital Organization Nagoya Medical Center ( Site 0806)
🇯🇵Nagoya, Aichi, Japan
Aichi Cancer Center Hospital ( Site 0803)
🇯🇵Nagoya, Aichi, Japan
Katholisches Marienkrankenhaus gGmbH ( Site 1572)
🇩🇪Hamburg, Germany
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813)
🇯🇵Sakai, Osaka, Japan
National Hospital Organization Kyushu Medical Center ( Site 0805)
🇯🇵Fukuoka, Japan
The Catholic University of Korea St. Vincent s Hospital ( Site 1003)
🇰🇷Gyeonggi-do, Kyonggi-do, Korea, Republic of
Capital & Coast District Health Board - Wellington Hospital ( Site 1101)
🇳🇿Wellington, New Zealand
Chungbuk National University Hospital ( Site 1002)
🇰🇷Cheongju si, Chungbuk, Korea, Republic of
National Cancer Center ( Site 1006)
🇰🇷Goyang-si, Kyonggi-do, Korea, Republic of
Gyeongsang National University Hospital ( Site 1005)
🇰🇷Jinju, Kyongsangnam-do, Korea, Republic of
Ajou University Hospital ( Site 1004)
🇰🇷Suwon, Kyonggi-do, Korea, Republic of
Seoul National University Hospital ( Site 1000)
🇰🇷Seoul, Korea, Republic of
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0334)
🇲🇽Guadalajara, Jalisco, Mexico
Asan Medical Center ( Site 1007)
🇰🇷Songpa-gu, Seoul, Korea, Republic of
Korea University Guro Hospital ( Site 1008)
🇰🇷Seoul, Korea, Republic of
MidCentral DHB Palmerston North Hospital ( Site 1102)
🇳🇿Palmerston North, Manawatu-Wanganui, New Zealand
Severance Hospital Yonsei University Health System ( Site 1001)
🇰🇷Seoul, Korea, Republic of
Axis Heilsa S. de R.L. de C.V. ( Site 0301)
🇲🇽Monterrey, Nuevo Leon, Mexico
Investigacion Onco Farmaceutica S de RL de CV ( Site 0300)
🇲🇽La Paz, Baja California Sur, Mexico
FAICIC Clinical Research ( Site 0303)
🇲🇽Veracruz, Mexico
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 2417)
🇵🇱Olsztyn, Dolnoslaskie, Poland
Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)
🇵🇱Zgorzelec, Dolnoslaskie, Poland
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2508)
🇷🇴Craiova, Dolj, Romania
Moscow Regional Oncological Dispensary ( Site 2028)
🇷🇺Balashikha, Moskovskaya Oblast, Russian Federation
First Moscow State Medical University n.a. I.M.Sechenov ( Site 2024)
🇷🇺Moscow, Moskva, Russian Federation
FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 2006)
🇷🇺Moscow, Moskva, Russian Federation
Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site
🇷🇺Omsk, Omskaya Oblast, Russian Federation
Hospital Universitario Virgen Macarena ( Site 1712)
🇪🇸Sevilla, Spain
SPb SBHI City Clinical Oncological Dispensary ( Site 2001)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2021)
🇷🇺Kazan, Tatarstan, Respublika, Russian Federation
SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)
🇷🇺Samara, Samarskaya Oblast, Russian Federation
Bezmialem Vakif Univ. Tıp Fakultesi Hastanesi Tibbi Onkoloji Bolumu ( Site 2107)
🇹🇷Istanbul, Turkey
Complejo Hospitalario de Jaen ( Site 1713)
🇪🇸Jaen, La Coruna, Spain
Hospital Universitario 12 de Octubre ( Site 1716)
🇪🇸Madrid, Spain
Complejo Hospitalario de Malaga ( Site 1714)
🇪🇸Malaga, Spain
Chang Gung Medical Foundation.Linkou Branch ( Site 0903)
🇨🇳Taoyuan, Taiwan
Gazi Universitesi Tip Fakultesi ( Site 2104)
🇹🇷Ankara, Turkey
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2103)
🇹🇷Istanbul, Turkey
Ankara Sehir Hastanesi ( Site 2105)
🇹🇷Ankara, Turkey
Southend University Hospital NHS Foundation Trust ( Site 1913)
🇬🇧Westcliff-on-Sea, Essex, United Kingdom
PP PPC Acinus Medical and Diagnostic Centre ( Site 2223)
🇺🇦Kropyvnytskyi, Kirovohradska Oblast, Ukraine
Ege Universitesi Tip Fakultesi ( Site 2109)
🇹🇷Izmir, Turkey
West Suffolk Hospitals NHS Trust ( Site 1919)
🇬🇧Bury Saint Edmunds, Suffolk, United Kingdom
Barts Health NHS Trust - St Bartholomew s Hospital ( Site 1923)
🇬🇧London, London, City Of, United Kingdom
Chelsea and Westminster Hospital ( Site 1901)
🇬🇧London, London, City Of, United Kingdom
Birmingham Heartlands Hospital ( Site 1910)
🇬🇧Birmingham, United Kingdom
Centre Hospitalier de Pau ( Site 1412)
🇫🇷Pau, Pyrenees-Atlantiques, France
Western General Hospital, Edinburgh ( Site 1924)
🇬🇧Edinburg, United Kingdom
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0250)
🇧🇷Sao Paulo, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0260)
🇧🇷Sao Paulo, Brazil
Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1573)
🇩🇪Muenchen, Bayern, Germany
Klinikum Wuerzburg Mitte gGmbH ( Site 1559)
🇩🇪Wuerzburg, Bayern, Germany
Pneumologische Lehrklinik Universitaet Goettingen ( Site 1551)
🇩🇪Immenhausen, Hessen, Germany
InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1564)
🇩🇪Koblenz, Rheinland-Pfalz, Germany
Alabama Oncology Bruno Cancer Center ( Site 0001)
🇺🇸Birmingham, Alabama, United States
H. Lee Moffitt Cancer Center and Research Institute ( Site 0024)
🇺🇸Tampa, Florida, United States
Universitaetsmedizin Goettingen ( Site 1557)
🇩🇪Goettingen, Niedersachsen, Germany
Kliniken Essen Mitte ( Site 1567)
🇩🇪Essen, Nordrhein-Westfalen, Germany
Universitaetsklinikum Bonn ( Site 1574)
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Hospital Italiano Regional del Sur ( Site 0509)
🇦🇷Bahia Blanca, Buenos Aires, Argentina
Townsville General Hospital ( Site 1202)
🇦🇺Townsville, Queensland, Australia
Oncologica do Brasil ( Site 0256)
🇧🇷Belem, Para, Brazil
Klinikum Wels-Grieskirchen ( Site 1304)
🇦🇹Wels, Oberosterreich, Austria
Instituto do Cancer do Ceara ( Site 0251)
🇧🇷Fortaleza, Ceara, Brazil
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0253)
🇧🇷Rio de Janeiro, Brazil
CLIMERS Clinical Medical Research ( Site 0306)
🇲🇽Orizaba, Veracruz, Mexico
Osaka International Cancer Institute ( Site 0809)
🇯🇵Osaka, Japan
Cardiomed SRL Cluj-Napoca ( Site 2504)
🇷🇴Cluj Napoca, Cluj, Romania
SBHI Leningrad Regional Clinical Hospital ( Site 2002)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Hospital Sant Creu i Sant Pau ( Site 1711)
🇪🇸Barcelona, Spain
Ondokuz Mays Üniversitesi Tp Fakültesi Hastanesi-Oncology ( Site 2106)
🇹🇷Samsun, Turkey
Namik Kemal Universitesi Tip Fakultesi ( Site 2100)
🇹🇷Tekirdag, Tekirdas, Turkey
Hospital Duran i Reynals ( Site 1710)
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
National Taiwan University Hospital ( Site 0900)
🇨🇳Taipei, Taiwan
Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 2101)
🇹🇷Adana, Turkey
City Clinical Hosp.4 of DCC ( Site 2215)
🇺🇦Dnipro, Dnipropetrovska Oblast, Ukraine
Erciyes Universitesi Tip Fakultesi ( Site 2108)
🇹🇷Kayseri, Turkey
Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2227)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2226)
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
MI Precarpathian Clinical Oncology Center ( Site 2218)
🇺🇦Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
Colchester General Hospital ( Site 1911)
🇬🇧Colchester, Worcestershire, United Kingdom
Bozeman Health Deaconness Cancer Center ( Site 0053)
🇺🇸Bozeman, Montana, United States
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0516)
🇦🇷Mar del Plata, Buenos Aires, Argentina
Hospital Britanico de Buenos Aires ( Site 0500)
🇦🇷Buenos Aires, Caba, Argentina
Instituto Medico Rio Cuarto ( Site 0501)
🇦🇷Rio Cuarto, Cordoba, Argentina
Centro Medico San Roque ( Site 0506)
🇦🇷San Miguel de Tucuman, Tucuman, Argentina
Hospital Italiano de Buenos Aires ( Site 0511)
🇦🇷Buenos Aires, Argentina
Clínica Universitaria Reina Fabiola ( Site 0505)
🇦🇷Cordoba, Argentina
Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)
🇦🇹Linz, Oberosterreich, Austria
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0252)
🇧🇷Itajai, Santa Catarina, Brazil
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110)
🇨🇦Montreal, Quebec, Canada
CHU Caen ( Site 1406)
🇫🇷Caen, Calvados, France
Hopital Robert Schuman ( Site 1402)
🇫🇷Vantoux, Moselle, France
Hopital d'Instruction des Armees Begin ( Site 1413)
🇫🇷Saint-Mande, Val-de-Marne, France
National Cancer Center Hospital East ( Site 0801)
🇯🇵Kashiwa, Chiba, Japan
Nova Scotia Health Authority ( Site 0103)
🇨🇦Halifax, Nova Scotia, Canada
Hopital Cite de la Sante de Laval ( Site 0105)
🇨🇦Laval, Quebec, Canada
Kurume University Hospital ( Site 0814)
🇯🇵Kurume, Fukuoka, Japan
Kanazawa University Hospital ( Site 0811)
🇯🇵Kanazawa, Ishikawa, Japan
Niigata Cancer Center Hospital ( Site 0808)
🇯🇵Niigata, Japan
Okayama University Hospital ( Site 0810)
🇯🇵Okayama, Japan
Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420)
🇵🇱Krakow, Malopolskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
🇵🇱Warszawa, Mazowieckie, Poland
Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402)
🇵🇱Raciborz, Slaskie, Poland
Przychodnia Lekarska Komed ( Site 2416)
🇵🇱Konin, Wielkopolskie, Poland
MED-POLONIA Sp. z o.o. ( Site 2419)
🇵🇱Poznan, Wielkopolskie, Poland
S.C. Radiotherapy Center Cluj S.R.L ( Site 2507)
🇷🇴Cluj-Napoca, Cluj, Romania
Policlinica Oncomed SRL ( Site 2505)
🇷🇴Timisoara, Timis, Romania
S.C.Focus Lab Plus S.R.L ( Site 2502)
🇷🇴Bucuresti, Romania
Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 2000)
🇷🇺Moscow, Moskva, Russian Federation
Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2009)
🇷🇺Moscow, Moskva, Russian Federation
Spitalul Clinic Judetean de Urgenta Sf Apostol Andrei ( Site 2501)
🇷🇴Constanta, Romania
Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)
🇷🇺Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation
SPb Central Clinical Railway Hospital ( Site 2003)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 2004)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907)
🇨🇳Kaohsiung, Taiwan
Medical Center Asklepion LLC ( Site 2243)
🇺🇦Khodosivka, Kyivska Oblast, Ukraine
Kyiv City Clinical Oncology Centre ( Site 2224)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Medical Center Verum ( Site 2228)
🇺🇦Kyiv, Ukraine
Cherkasy Regional Oncology Dispensary ( Site 2225)
🇺🇦Cherkasy, Cherkaska Oblast, Ukraine
Regional Centre of Oncology-Thoracic organs ( Site 2219)
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
MI Odessa Regional Oncological Centre ( Site 2222)
🇺🇦Odesa, Odeska Oblast, Ukraine
Singleton Hospital ( Site 1909)
🇬🇧Swansea, Wales, United Kingdom
Central City Clinical Hospital ( Site 2221)
🇺🇦Uzhgorod, Zakarpatska Oblast, Ukraine
Centro Oncológico de Rosario ( Site 0507)
🇦🇷Rosario, Santa Fe, Argentina
CIUSSS de la Mauricie et du Centre du Quebec ( Site 0106)
🇨🇦Trois-Rivieres, Quebec, Canada
Mackay Memorial Hospital ( Site 0902)
🇨🇳Taipei, Taiwan