Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)
- Conditions
- Lung NeoplasmsCarcinoma, Non-Small-Cell Lung
- Interventions
- Registration Number
- NCT04380636
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are:
1. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS)
2. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 870
- Has pathologically (histologically or cytologically) confirmed diagnosis of NSCLC
- Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8
- Is unable to undergo surgery with curative intent for Stage III NSCLC
- Has no evidence of metastatic disease indicating Stage IV NSCLC
- Has measurable disease as defined by RECIST 1.1
- Has not received prior treatment (chemotherapy, targeted therapy or radiotherapy) for Stage III NSCLC; participants who have received neoadjuvant and/or adjuvant therapy for early stage disease are not eligible
- Has provided a tumor tissue sample (tissue biopsy [core, incisional, or excisional])
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study intervention
- Has a life expectancy of at least 6 months
- A male participant must agree to use contraception and refrain from donating sperm during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention unless confirmed to be azoospermic (vasectomized or secondary to medical cause). The length of time required to continue contraception for each study intervention is as follows: Olaparib, platinum doublet, and radiotherapy: 90 days
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use contraception and refrain from donating eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during the treatment period and for at least the time needed to eliminate each study intervention after the last dose of study intervention and agrees to abstain from breastfeeding during the study intervention period and for at least 120 days after the last dose of study intervention. The length of time required to continue contraception for each study intervention is as follows: Pembrolizumab: 120 days; Olaparib, platinum doublet, and radiotherapy: 180 days
- Has a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours for urine or within 72 hours for serum before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- Has had her medical history, menstrual history, and recent sexual activity reviewed by the investigator to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- Has adequate pulmonary function tests
- Has adequate organ function
- Has provided written informed consent
- Has small cell lung cancer or a mixed tumor with presence of small cell elements
- Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
- Has had documented weight loss >10% (from baseline) in the preceding 3 months
- Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer
- Has received prior therapy with an anti-programmed cell death 1 (ant-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor
- Has had major surgery <4 weeks prior to the first dose of study treatment (except for placement of vascular access)
- Is expected to require any other form of antineoplastic therapy, while on study
- Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention; administration of killed vaccines is allowed
- Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [GCSF], granulocyte-macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 28 days prior to the first dose of study treatment
- Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study
- Is currently receiving either strong (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
- Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days before, during, and for at least 2 days after administration of pemetrexed
- Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone during administration of pemetrexed
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study treatment
- The presence of uncontrolled, potentially reversible cardiac conditions, as judged by the investigator or has congenital long QT syndrome
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy 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 with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (excluding carcinoma-in situ-of the bladder) that have undergone potentially curative therapy
- 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 (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of Hepatitis B or known active Hepatitis C virus infection
- Has active tuberculosis (TB; Mycobacterium tuberculosis) and is receiving treatment
- Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
- Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease in the opinion of the treating investigator
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
- Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption
- Has had an allogenic tissue/solid organ transplant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description pembrolizumab+chemoradiation→pembrolizumab+olaparib Thoracic Radiotherapy Participants will receive pembrolizumab 200 mg IV Q3W in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by pembrolizumab plus olaparib 300 mg BID for approximately 1 year. pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo Placebo for olaparib Participants will receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray (Gy) over 6 weeks) followed by pembrolizumab plus olaparib placebo twice a day (BID) for approximately 1 year. pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo Thoracic Radiotherapy Participants will receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray (Gy) over 6 weeks) followed by pembrolizumab plus olaparib placebo twice a day (BID) for approximately 1 year. pembrolizumab+chemoradiation→pembrolizumab+olaparib Pembrolizumab Participants will receive pembrolizumab 200 mg IV Q3W in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by pembrolizumab plus olaparib 300 mg BID for approximately 1 year. chemoradiation→durvalumab Etoposide Participants will receive 3 cycles of the investigator's choice of platinum doublet chemotherapy with concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by durvalumab 10 mg/kg every 2 weeks (Q2W) for approximately 1 year. chemoradiation→durvalumab Thoracic Radiotherapy Participants will receive 3 cycles of the investigator's choice of platinum doublet chemotherapy with concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by durvalumab 10 mg/kg every 2 weeks (Q2W) for approximately 1 year. pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo Etoposide Participants will receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray (Gy) over 6 weeks) followed by pembrolizumab plus olaparib placebo twice a day (BID) for approximately 1 year. pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo Carboplatin Participants will receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray (Gy) over 6 weeks) followed by pembrolizumab plus olaparib placebo twice a day (BID) for approximately 1 year. pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo Cisplatin Participants will receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray (Gy) over 6 weeks) followed by pembrolizumab plus olaparib placebo twice a day (BID) for approximately 1 year. pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo Paclitaxel Participants will receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray (Gy) over 6 weeks) followed by pembrolizumab plus olaparib placebo twice a day (BID) for approximately 1 year. pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo Pemetrexed Participants will receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray (Gy) over 6 weeks) followed by pembrolizumab plus olaparib placebo twice a day (BID) for approximately 1 year. pembrolizumab+chemoradiation→pembrolizumab+olaparib Olaparib Participants will receive pembrolizumab 200 mg IV Q3W in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by pembrolizumab plus olaparib 300 mg BID for approximately 1 year. pembrolizumab+chemoradiation→pembrolizumab+olaparib Etoposide Participants will receive pembrolizumab 200 mg IV Q3W in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by pembrolizumab plus olaparib 300 mg BID for approximately 1 year. pembrolizumab+chemoradiation→pembrolizumab+olaparib Cisplatin Participants will receive pembrolizumab 200 mg IV Q3W in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by pembrolizumab plus olaparib 300 mg BID for approximately 1 year. pembrolizumab+chemoradiation→pembrolizumab+olaparib Carboplatin Participants will receive pembrolizumab 200 mg IV Q3W in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by pembrolizumab plus olaparib 300 mg BID for approximately 1 year. pembrolizumab+chemoradiation→pembrolizumab+olaparib Paclitaxel Participants will receive pembrolizumab 200 mg IV Q3W in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by pembrolizumab plus olaparib 300 mg BID for approximately 1 year. chemoradiation→durvalumab Pemetrexed Participants will receive 3 cycles of the investigator's choice of platinum doublet chemotherapy with concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by durvalumab 10 mg/kg every 2 weeks (Q2W) for approximately 1 year. chemoradiation→durvalumab Carboplatin Participants will receive 3 cycles of the investigator's choice of platinum doublet chemotherapy with concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by durvalumab 10 mg/kg every 2 weeks (Q2W) for approximately 1 year. chemoradiation→durvalumab Cisplatin Participants will receive 3 cycles of the investigator's choice of platinum doublet chemotherapy with concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by durvalumab 10 mg/kg every 2 weeks (Q2W) for approximately 1 year. chemoradiation→durvalumab Paclitaxel Participants will receive 3 cycles of the investigator's choice of platinum doublet chemotherapy with concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by durvalumab 10 mg/kg every 2 weeks (Q2W) for approximately 1 year. chemoradiation→durvalumab Durvalumab Participants will receive 3 cycles of the investigator's choice of platinum doublet chemotherapy with concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by durvalumab 10 mg/kg every 2 weeks (Q2W) for approximately 1 year. pembrolizumab+chemoradiation→pembrolizumab+olaparib Pemetrexed Participants will receive pembrolizumab 200 mg IV Q3W in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy over 6 weeks) followed by pembrolizumab plus olaparib 300 mg BID for approximately 1 year. pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo Pembrolizumab Participants will receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) in combination with 3 cycles of the investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray (Gy) over 6 weeks) followed by pembrolizumab plus olaparib placebo twice a day (BID) for approximately 1 year.
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) Up to approximately 48 months PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Overall Survival (OS) Up to approximately 72 months OS is the time from randomization to death due to any cause.
- Secondary Outcome Measures
Name Time Method Discontinuation Rate of Study Intervention Due to an Adverse Event (AE) Up to approximately 72 months An AE is defined as as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score Baseline (at randomization) and at the end of study (approximately 72 months post randomization) The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The physical functioning scale consists of participant responses to 5 questions regarding performance of daily activities \[1) strenuous activities; 2) long walks; 3) short walks; 4) bed/chair rest; and 5) needing help with eating, dressing, washing themselves or using the toilet\]. Participant responses 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, with a higher score indicating a better quality of life. The change from baseline in the EORTC QLQ-C30 physical functioning scale score will be presented.
Incidence of Adverse Events (AE) Up to approximately 72 months An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) Up to approximately 72 months ORR is defined as the percentage of participants who have achieved a Complete Response (CR) or a Partial Response (PR).
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) Up to approximately 72 months DOR is defined as the time from first documented evidence of Complete Response (CR) or a Partial Response (PR) until disease progression or death due to any cause, whichever occurs first.
Change from Baseline in EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Scale Score Baseline (at randomization) and at the end of study (approximately 72 months post randomization) The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scale scores will be presented.
Change From Baseline in Cough Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) Item 1 Score Baseline (at randomization) and at the end of study (approximately 72 months post randomization) The EORTC QLQ-LC13 is a supplemental lung cancer-specific questionnaire that includes a single-item scale score for cough (Item 1). For this item, individual responses to the question "How much did you cough?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-LC13 cough scale score will be presented.
Change From Baseline in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score Baseline (at randomization) and at the end of study (approximately 72 months post randomization) The EORTC QLQ-LC13 is a supplemental lung cancer-specific questionnaire that includes a single-item scale score for chest pain (Item 10). For this item, individual responses to the question "Have you had pain in your chest?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-LC13 chest pain scale score will be presented.
Change From Baseline in Dyspnea Using the EORTC QLQ-C30 Item 8 Score Baseline (at randomization) and at the end of study (approximately 72 months post randomization) The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients and includes a single-item scale score for dyspnea (Item 8). 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, with a lower score indicating a better outcome. The change from baseline in the EORTC QLQ-C30 dyspnea scale score will be presented.
Change from Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6-7 Score Baseline (at randomization) and at the end of study (approximately 72 months post randomization) The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The role functioning scale consists of participant responses to 2 questions regarding limitations in doing work or other activities and pursuing hobbies or leisure activities. Participant responses 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, with a higher score indicating a better quality of life. The change from baseline in the EORTC QLQ-C30 role functioning scale score will be presented.
Time to Deterioration (TTD) in HRQoL Using the EORTC QLQ-C30 Items 29 and 30 Score Up to approximately 72 months post randomization TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-C30 Items 29 and 30 scale scores. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.
TTD in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score Up to approximately 72 months post randomization TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-LC13 Item 10 scale score. The EORTC QLQ-LC13 is a supplemental lung cancer-specific questionnaire that includes a single-item scale score for chest pain (Item 10). For this item, individual responses to the question "Have you had pain in your chest?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a lower score indicating a better outcome.
TTD in Dyspnea Using the EORTC QLQ-C30 Item 8 Score Up to approximately 72 months post randomization TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-C30 Item 8 scale score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients and includes a single-item scale score for dyspnea (Item 8). 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, with a lower score indicating a better outcome.
TTD in Cough Using the EORTC QLQ-LC13 Item 1 Score Up to approximately 72 months post randomization TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-LC13 Item 1 scale score. The EORTC QLQ-LC13 is a supplemental lung cancer-specific questionnaire that includes a single-item scale score for cough (Item 1). For this item, individual responses to the question "How much did you cough?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a lower score indicating a better outcome.
TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score Up to approximately 72 months post randomization TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-C30 Items 1-5 scale scores. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The physical functioning scale consists of participant responses to 5 questions regarding performance of daily activities \[1) strenuous activities; 2) long walks; 3) short walks; 4) bed/chair rest; and 5) needing help with eating, dressing, washing themselves or using the toilet\]. Participant responses 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, with a higher score indicating a better quality of life.
TTD in Role Functioning Using the EORTC QLQ-C30 Items 6-7 Score Up to approximately 72 months post randomization TTD is defined as the time to first onset of a ≥10-point decrease from baseline for EORTC QLQ-C30 Items 6-7 scale scores. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The role functioning scale consists of participant responses to 2 questions regarding limitations in doing work or other activities and pursuing hobbies or leisure activities. Participant responses 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, with a higher score indicating a better quality of life.
Trial Locations
- Locations (205)
Torrance Memorial Physician Network / Cancer Center ( Site 0093)
🇺🇸Torrance, California, United States
UCLA Hematology/Oncology - Santa Monica ( Site 0013)
🇺🇸Los Angeles, California, United States
Miami VA Healthcare System ( Site 0024)
🇺🇸Miami, Florida, United States
Massachusetts General Hospital ( Site 0038)
🇺🇸Boston, Massachusetts, United States
Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0075)
🇺🇸Seattle, Washington, United States
Xiangya Hospital of Central South University ( Site 3637)
🇨🇳Changsha, Hunan, China
Hunan Cancer Hospital ( Site 3225)
🇨🇳Changsha, Hunan, China
Shanghai Chest Hospital ( Site 3207)
🇨🇳Shangai, Shanghai, China
Tianjin Medical University Cancer Institute & Hospital ( Site 3204)
🇨🇳Tianjin, Tianjin, China
Zhongshan Hospital Fudan University ( Site 3220)
🇨🇳Shanghai, Shanghai, China
Shanghai Pulmonary Hospital ( Site 3203)
🇨🇳Shanghai, Shanghai, China
The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3232)
🇨🇳Hangzhou, Zhejiang, China
Centre Hospitalier Annecy Genevois ( Site 0811)
🇫🇷Epagny Metz Tessy, Haute-Savoie, France
University of South Alabama, Mitchell Cancer Institute ( Site 0003)
🇺🇸Mobile, Alabama, United States
St Joseph Heritage Healthcare-Oncology ( Site 0088)
🇺🇸Fullerton, California, United States
St. Joseph Heritage Healthcare Local Lab ( Site 0011)
🇺🇸Santa Rosa, California, United States
St. Bernards Medical Center ( Site 0089)
🇺🇸Jonesboro, Arkansas, United States
Long Beach Memorial Medical Center ( Site 0006)
🇺🇸Long Beach, California, United States
Memorial Regional Hospital-Memorial Cancer Institute ( Site 0095)
🇺🇸Hollywood, Florida, United States
Mid Florida Hematology and Oncology Center ( Site 0022)
🇺🇸Orange City, Florida, United States
Parkview Research Center ( Site 0032)
🇺🇸Fort Wayne, Indiana, United States
West China Hospital of Sichuan University ( Site 3202)
🇨🇳Chengdu, Sichuan, China
University of Kentucky ( Site 0096)
🇺🇸Lexington, Kentucky, United States
Novant Health Presbyterian ( Site 0081)
🇺🇸Charlotte, North Carolina, United States
Hubei Cancer Hospital ( Site 3218)
🇨🇳Wuhan, Hubei, China
Fakultni nemocnice Kralovske Vinohrady-Radioterapeuticka a onkologicka klinika ( Site 2200)
🇨🇿PRague, Praha 10, Czechia
Beijing Cancer Hospital ( Site 3224)
🇨🇳Beijing, Beijing, China
Pikeville Medical Center ( Site 0036)
🇺🇸Pikeville, Kentucky, United States
The Valley Hospital ( Site 0056)
🇺🇸Paramus, New Jersey, United States
Franciscan Health Lafayette East ( Site 0031)
🇺🇸Lafayette, Indiana, United States
Montefiore Einstein Center ( Site 0083)
🇺🇸Bronx, New York, United States
Sanford Cancer Center Oncology Clinic ( Site 0066)
🇺🇸Sioux Falls, South Dakota, United States
Queen Elizabeth II Health Sciences Centre ( Site 0100)
🇨🇦Halifax, Nova Scotia, Canada
Peking University Shenzhen Hospital ( Site 3216)
🇨🇳Shenzhen, Guangdong, China
Hunan Cancer Hospital ( Site 3238)
🇨🇳Changsha, Hunan, China
The Lindner Center for Research and Education at The Christ Hospital ( Site 0060)
🇺🇸Cincinnati, Ohio, United States
Cancer Care Northwest ( Site 0074)
🇺🇸Spokane Valley, Washington, United States
McGill University Health Center - Research Institute ( Site 0114)
🇨🇦Montreal, Quebec, Canada
Jiangsu Cancer Hospital ( Site 3234)
🇨🇳Nanjing, Jiangsu, China
Bradford Hill Norte ( Site 0204)
🇨🇱Antofagasta, Chile
Second Xiangya Hospital of Central-South University ( Site 3227)
🇨🇳Changsha, Hunan, China
CHD Vendee ( Site 0807)
🇫🇷La Roche sur Yon, Vendee, France
GEHO Muenster ( Site 0910)
🇩🇪Muenster, Nordrhein-Westfalen, Germany
Beijing Cancer Hospital ( Site 3212)
🇨🇳Beijing, Beijing, China
Vseobecna fakultni nemocnice v Praze ( Site 2208)
🇨🇿Praha 2, Czechia
Masarykuv onkologicky ustav ( Site 2206)
🇨🇿Brno, Brno-mesto, Czechia
Krajska nemocnice Liberec, a.s. ( Site 2209)
🇨🇿Liberec, Czechia
Henan Cancer Hospital ( Site 3205)
🇨🇳Zhengzhou, Henan, China
Peking Union Medical College Hospital ( Site 3201)
🇨🇳Beijing, Beijing, China
C.H.R.U. de Brest - Hopital Morvan ( Site 0806)
🇫🇷Brest, Bretagne, France
Tartu University Hospital ( Site 1600)
🇪🇪Tartu, Tartumaa, Estonia
Daping Hospital,Third Military Medical University ( Site 3235)
🇨🇳Chongqing, Chongqing, China
Fujian Provincial Cancer Hospital ( Site 3226)
🇨🇳Fuzhou, Fujian, China
Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3200)
🇨🇳Shenzhen, Guangdong, China
Universitätsmedizin Göttingen - Georg-August-Universität ( Site 0917)
🇩🇪Göttingen, Niedersachsen, Germany
Clinique de l'Europe-Service de pneumologie ( Site 0816)
🇫🇷Amiens, Somme, France
Nemocnice Na Plesi s.r.o. ( Site 2202)
🇨🇿Nova Ves pod Plesi, Pribram, Czechia
Fakultni nemocnice v Motole ( Site 2210)
🇨🇿Praha, Praha, Hlavni Mesto, Czechia
H.I.A. Sainte-Anne ( Site 0815)
🇫🇷Toulon, Var, France
Hopital Avicenne ( Site 0803)
🇫🇷Bobigny, Seine-Saint-Denis, France
Clinique Clairval ( Site 0802)
🇫🇷Marseille, Bouches-du-Rhone, France
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2302)
🇭🇺Kecskemét, Bacs-Kiskun, Hungary
Kansai Medical University Hospital ( Site 3103)
🇯🇵Hirakata, Osaka, Japan
Johannes Wesling Klinikum Minden ( Site 0908)
🇩🇪Minden, Nordrhein-Westfalen, Germany
LungenClinic Grosshansdorf GmbH ( Site 0901)
🇩🇪Grosshansdorf, Schleswig-Holstein, Germany
Katholisches Marienkrankenhaus gGmbH ( Site 0902)
🇩🇪Hamburg, Germany
Kurume University Hospital ( Site 3112)
🇯🇵Kurume, Fukuoka, Japan
Kanagawa Cancer Center ( Site 3101)
🇯🇵Yokohama, Kanagawa, Japan
Policlinico Agostino Gemelli ( Site 1002)
🇮🇹Roma, Italy
Kobe Minimally Invasive Cancer Center ( Site 3100)
🇯🇵Kobe, Hyogo, Japan
Tokyo Metropolitan Komagome Hospital ( Site 3108)
🇯🇵Tokyo, Japan
Severance Hospital Yonsei University Health System ( Site 2808)
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital ( Site 2801)
🇰🇷Seongnam-si, Kyonggi-do, Korea, Republic of
Osaka International Cancer Institute ( Site 3106)
🇯🇵Osaka, Japan
Gyeongsang National University Hospital ( Site 2804)
🇰🇷Jinju-si, Kyongsangnam-do, Korea, Republic of
Clinica San Gabriel ( Site 0601)
🇵🇪Lima, Peru
Institutul Regional de Oncologie Iasi ( Site 2505)
🇷🇴Iasi, Romania
Kangbuk Samsung Hospital ( Site 2806)
🇰🇷Seoul, Korea, Republic of
Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 4201)
🇱🇹Kaunas, Kauno Apskritis, Lithuania
Ankara Bilkent Sehir Hastanesi ( Site 2002)
🇹🇷Ankara, Adana, Turkey
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1905)
🇷🇺Saint-Petersburg, Sankt-Peterburg, Russian Federation
H.U. Vall de Hebron ( Site 1201)
🇪🇸Barcelona, Spain
LLC Ukrainian Center of Tomotherapy ( Site 2105)
🇺🇦Kropyvnytskyi, Kirovohradska Oblast, Ukraine
H.R.U Málaga - Hospital General ( Site 1206)
🇪🇸Málaga, Malaga, Spain
Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1202)
🇪🇸Majadahonda, Madrid, Spain
Hospital Universitario Quiron Madrid ( Site 1200)
🇪🇸Pozuelo de Alarcon, Madrid, Spain
Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (
🇺🇦Antonivka Village, Khersonska Oblast, Ukraine
Christie NHS Foundation Trust ( Site 1409)
🇬🇧Manchester, United Kingdom
Medipol Universite Hastanesi ( Site 2003)
🇹🇷Istanbul, Turkey
Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107)
🇺🇦Dnipro, Dnipropetrovska Oblast, Ukraine
Hospital Clinic de Barcelona ( Site 1204)
🇪🇸Barcelona, Spain
Memorial Ankara Hastanesi ( Site 2006)
🇹🇷Ankara, Turkey
Hospital Universitario Virgen Macarena ( Site 1205)
🇪🇸Sevilla, Spain
SNPE National Cancer Institute ( Site 2101)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2001)
🇹🇷Istanbul, Turkey
Leeds Teaching Hospitals NHS Trust ( Site 1401)
🇬🇧Leeds, United Kingdom
Azienda Ospedaliera Vito Fazzi ( Site 1003)
🇮🇹Lecce, Italy
Policlinico di Modena ( Site 1007)
🇮🇹Modena, Italy
A.O.U. Santa Maria della Misericordia di Udine ( Site 1004)
🇮🇹Udine, Italy
Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 2000)
🇹🇷Istanbul, Turkey
Ege University Medical Faculty ( Site 2005)
🇹🇷Izmir, Turkey
University College Hospital NHS Foundation Trust ( Site 1403)
🇬🇧London-Camden, London, City Of, United Kingdom
Guys and St Thomas NHS Foundation Trust ( Site 1410)
🇬🇧London, London, City Of, United Kingdom
Johanna Etienne Hospital-Klinik für Onkologie ( Site 0916)
🇩🇪Neuss, Nordrhein-Westfalen, Germany
Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 0900)
🇩🇪Berlin, Germany
Fox Chase Cancer Center ( Site 0063)
🇺🇸Philadelphia, Pennsylvania, United States
Fort Wayne Medical Oncology and Hematology ( Site 0094)
🇺🇸Fort Wayne, Indiana, United States
VA St. Louis Health Care System ( Site 0047)
🇺🇸Saint Louis, Missouri, United States
Washington University Siteman Cancer Center ( Site 0046)
🇺🇸Saint Louis, Missouri, United States
Bradfordhill ( Site 0200)
🇨🇱Santiago, Region M. De Santiago, Chile
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0102)
🇨🇦Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
🇨🇦Quebec, Canada
The First Affiliated Hospital of Xiamen University ( Site 3219)
🇨🇳Xiamen, Fujian, China
Cancer Hospital Chinese Academy of Medical Sciences ( Site 3213)
🇨🇳Beijing, Beijing, China
Wuhan Union Hospital ( Site 3222)
🇨🇳Wuhan, Hubei, China
The Second Affiliated Hospital of Nanchang University ( Site 3206)
🇨🇳Nanchang, Jiangxi, China
Jilin Cancer Hospital ( Site 3230)
🇨🇳Changchun, Jilin, China
Fakultni nemocnice Ostrava ( Site 2201)
🇨🇿Ostrava, Ostrava Mesto, Czechia
Nemocnice Na Bulovce ( Site 2205)
🇨🇿Praha 8, Czechia
Hospital Universitario La Fe ( Site 1203)
🇪🇸Valencia, Spain
Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2309)
🇭🇺Budapest, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 2306)
🇭🇺Gyor, Gyor-Moson-Sopron, Hungary
Universitaetsklinikum Jena ( Site 0911)
🇩🇪Jena, Thuringen, Germany
Azienda Ospedaliera Umberto I- Torrette ( Site 1009)
🇮🇹Torrette, Ancona, Italy
Azienda Ospedaliero Universitaria Careggi ( Site 1001)
🇮🇹Florence, Firenze, Italy
Istituto Clinico Humanitas Research Hospital ( Site 1000)
🇮🇹Rozzano, Lombardia, Italy
Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2303)
🇭🇺Gyula, Bekes, Hungary
Zentralklinik Bad Berka GmbH ( Site 0905)
🇩🇪Bad Berka, Thuringen, Germany
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1008)
🇮🇹Milano, Italy
The Catholic University of Korea St. Vincent s Hospital ( Site 2805)
🇰🇷Gyeonggi-do, Kyonggi-do, Korea, Republic of
Juntendo University Hospital ( Site 3111)
🇯🇵Tokyo, Japan
Keimyung University Dongsan Hospital ( Site 2807)
🇰🇷Daegu, Taegu-Kwangyokshi, Korea, Republic of
Pauls Stradins Clinical University Hospital ( Site 1501)
🇱🇻Riga, Latvia
Ajou University Hospital ( Site 2803)
🇰🇷Suwon-si, Kyonggi-do, Korea, Republic of
Chungbuk National University Hospital ( Site 2802)
🇰🇷Cheongju-si, Chungbuk, Korea, Republic of
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0508)
🇲🇽Monterrey, Nuevo Leon, Mexico
National Cancer Center ( Site 2800)
🇰🇷Goyang-si, Kyonggi-do, Korea, Republic of
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2400)
🇵🇱Gdynia, Pomorskie, Poland
Oncosalud ( Site 0605)
🇵🇪Lima, Muni Metro De Lima, Peru
S C Oncocenter Oncologie Clinica S R L-Medical Oncology ( Site 2509)
🇷🇴Timișoara, Timis, Romania
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1911)
🇷🇺Kazan, Tatarstan, Respublika, Russian Federation
MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1903)
🇷🇺Moscow, Moskva, Russian Federation
Sverdlovsk Regional Oncology Hospital ( Site 1909)
🇷🇺Ekaterinburg, Sverdlovskaya Oblast, Russian Federation
Ramathibodi Hospital. ( Site 3000)
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
Kyiv City Clinical Oncology Center ( Site 2100)
🇺🇦Kyiv, Ukraine
Orlando Health, UF Health Cancer Center Inc ( Site 0092)
🇺🇸Orlando, Florida, United States
Duke University Medical Center ( Site 0050)
🇺🇸Durham, North Carolina, United States
Piedmont Hematology-Oncology Associates ( Site 0080)
🇺🇸Winston-Salem, North Carolina, United States
Norton Brownsboro Hospital-Norton Cancer Institute - Brownsboro ( Site 0035)
🇺🇸Louisville, Kentucky, United States
Henry Ford Hospital ( Site 0045)
🇺🇸Detroit, Michigan, United States
Centro Investigación del Cáncer James Lind ( Site 0202)
🇨🇱Temuco, Araucania, Chile
North Estonia Medical Centre Foundation ( Site 1601)
🇪🇪Tallin, Harjumaa, Estonia
The Cancer Institute Hospital of JFCR ( Site 3107)
🇯🇵Tokyo, Japan
Showa University Hospital ( Site 3105)
🇯🇵Tokyo, Japan
Riga East Clinical University Hospital ( Site 1500)
🇱🇻Riga, Latvia
National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 4200)
🇱🇹Vilnius, Vilniaus Miestas, Lithuania
CLIMERS Clinical Medical Research ( Site 0506)
🇲🇽Orizaba, Veracruz, Mexico
Oslo Universitetssykehus HF. Ulleval ( Site 1100)
🇳🇴Oslo, Norway
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0606)
🇵🇪Lima, Peru
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
🇵🇱Warszawa, Mazowieckie, Poland
S.C. Radiotherapy Center Cluj S.R.L ( Site 2503)
🇷🇴Comuna Floresti, Cluj, Romania
Radiology Therapeutic Center-Oncology ( Site 2502)
🇷🇴Otopeni, Ilfov, Romania
Instituto Médico Río Cuarto ( Site 4003)
🇦🇷Río Cuarto, Cordoba, Argentina
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0108)
🇨🇦Montreal, Quebec, Canada
Oncocentro ( Site 0203)
🇨🇱Vina del Mar, Valparaiso, Chile
Sykehuset Oestfold ( Site 1107)
🇳🇴Gralum, Ostfold, Norway
SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2401)
🇵🇱Olsztyn, Warminsko-mazurskie, Poland
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1913)
🇷🇺Chelyabinsk, Chelyabinskaya Oblast, Russian Federation
Chulalongkorn University ( Site 3003)
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
Chiang Mai University Maharaj Nakorn Chiang Mai Hospital ( Site 3001)
🇹🇭Chiang Mai, Thailand
Srinagarind Hospital. Khon Kaen University ( Site 3002)
🇹🇭Khon Kaen, Thailand
Osaka Medical and Pharmaceutical University Hospital ( Site 3110)
🇯🇵Takatsuki, Osaka, Japan
Niigata Cancer Center Hospital ( Site 3109)
🇯🇵Niigata, Japan
Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0604)
🇵🇪Arequipa, Ariqipa, Peru
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2404)
🇵🇱Siedlce, Mazowieckie, Poland
Policlinica Oncomed SRL ( Site 2504)
🇷🇴Timisoara, Timis, Romania
Rutgers Cancer Institute of New Jersey ( Site 0054)
🇺🇸New Brunswick, New Jersey, United States
Orszagos Koranyi Pulmonologiai Intezet ( Site 2305)
🇭🇺Budapest, Hungary
OrlandiOncologia ( Site 0201)
🇨🇱Santiago, Region M. De Santiago, Chile
Detecta Clínica ( Site 0607)
🇵🇪Surquillo, Muni Metro De Lima, Peru
Spitalul Universitar de Urgenta Bucuresti ( Site 2508)
🇷🇴Bucharest, Bucuresti, Romania
Gral Medical SRL-Medical Oncology ( Site 2511)
🇷🇴București, Bucuresti, Romania
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2506)
🇷🇴Cluj Napoca, Cluj, Romania
Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2510)
🇷🇴Craiova, Dolj, Romania
S.C.Focus Lab Plus S.R.L ( Site 2500)
🇷🇴Bucuresti, Romania
Spitalul Clinic Judetean De Urgenta Constanta ( Site 2501)
🇷🇴Constanta, Romania
Clinica Adventista Belgrano-Oncology ( Site 4002)
🇦🇷Caba, Argentina
Clinique Teissier Groupe ( Site 0808)
🇫🇷Valenciennes, Nord, France
National Hospital Organization Kyushu Cancer Center ( Site 3104)
🇯🇵Fukuoka, Japan
Instituto Nacional de Cancerologia ( Site 0502)
🇲🇽Tlalpan, Mexico
Akershus Universitetssykehus HF ( Site 1106)
🇳🇴Lorenskog, Akershus, Norway
Vestre Viken HF Drammen Sykehus ( Site 1101)
🇳🇴Drammen, Buskerud, Norway
Hospital Nacional Cayetano Heredia ( Site 0602)
🇵🇪Lima, Peru
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1910)
🇷🇺Yaroslavl, Yaroslavskaya Oblast, Russian Federation
Helse Stavanger HF Stavanger Universitetssjukehus ( Site 1103)
🇳🇴Stavanger, Rogaland, Norway
Nizhniy Novgorod Region Oncology Dispensary ( Site 1914)
🇷🇺Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation
Medical institute named after Berezin Sergey ( Site 1906)
🇷🇺St. Petersburg, Sankt-Peterburg, Russian Federation
Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104)
🇺🇦Kapitanivka Village, Kyivska Oblast, Ukraine
Medical Center Verum ( Site 2106)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Weston Park Hospital ( Site 1406)
🇬🇧Sheffield, Derbyshire, United Kingdom
Royal Marsden Hospital (Sutton) ( Site 1407)
🇬🇧London, Surrey, United Kingdom
Southampton General Hospital ( Site 1400)
🇬🇧Southampton, Worcestershire, United Kingdom
SOGrigoriev Inst for Med Radiolgy and Oncology of NAMS of Ukraine-Clinical oncology and hematology (
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
CHI Health St. Francis ( Site 0053)
🇺🇸Grand Island, Nebraska, United States
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0500)
🇲🇽Guadalajara, Jalisco, Mexico