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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05298423
Registration number
NCT05298423
Ethics application status
Date submitted
17/03/2022
Date registered
28/03/2022
Titles & IDs
Public title
Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006)
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Scientific title
Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab With Pembrolizumab) in Combination With Concurrent Chemoradiotherapy Followed by MK-7684A Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III NSCLC
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Secondary ID [1]
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MK-7684A-006
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Secondary ID [2]
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7684A-006
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - pembrolizumab/vibostolimab
Treatment: Other - durvalumab
Treatment: Drugs - cisplatin
Treatment: Drugs - pemetrexed
Treatment: Drugs - etoposide
Treatment: Drugs - carboplatin
Treatment: Drugs - paclitaxel
Treatment: Other - thoracic radiotherapy
Experimental: pembrolizumab/vibostolimab coformulation+chemotherapy+radiotherapy - For the first 3 cycles, participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) intravenously (IV) on Day 1 plus 3 cycles of investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gray \[Gy\] in 2 Gy fractions for 30 days total) during Cycles 2, 3. Participants receive pembrolizumab/vibostolimab for Cycles 4-20 or until discontinuation (up to \~14 months). Cycles 1-20 are 21-day cycles. Investigator's choice of chemotherapy: cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m\^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m\^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m\^2 on Day 1 of Cycle 1 and 45 mg/m\^2 on Days 1, 8, 15 of Cycles 2-3.
Active comparator: chemotherapy+radiotherapy+durvalumab - For the first 3 cycles, participants will receive investigator's choice of platinum doublet chemotherapy and concurrent standard thoracic radiotherapy (60 Gy in 2 Gy fractions for 30 days total) during Cycles 2 and 3. Following concurrent chemoradiotherapy (cCRT), participants receive durvalumab 10 mg/kg every 2 weeks for up to an additional 26 cycles or until discontinuation (up to approximately 14 months). cCRT Cycles 1-3=21-day cycles; durvalumab Cycles 1-26=14-day cycles.
Investigator's choice of chemotherapy: cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of Cycles 1-3 for non-squamous histology only; cisplatin 50 mg/m\^2 on Days 1, 8 of Cycles 1-2 and Days 8, 15 of Cycle 3 and etoposide 50 mg/m\^2 on Days 1-5 of Cycles 1-2 and Days 8-12 of Cycle 3; carboplatin area under the curve (AUC) 6 mg/ml/min on Day 1 of Cycle 1 and AUC 2 mg/ml/min on Days 1, 8, 15 of Cycles 2-3 and paclitaxel 200 mg/m\^2 on Day 1 of Cycle 1 and 45 mg/m\^2 on Days 1, 8, 15 of Cycles 2-3.
Treatment: Other: pembrolizumab/vibostolimab
Administered as an intravenous (IV) infusion
Treatment: Other: durvalumab
Administered as an IV infusion
Treatment: Drugs: cisplatin
Administered as an IV infusion
Treatment: Drugs: pemetrexed
Administered as an IV infusion
Treatment: Drugs: etoposide
Administered as an IV infusion
Treatment: Drugs: carboplatin
Administered as an IV infusion
Treatment: Drugs: paclitaxel
Administered as an IV infusion
Treatment: Other: thoracic radiotherapy
Administered as an external beam radiation
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS) For All Participants
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Assessment method [1]
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PFS is defined as the time from randomization to the first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. 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 =5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. PFS per RECIST 1.1 will be assessed by blinded independent central review (BICR).
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Timepoint [1]
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Up to approximately 55 months
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Primary outcome [2]
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Progression-Free Survival (PFS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) =1%
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Assessment method [2]
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PFS is defined as the time from randomization to the first documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. 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 =5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. PFS per RECIST 1.1 will be assessed by blinded independent central review (BICR).
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Timepoint [2]
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Up to approximately 55 months
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Primary outcome [3]
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Overall Survival (OS) For All Participants
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Assessment method [3]
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OS is defined as the time from randomization to death due to any cause.
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Timepoint [3]
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Up to approximately 75 months
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Primary outcome [4]
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Overall Survival (OS) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) =1%
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Assessment method [4]
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OS is defined as the time from randomization to death due to any cause.
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Timepoint [4]
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Up to approximately 75 months
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Secondary outcome [1]
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Objective Response Rate (ORR) For All Participants
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Assessment method [1]
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ORR is defined as the percentage of participants who have a best response of confirmed 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 Version 1.1 (RECIST 1.1). CR or PR by RECIST 1.1 will be assessed by blinded independent central review (BICR).
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Timepoint [1]
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Up to approximately 75 months
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Secondary outcome [2]
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Objective Response Rate (ORR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) =1%
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Assessment method [2]
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ORR is defined as the percentage of participants who have a best response of confirmed 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 Version 1.1 (RECIST 1.1). CR or PR by RECIST 1.1 will be assessed by blinded independent central review (BICR).
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Timepoint [2]
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Up to approximately 75 months
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Secondary outcome [3]
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Number of Participants Who Experience at Least One Adverse Event (AE)
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Assessment method [3]
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An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
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Timepoint [3]
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Up to approximately 75 months
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Secondary outcome [4]
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Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
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Assessment method [4]
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An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
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Timepoint [4]
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Up to approximately 75 months
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Secondary outcome [5]
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Duration of Response (DOR) For All Participants
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Assessment method [5]
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Duration of Response (DOR) is the time from first documented evidence of 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 Version 1.1 (RECIST 1.1) until progressive disease (PD) or death. DOR per RECIST 1.1 will be assessed by blinded independent central review (BICR).
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Timepoint [5]
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Up to approximately 75 months
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Secondary outcome [6]
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Duration of Response (DOR) For Participants With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) =1%
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Assessment method [6]
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Duration of Response (DOR) is the time from first documented evidence of 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 Version 1.1 (RECIST 1.1) until progressive disease (PD) or death. DOR per RECIST 1.1 will be assessed by blinded independent central review (BICR).
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Timepoint [6]
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Up to approximately 75 months
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Secondary outcome [7]
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Change from Baseline in the Global Health Status /Quality of Life Items 29 and 30 Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) For All Participants
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Assessment method [7]
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The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL 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.
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Timepoint [7]
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0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
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Secondary outcome [8]
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Change from Baseline in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS =1%
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Assessment method [8]
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0
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL 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.
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Timepoint [8]
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0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
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Secondary outcome [9]
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Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants
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Assessment method [9]
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The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a higher score indicating a better quality of life.
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Timepoint [9]
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0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
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Secondary outcome [10]
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0
Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS =1%
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Assessment method [10]
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0
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, with a higher score indicating a better quality of life.
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Timepoint [10]
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0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
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Secondary outcome [11]
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Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) For All Participants
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Assessment method [11]
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0
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing.
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Timepoint [11]
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0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
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Secondary outcome [12]
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Change from Baseline in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS =1%
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Assessment method [12]
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0
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing.
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Timepoint [12]
0
0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
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Secondary outcome [13]
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0
Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants
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Assessment method [13]
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The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain.
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Timepoint [13]
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0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
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Secondary outcome [14]
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Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS =1%
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Assessment method [14]
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0
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain.
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Timepoint [14]
0
0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
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Secondary outcome [15]
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Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants
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Assessment method [15]
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The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea.
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Timepoint [15]
0
0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
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Secondary outcome [16]
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0
Change from Baseline in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS =1%
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Assessment method [16]
0
0
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea.
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Timepoint [16]
0
0
Baseline (at randomization) and at the end of study (approximately 75 months post randomization)
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Secondary outcome [17]
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0
Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For All Participants
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Assessment method [17]
0
0
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL 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 outcome. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline.
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Timepoint [17]
0
0
Up to approximately 75 months post randomization
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Secondary outcome [18]
0
0
Time to True Deterioration (TTD) in the Global Health Status/Quality of Life Items 29 and 30 Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS =1%
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Assessment method [18]
0
0
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. 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 QoL 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 outcome. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline.
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Timepoint [18]
0
0
Up to approximately 75 months post randomization
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Secondary outcome [19]
0
0
Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For All Participants
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Assessment method [19]
0
0
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of function. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline.
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Timepoint [19]
0
0
Up to approximately 75 months post randomization
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Secondary outcome [20]
0
0
Time to True Deterioration (TTD) in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS =1%
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Assessment method [20]
0
0
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life (QoL) of individuals with cancer. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of function. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline.
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Timepoint [20]
0
0
Up to approximately 75 months post randomization
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Secondary outcome [21]
0
0
Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For All Participants
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Assessment method [21]
0
0
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline.
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Timepoint [21]
0
0
Up to approximately 75 months post randomization
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Secondary outcome [22]
0
0
Time to True Deterioration (TTD) in Cough Score (Item 31) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS =1%
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Assessment method [22]
0
0
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you coughed?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more frequent coughing. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline.
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Timepoint [22]
0
0
Up to approximately 75 months post randomization
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Secondary outcome [23]
0
0
Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For All Participants
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Assessment method [23]
0
0
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline.
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Timepoint [23]
0
0
Up to approximately 75 months post randomization
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Secondary outcome [24]
0
0
Time to True Deterioration (TTD) in Chest Pain Score (Item 40) on the EORTC QLQ-LC13 For Participants With PD-L1 TPS =1%
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Assessment method [24]
0
0
The EORTC QLQ-LC13 is a lung cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline.
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Timepoint [24]
0
0
Up to approximately 75 months post randomization
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Secondary outcome [25]
0
0
Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For All Participants
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Assessment method [25]
0
0
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline.
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Timepoint [25]
0
0
Up to approximately 75 months post randomization
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Secondary outcome [26]
0
0
Time to True Deterioration (TTD) in Dyspnea (Item 8) Score on the EORTC QLQ-C30 For Participants With PD-L1 TPS =1%
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Assessment method [26]
0
0
The EORTC QLQ-C30 is a cancer specific health-related quality of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a worse level of dyspnea. TTD is defined as the time to first onset of =10-point deterioration (out of 100) from baseline and confirmed by a second adjacent =10-point deterioration from baseline.
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Timepoint [26]
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0
Up to approximately 75 months post randomization
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Eligibility
Key inclusion criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria
* 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 determined to have unresectable, Stage III NSCLC as documented by a multidisciplinary tumor board or by the treating physician in consultation with a thoracic surgeon
* Has no evidence of metastatic disease, indicating Stage IV NSCLC, in whole-body fluorodeoxyglucose (FDG)-positron emission tomography (PET) or FDG-PET/ computed tomography (CT) and CT or magnetic resonance imaging (MRI) scans of diagnostic quality of chest, abdomen, pelvis and brain
* Has measurable disease as defined by RECIST 1.1, with at least 1 lesion being appropriate for selection as a target lesion, as determined by local site investigator/radiology review
* Has not received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for their Stage III NSCLC
* Has provided 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
* Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements. Mixed squamous/nonsquamous tumors are eligible
* Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer
* Has received major surgery (with the exception of replacement of vascular access) within 4 weeks before randomization. If the participant had a major operation, the participant must have recovered adequately from the procedure and/or any complications from the operation before starting study intervention
* Is expected to require any other form of antineoplastic therapy, while on study
* Has received colony-stimulating factors (e.g., Granulocyte Colony-Stimulating Factor [G-CSF], Granulocyte Macrophage Colony-Stimulating Factor [GM-CSF], or recombinant erythropoietin) within 28 days prior to the first dose of study intervention
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
* Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
* 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 (defined as hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV ribonucleic acid [RNA] qualitative is detected) infection
* Has had an allogenic tissue/solid organ transplant
Pemetrexed-specific Criteria:
* 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 (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed
* Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone
Query!
Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/05/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
4/09/2029
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Actual
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Sample size
Target
784
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,TAS,VIC
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Recruitment hospital [1]
0
0
Canberra Hospital ( Site 0010) - Canberra
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Recruitment hospital [2]
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Icon Cancer Centre Hobart ( Site 0003) - Hobart
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Recruitment hospital [3]
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Ballarat Health Services-Medical Oncology ( Site 0002) - Ballarat Central
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Recruitment hospital [4]
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Frankston Hospital-Oncology and Haematology ( Site 0009) - Frankston
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Recruitment hospital [5]
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St Vincent's Hospital-Oncology Clinical Trials ( Site 0005) - Melbourne
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Recruitment postcode(s) [1]
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2605 - Canberra
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Recruitment postcode(s) [2]
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7000 - Hobart
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Recruitment postcode(s) [3]
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3350 - Ballarat Central
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Recruitment postcode(s) [4]
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3199 - Frankston
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Recruitment postcode(s) [5]
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3065 - Melbourne
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Recruitment outside Australia
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United States of America
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California
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Florida
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United States of America
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Illinois
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Indiana
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Maryland
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Massachusetts
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Missouri
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New York
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Oregon
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Washington
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Brazil
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Rio Grande Do Sul
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Chile
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Araucania
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Chile
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Biobio
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Chile
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Region M. De Santiago
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Chile
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Valparaiso
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China
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Beijing
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China
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Chongqing
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China
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Fujian
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China
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Guangdong
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China
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Hebei
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China
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Henan
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China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
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Jilin
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China
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Shandong
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China
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Shanghai
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China
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Shanxi
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China
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Sichuan
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China
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Tianjin
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China
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Zhejiang
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Costa Rica
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San Jose
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Dominican Republic
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Distrito Nacional
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Dominican Republic
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Santo Domingo
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Berlin
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Attiki
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Greece
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Irakleio
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Greece
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Thessaloniki
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Guatemala
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Ciudad de Guatemala
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Guatemala
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Guatemala
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Guatemala
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Quetzaltenango
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Campania
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Brescia
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
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Niigata
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tokyo
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Korea, Republic of
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Chungbuk
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Seoul
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Malaysia
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Kuala Lumpur
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Malaysia
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Pulau Pinang
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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Chihuahua
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Mexico
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Oaxaca
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Philippines
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National Capital Region
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Portugal
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State/province [77]
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Lisboa
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Portugal
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State/province [78]
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Porto
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Country [79]
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Romania
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State/province [79]
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Bucuresti
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Romania
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Cluj
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Romania
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State/province [81]
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Dolj
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Romania
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State/province [82]
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Ilfov
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Romania
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Timis
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South Africa
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State/province [84]
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Eastern Cape
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South Africa
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Gauteng
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South Africa
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Kwazulu-Natal
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South Africa
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Western Cape
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Spain
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Cataluna
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Spain
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State/province [89]
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La Coruna
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Spain
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State/province [90]
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Madrid, Comunidad De
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Turkey
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State/province [91]
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Istanbul
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Turkey
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Izmir
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Turkey
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Adana
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Turkey
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Ankara
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Ukraine
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Kirovohradska Oblast
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Ukraine
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Lvivska Oblast
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Ukraine
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Rivnenska Oblast
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Ukraine
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Vinnytska Oblast
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Ukraine
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State/province [99]
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Kyiv
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Researchers are looking for new ways to treat people with locally advanced non-small cell lung cancer (NSCLC). The goal of this study is to learn if people who receive the combination of vibostolimab and pembrolizumab (MK-7684A) live longer without the cancer getting worse and live longer overall than people who receive durvalumab.
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Trial website
https://clinicaltrials.gov/study/NCT05298423
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Medical Director
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Address
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0
Merck Sharp & Dohme LLC
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Phone
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Fax
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Email
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Contact person for public queries
Name
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0
Toll Free Number
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Address
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Country
0
0
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Phone
0
0
1-888-577-8839
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05298423