Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)
- Conditions
- Lung NeoplasmsNon-Small-Cell Lung Carcinoma
- Interventions
- Registration Number
- NCT04738487
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Researchers are looking for new ways to treat people with metastatic non-small cell lung cancer (NSCLC) that is PD-L1 positive.
* Metastatic means cancer that has spread to other parts of the body.
* PD-L1 positive means that PD-L1 is found on the cancer cells. PD-L1 is a protein that can help the cancer hide from the body's immune system.
The goal of this study is to learn if people who receive vibostolimab and pembrolizumab live longer overall and without the cancer getting worse than people who receive pembrolizumab alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1264
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Has a histologically or cytologically confirmed diagnosis of Stage IV: M1a, M1b, or M1c non-small cell lung cancer (NSCLC) per the American Joint Committee on Cancer (AJCC) Staging Manual, version 8
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Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the local site assessment
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Has confirmation that epidermal growth factor receptor (EGFR)-, anaplastic lymphoma kinase (ALK)-, or reactive oxygen species proto-oncogene 1 (ROS1)-directed therapy is not indicated as primary therapy and absence of ALK and ROS1 gene rearrangements
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Has provided tumor tissue that demonstrates Programmed Cell Death 1 Ligand 1 (PD-L1) expression in ≥1% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
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Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 assessed within 7 days prior to randomization
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Has a life expectancy of at least 3 months
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A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP)
- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days after the last dose of study intervention
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Has adequate organ function
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Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy
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Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC.
- Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 6 months before the diagnosis of metastatic NSCLC.
- Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.
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Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137)
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Has received previous treatment with another agent targeting the T cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibition motif (ITIM) domains (TIGIT) receptor pathway
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Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
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Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines is allowed.
- Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed in the study as long as they are mRNA vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy.
- Investigational vaccines (i.e., those not licensed or approved for Emergency Use) are not allowed.
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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
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Has known active or untreated CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks by repeat imaging, clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention
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Has severe hypersensitivity (≥Grade 3) to pembrolizumab/vibostolimab or pembrolizumab and/or any of its excipients
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Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
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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 to the first dose of study intervention
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Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
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Has a known history of interstitial lung disease. Lymphangitic spread of the NSCLC is not exclusionary.
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Has an active infection requiring systemic therapy
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Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority
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Has a known history of Hepatitis B or known active Hepatitis C virus infection
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Has a history or current evidence of any condition, therapy, or laboratory abnormality that prevents the participant from receiving platinum-doublet chemotherapy for first line NSCLC, or that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
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Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab/Vibostolimab Pembrolizumab/Vibostolimab Participants will receive pembrolizumab/vibostolimab as a coformulation (MK-7684A). Pembrolizumab Pembrolizumab Participants will receive pembrolizumab (MK-3475) alone.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% Up to ~68 months OS is defined as the time from randomization to death due to any cause.
- Secondary Outcome Measures
Name Time Method OS in Participants With PD-L1 TPS ≥1% Up to ~68 months OS is defined as the time from randomization to death due to any cause.
OS in Participants With PD-L1 TPS 1% to 49% Up to ~68 months OS is defined as the time from randomization to death due to any cause.
Progression-Free Survival (PFS) in Participants With PD-L1 TPS ≥1% Up to ~54 months PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented.
PFS in Participants With PD-L1 TPS ≥50% Up to ~54 months PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented.
PFS in Participants With PD-L1 TPS 1% to 49% Up to ~54 months PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented.
Objective Response Rate (ORR) in Participants With PD-L1 TPS ≥1% Up to ~54 months ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.
ORR in Participants With PD-L1 TPS ≥50% Up to ~54 months ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.
ORR in Participants With PD-L1 TPS 1% to 49% Up to ~54 months ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.
Duration of Response (DOR) in Participants With PD-L1 TPS ≥50% Up to ~54 months For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented.
DOR in Participants With PD-L1 TPS 1% to 49% Up to ~54 months For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented.
DOR in Participants With PD-L1 TPS ≥1% Up to ~54 months For participants who demonstrate a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by blinded independent central review will be presented.
Change from Baseline in Global Health Status/Quality of Life (QoL) (Items 29, 30) Combined Score on the European Organization for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30) in Participants With PD-L1 TPS ≥50% Baseline and up to ~109 weeks Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("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). A higher score indicates a better overall outcome.
Change from Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% Baseline and up to ~109 weeks Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("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). A higher score indicates a better overall outcome.
Change from Baseline in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% Baseline and up to ~109 weeks Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("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). A higher score indicates a better overall outcome.
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% Baseline and up to ~109 weeks Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% Baseline and up to ~109 weeks Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% Baseline and up to ~109 weeks Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Change from Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% Baseline and up to ~109 weeks Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Change from Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% Baseline and up to ~109 weeks Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Change from Baseline in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% Baseline and up to ~109 weeks Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% Baseline and up to ~109 weeks Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.
Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% Baseline and up to ~109 weeks Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.
Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% Baseline and up to ~109 weeks Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.
Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) in Participants With PD-L1 TPS ≥50% Baseline and up to ~109 weeks Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing
Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% Baseline and up to ~109 weeks Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.
Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1% Baseline and up to ~109 weeks Change from baseline in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50% Baseline and up to ~109 weeks Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% Baseline and up to ~109 weeks Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1% Baseline and up to ~109 weeks Change from baseline in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain.
Time to Deterioration (TTD) in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% Baseline and up to ~109 weeks TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("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). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% Baseline and up to ~109 weeks TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("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). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Global Health Status/QoL (Items 29, 30) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% Baseline and up to ~109 weeks TTD in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("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). A higher score indicates a better overall outcome. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% Baseline and up to ~109 weeks TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% to 49% Baseline and up to ~109 weeks TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% Baseline and up to ~109 weeks TTD in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% Baseline and up to ~109 weeks TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% Baseline and up to ~109 weeks TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Role Functioning (Items 6, 7) Combined Score on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% Baseline and up to ~109 weeks TTD in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥50% Baseline and up to ~109 weeks TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS 1% to 49% Baseline and up to ~109 weeks TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30 in Participants With PD-L1 TPS ≥1% Baseline and up to ~109 weeks TTD in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50% Baseline and up to ~109 weeks TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% Baseline and up to ~109 weeks TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in Cough Score (Item 31) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1% Baseline and up to ~109 weeks TTD in the score of EORTC QLQ-LC13 Item 31 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥50% Baseline and up to ~109 weeks TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS 1% to 49% Baseline and up to ~109 weeks TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 in Participants With PD-L1 TPS ≥1% Baseline and up to ~109 weeks TTD in the score of EORTC QLQ-LC13 Item 40 will be presented. The EORTC QLQ-LC13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is defined as the time to first onset of 10 or more (out of 100) deterioration from baseline and confirmed by a second adjacent 10 or more deterioration from baseline.
Number of Participants Who Experienced One or More Adverse Events (AEs) Up to ~117 weeks The number of participants who experienced an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE) Up to ~105 weeks The number of participants who discontinue study intervention due to an adverse event (AE) will be presented. An AE is defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
Trial Locations
- Locations (188)
Boca Raton Regional Hospital ( Site 0004)
🇺🇸Boca Raton, Florida, United States
Illinois Cancer Care ( Site 0026)
🇺🇸Peoria, Illinois, United States
Mercy Research - David C. Pratt Cancer Center ( Site 0025)
🇺🇸Saint Louis, Missouri, United States
Mercy Research - Cancer and Hematology Center ( Site 0032)
🇺🇸Springfield, Missouri, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0022)
🇺🇸Mineola, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0013)
🇺🇸New York, New York, United States
Fox Chase Cancer Center-Hematology/Oncology ( Site 0030)
🇺🇸Philadelphia, Pennsylvania, United States
Hospital São Carlos-Oncocentro Ce ( Site 0208)
🇧🇷Fortaleza, Ceara, Brazil
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0201)
🇧🇷Natal, Rio Grande Do Norte, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206)
🇧🇷Ijui, Rio Grande Do Sul, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro de Pesquisa Novos Tratamentos em Cân
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0209)
🇧🇷Florianópolis, Santa Catarina, Brazil
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA ( Site 0204)
🇧🇷Rio de Janeiro, Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica ( Site 0200)
🇧🇷Sao Paulo, Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0207)
🇧🇷Sao Paulo, Brazil
BC Cancer Victoria-Clinical Trials Unit ( Site 0107)
🇨🇦Victoria, British Columbia, Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0104)
🇨🇦Hamilton, Ontario, Canada
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0102)
🇨🇦Kingston, Ontario, Canada
Lakeridge Health ( Site 0106)
🇨🇦Oshawa, Ontario, Canada
Centre Intégré de Santé et de Services Sociaux (CISSS) de La-Centre intégré de cancérologie de Lava
🇨🇦Laval, Quebec, Canada
James Lind Centro de Investigacion del Cancer ( Site 0711)
🇨🇱Temuco, Araucania, Chile
CIDO SpA-Oncology ( Site 0707)
🇨🇱Temuco, Araucania, Chile
IC La Serena Research ( Site 0710)
🇨🇱La Serena, Coquimbo, Chile
Clínica Puerto Montt ( Site 0713)
🇨🇱Puerto Montt, Los Lagos, Chile
Oncocentro Valdivia ( Site 0715)
🇨🇱Valdivia, Los Rios, Chile
Clinica Universidad Catolica del Maule-Oncology ( Site 0703)
🇨🇱Talca, Maule, Chile
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0712)
🇨🇱Santiago, Region M. De Santiago, Chile
Orlandi Oncologia ( Site 0700)
🇨🇱Santiago, Region M. De Santiago, Chile
FALP ( Site 0702)
🇨🇱Santiago, Region M. De Santiago, Chile
Bradfordhill ( Site 0701)
🇨🇱Santiago, Region M. De Santiago, Chile
Bradford Hill Norte ( Site 0708)
🇨🇱Antofagasta, Chile
The First Affiliated Hospital of Anhui Medical University ( Site 2022)
🇨🇳Hefei, Anhui, China
Anhui Provincil Hospital South District-Respiratory Medicine Dept ( Site 2017)
🇨🇳Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Science-Oncology ( Site 2030)
🇨🇳Beijing, Beijing, China
Beijing Cancer hospital-intrathoratic deparmtment II ( Site 2001)
🇨🇳Beijing, Beijing, China
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2003)
🇨🇳Beijing, Beijing, China
Beijing Peking Union Medical College Hospital-pneumology department ( Site 2009)
🇨🇳Beijing, Beijing, China
Beijing Chest Hospital,Capital Medical University ( Site 2020)
🇨🇳Beijing, Beijing, China
Chongqing Cancer Hospital-Medical Oncology ( Site 2028)
🇨🇳Chongqing, Chongqing, China
Army Medical Center of People's Liberation Army-respiratory ( Site 2025)
🇨🇳Chongqing, Chongqing, China
Fujian Provincial Cancer Hospital-oncology department ( Site 2023)
🇨🇳Fuzhou, Fujian, China
Fuzhou General hospital of Nanjing Military Command-Oncology Department ( Site 2029)
🇨🇳Fuzhou, Fujian, China
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (
🇨🇳Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital ( Site 2006)
🇨🇳Harbin, Heilongjiang, China
Henan Cancer Hospital ( Site 2015)
🇨🇳Zhengzhou, Henan, China
Wuhan Union Hospital-Medical Oncology ( Site 2019)
🇨🇳Wuhan, Hubei, China
Xiangya Hospital Central South University-Respiratory -Asthma&COPD ( Site 2026)
🇨🇳Changsha, Hunan, China
Hunan Cancer Hospital-thoracic oncology II ( Site 2013)
🇨🇳Changsha, Hunan, China
Northern Jiangsu People's Hospital-General Surgery Department ( Site 2016)
🇨🇳Yangzhou, Jiangsu, China
Jilin Cancer Hospital-oncology department ( Site 2000)
🇨🇳Changchun, Jilin, China
Tang Du Hospital ( Site 2004)
🇨🇳Xi'an, Shaanxi, China
The First Affiliated Hospital of Xian Jiaotong University wa-Oncology ( Site 2012)
🇨🇳Xi'an, Shaanxi, China
LinYi Cancer Hospital ( Site 2034)
🇨🇳Linyi, Shandong, China
Linyi People's Hospital-Oncology ( Site 2035)
🇨🇳Linyi, Shandong, China
Fudan University Shanghai Cancer Center ( Site 2032)
🇨🇳Shanghai, Shanghai, China
West China Hospital Sichuan University-respiratory ( Site 2018)
🇨🇳Cheng Du, Sichuan, China
Hangzhou Cancer Hospital-Medical Oncology ( Site 2039)
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital-Breast Oncology ( Site 2008)
🇨🇳Hangzhou, Zhejiang, China
The Second Affiliated hospital of Zhejiang University school of medicine-Respiratory Medicine ( Site
🇨🇳Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province-Respiratory ( Site 2027)
🇨🇳Linhai, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 2031)
🇨🇳Wenzhou, Zhejiang, China
Instituto de Oncologia ( Site 2300)
🇩🇴Santo Domingo, Distrito Nacional, Dominican Republic
CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 2301)
🇩🇴Santo Domingo, Distrito Nacional, Dominican Republic
Onco Go, S.A ( Site 0306)
🇬🇹Guatemala City, Guatemala
CELAN,S.A ( Site 0304)
🇬🇹Guatemala, Guatemala
Gastrosoluciones ( Site 0302)
🇬🇹Guatemala, Guatemala
INTEGRA Cancer Institute ( Site 0303)
🇬🇹Guatemala, Guatemala
Oncomedica-Guatemala ( Site 0301)
🇬🇹Guatemala, Guatemala
Grupo Medico Angeles ( Site 3007)
🇬🇹Guatemala, Guatemala
Hong Kong Integrated Oncology Centre ( Site 1301)
🇭🇰Central, Hong Kong
Queen Mary Hospital ( Site 1303)
🇭🇰Hksar, Hong Kong
Hong Kong United Oncology Centre ( Site 1302)
🇭🇰Jordan, Hong Kong
Princess Margaret Hospital ( Site 1304)
🇭🇰Lai Chi Kok, Hong Kong
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1201)
🇭🇺Kecskemét, Bacs-Kiskun, Hungary
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház-Megyei Onkológiai Centrum ( Site 1207)
🇭🇺Gyula, Bekes, Hungary
Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia ( Site 1205)
🇭🇺Gyor, Gyor-Moson-Sopron, Hungary
Mátrai Gyógyintézet ( Site 1214)
🇭🇺Kékestető, Heves, Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 1200)
🇭🇺Szolnok, Jasz-Nagykun-Szolnok, Hungary
Országos Korányi Pulmonológiai Intézet-XIV. Tüdöbelgyógyászat ( Site 1204)
🇭🇺Budapest, Pest, Hungary
Reformatus Pulmonologiai Centrum-Onkopulmonologiai Jarobeteg Centrum ( Site 1208)
🇭🇺Torokbalint, Pest, Hungary
Zala Megyei Szent Rafael Kórház-Pulmonológia ( Site 1202)
🇭🇺Zalaegerszeg, Zala, Hungary
Semmelweis University-Pulmonológiai Klinika ( Site 1209)
🇭🇺Budapest, Hungary
All India Institute of Medical Sciences ( Site 2403)
🇮🇳New Delhi, Delhi, India
Rajiv Gandhi Cancer Institute And Research Centre ( Site 2400)
🇮🇳New Delhi, Delhi, India
Artemis hospital ( Site 2401)
🇮🇳Gurugram, Haryana, India
Tata Memorial Hospital-Medical Oncology ( Site 2404)
🇮🇳Mumbai, Maharashtra, India
National Hospital Organization Nagoya Medical Center ( Site 1920)
🇯🇵Nagoya, Aichi, Japan
Fujita Health University ( Site 1906)
🇯🇵Toyoake, Aichi, Japan
Ehime University Hospital ( Site 1911)
🇯🇵Toon, Ehime, Japan
Kurume University Hospital ( Site 1912)
🇯🇵Kurume, Fukuoka, Japan
Gunma Prefectural Cancer Center ( Site 1925)
🇯🇵Otashi, Gunma, Japan
National Hospital Organization Hokkaido Cancer Center ( Site 1923)
🇯🇵Sapporo, Hokkaido, Japan
Hyogo College of Medicine-Respiratory Medicine and Hematology ( Site 1922)
🇯🇵Nishinomiya, Hyogo, Japan
Takarazuka City Hospital ( Site 1924)
🇯🇵Takarazuka, Hyogo, Japan
Kanagawa Cardiovascular and Respiratory Center ( Site 1921)
🇯🇵Yokohama, Kanagawa, Japan
Kanagawa cancer center ( Site 1916)
🇯🇵Yokohama, Kanagawa, Japan
Sendai Kousei Hospital ( Site 1900)
🇯🇵Sendai, Miyagi, Japan
Niigata Cancer Center Hospital ( Site 1904)
🇯🇵Niigata-shi, Niigata, Japan
Kansai Medical University Hospital ( Site 1914)
🇯🇵Hirakata, Osaka, Japan
Kindai University Hospital- Osakasayama Campus ( Site 1907)
🇯🇵Osaka-sayama, Osaka, Japan
National Hospital Organization Kinki-chuo Chest Medical Center-Department of Thoracic Oncology ( Sit
🇯🇵Sakai, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 1908)
🇯🇵Takatsuki, Osaka, Japan
Shizuoka Cancer Center ( Site 1905)
🇯🇵Nagaizumi, Shizuoka, Japan
Tochigi Cancer Center ( Site 1927)
🇯🇵Utsunomiya, Tochigi, Japan
Chiba University Hospital-Medical Oncology ( Site 1926)
🇯🇵Chiba, Japan
Okayama University Hospital ( Site 1913)
🇯🇵Okayama, Japan
Osaka International Cancer Institute ( Site 1915)
🇯🇵Osaka, Japan
Tokushima University Hospital ( Site 1917)
🇯🇵Tokushima, Japan
Juntendo University Hospital ( Site 1902)
🇯🇵Tokyo, Japan
Japanese Foundation for Cancer Research ( Site 1901)
🇯🇵Tokyo, Japan
Wakayama Medical University Hospital ( Site 1910)
🇯🇵Wakayama, Japan
Chungbuk National University Hospital-Internal medicine ( Site 1406)
🇰🇷Cheongju-si, Chungbuk, Korea, Republic of
National Cancer Center-Lung Cancer Center ( Site 1407)
🇰🇷Goyang-si, Kyonggi-do, Korea, Republic of
Seoul National University Bundang Hospital ( Site 1403)
🇰🇷Seongnam, Kyonggi-do, Korea, Republic of
The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 1405)
🇰🇷Suwon-si, Kyonggi-do, Korea, Republic of
Seoul National University Hospital ( Site 1401)
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital ( Site 1409)
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Eunpyeong St. Mary's Hospital-Cancer center ( Site 1410)
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System ( Site 1402)
🇰🇷Seoul, Korea, Republic of
Asan Medical Center ( Site 1400)
🇰🇷Seoul, Korea, Republic of
The Catholic Univ. of Korea Seoul St. Mary's Hospital-Medical Oncology ( Site 1408)
🇰🇷Seoul, Korea, Republic of
University Malaya Medical Centre ( Site 1504)
🇲🇾Lembah Pantai, Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan ( Site 1502)
🇲🇾Kuantan, Pahang, Malaysia
Gleneagles Penang Medical Center-Clinical Research Center (CRC) ( Site 1503)
🇲🇾George Town, Pulau Pinang, Malaysia
Hospital Pulau Pinang ( Site 1501)
🇲🇾George Town, Pulau Pinang, Malaysia
National Cancer Institute ( Site 1505)
🇲🇾Putrajaya, Wilayah Persekutuan Putrajaya, Malaysia
Arké SMO S.A. de C.V. ( Site 0417)
🇲🇽Mexico, Distrito Federal, Mexico
Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0411)
🇲🇽Guadalajara, Jalisco, Mexico
Centro de Investigacion Clinica Chapultepec ( Site 0400)
🇲🇽Morelia, Michoacan, Mexico
iCan Oncology Center Centro Medico AVE ( Site 0405)
🇲🇽Monterrey, Nuevo Leon, Mexico
Hospital H+ Queretaro ( Site 0416)
🇲🇽Santiago de Queretaro, Queretaro, Mexico
Medical Care and Research SA de CV ( Site 0409)
🇲🇽Merida, Yucatan, Mexico
Centro Oncologico de Chihuahua-Unidad de Investigacion Clinica ( Site 0402)
🇲🇽Chihuahua, Mexico
Human Science Research Trials ( Site 0406)
🇲🇽Mexico city, Mexico
Oaxaca Site Management Organization ( Site 0403)
🇲🇽Oaxaca, Mexico
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0507)
🇵🇪San isidro, Lima, Peru
UNIDAD DE ONCOLOGIA HOSPITAL NACIONAL ADOLFO GUEVARA VELASCO ESSSALUD CUSCO ( Site 0504)
🇵🇪Cusco, Qusqu, Peru
Hospital Guillermo Almenara Irigoyen-Oncology ( Site 0508)
🇵🇪Lima, Peru
Clínica Internacional - Sede San Borja ( Site 0506)
🇵🇪Lima, Peru
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 0500)
🇵🇪Lima, Peru
Hospital Militar Central Luis Arias Schereiber ( Site 0502)
🇵🇪Lima, Peru
East Avenue Medical Center-Department of Medicine ( Site 1605)
🇵🇭Quezon City, National Capital Region, Philippines
Veterans Memorial Medical Center-Section of Oncology ( Site 1608)
🇵🇭Quezon City, National Capital Region, Philippines
CARDINAL SANTOS MEDICAL CENTER ( Site 1606)
🇵🇭San Juan City, Metro Manila, National Capital Region, Philippines
Cardiomed SRL Cluj-Napoca ( Site 2201)
🇷🇴Cluj-Napoca, Cluj, Romania
Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2202)
🇷🇴Craiova, Dolj, Romania
SC Medical Center Gral SRL ( Site 2203)
🇷🇴Ploiesti, Prahova, Romania
Moscow Regional Oncological Dispensary ( Site 0812)
🇷🇺Balashikha, Moskovskaya Oblast, Russian Federation
Hadassah Medical-Oncology department ( Site 0814)
🇷🇺Moscow, Moskovskaya Oblast, Russian Federation
Central Clinical Hospital of the Presidential Administrative Department ( Site 0802)
🇷🇺Moscow, Moskva, Russian Federation
Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 0809)
🇷🇺Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation
GBUZ LOKB-Oncology department #1 ( Site 0804)
🇷🇺Saint-Petersburg, Sankt-Peterburg, Russian Federation
Republican Clinical Oncology Dispensary ( Site 0805)
🇷🇺Kazan, Tatarstan, Respublika, Russian Federation
Scientific research institution of oncology named after N.N. Petrov-Thoracic oncology ( Site 0803)
🇷🇺Sankt-Peterburg, Russian Federation
Wits Clinical Research ( Site 0900)
🇿🇦Johannesburg, Gauteng, South Africa
Medical Oncology Centre of Rosebank ( Site 0906)
🇿🇦Johannesburg, Gauteng, South Africa
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0901)
🇿🇦Pretoria, Gauteng, South Africa
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0902)
🇿🇦Sandton, Gauteng, South Africa
Wits Clinical Research-Wits Clinical Research Bara ( Site 0908)
🇿🇦Soweto, Gauteng, South Africa
The Oncology Centre ( Site 0905)
🇿🇦Durban, Kwazulu-Natal, South Africa
Abraham Oncology ( Site 0907)
🇿🇦Richards Bay, Kwazulu-Natal, South Africa
Cape Town Oncology Trials ( Site 0903)
🇿🇦Cape Town, Western Cape, South Africa
Chulalongkorn University ( Site 1802)
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
Ramathibodi Clinical Research Centre ( Site 1801)
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
Faculty of Medicine Siriraj Hospital ( Site 1800)
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
Erciyes University Medical Oncology Department ( Site 1007)
🇹🇷Talas, Kayseri, Turkey
Hacettepe Universitesi-oncology hospital ( Site 1001)
🇹🇷Ankara, Turkey
Memorial Ankara Hastanesi-Medical Oncology ( Site 1002)
🇹🇷Ankara, Turkey
Gazi Universitesi-Oncology ( Site 1003)
🇹🇷Ankara, Turkey
Acıbadem Maslak Hastanesi ( Site 1008)
🇹🇷İstanbul, Turkey
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1000)
🇹🇷Istanbul, Turkey
Samsun Medical Park Hastanesi-medical oncology ( Site 1005)
🇹🇷Samsun, Turkey
Cherkasy Regional Oncology Dispensary ( Site 1110)
🇺🇦Cherkassy, Cherkaska Oblast, Ukraine
Chernihiv Medical Center of Modern Oncology-Clinical oncology and gynecology department ( Site 1113)
🇺🇦Chernihiv, Chernihivska Oblast, Ukraine
Municipal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council ( Site 1100)
🇺🇦Dnipro, Dnipropetrovska Oblast, Ukraine
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional-Chemotherapy department ( Site 1104)
🇺🇦Kryvyi Rih, Dnipropetrovska Oblast, Ukraine
Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regio
🇺🇦Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1119)
🇺🇦Kharkiv, Kharkivska Oblast, Ukraine
National Cancer Institute ( Site 1114)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Vinnytsia Regional Clinical Oncological Hospital ( Site 1102)
🇺🇦Vinnytsia, Vinnytska Oblast, Ukraine
Uzhgorod Central City Clinical Hospital-City oncology center ( Site 1120)
🇺🇦Uzhhorod, Zakarpatska Oblast, Ukraine
Oncolife LLC-day-stay department ( Site 1107)
🇺🇦Zaporizhzhia, Zaporizka Oblast, Ukraine
Zhytomyr Regional Oncology Center-Chemotherapy Department ( Site 1103)
🇺🇦Zhytomyr, Zhytomyrska Oblast, Ukraine
Hanoi Oncology Hospital ( Site 2502)
🇻🇳Hanoi, Ha Noi, Vietnam
K Hospital - National Cancer Hospital ( Site 2506)
🇻🇳Hanoi, Ha Noi, Vietnam
National Lung Hospital-Oncology Department ( Site 2503)
🇻🇳Hanoi, Ha Noi, Vietnam
Ho Chi Minh City Oncology Hospital - Tan Phu Ward ( Site 2505)
🇻🇳Ho Chi Minh, Vietnam
HCMC University Medical Center-Chemotherapy Department ( Site 2501)
🇻🇳Ho Chi Minh, Vietnam