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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03003962
Registration number
NCT03003962
Ethics application status
Date submitted
15/12/2016
Date registered
28/12/2016
Titles & IDs
Public title
Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)
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Scientific title
A Phase III Randomized, Open-Label, Multi-Center Study of Durvalumab (MEDI4736) Versus Standard of Care (SoC) Platinum-Based Chemotherapy as First Line Treatment in Patients With PD-L1-High Expression Advanced Non Small-Cell Lung Cancer
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Secondary ID [1]
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2018-001375-21
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Secondary ID [2]
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D419AC00002
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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:
Non Small Cell Lung Carcinoma NSCLC
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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: Drugs - Durvalumab (MEDI4736)
Treatment: Drugs - Paclitaxel + carboplatin
Treatment: Drugs - Gemcitabine + cisplatin
Treatment: Drugs - Gemcitabine + carboplatin
Treatment: Drugs - Pemetrexed + cisplatin
Treatment: Drugs - Pemetrexed + carboplatin
Experimental: Arm 1: Durvalumab - Anti-PD-L1 monoclonal Antibody monotherapy
Active comparator: Arm 2: Standard of Care - Standard of Care Platinum-Based chemotherapy
Treatment: Drugs: Durvalumab (MEDI4736)
Anti-PD-L1 monoclonal Antibody monotherapy
Treatment: Drugs: Paclitaxel + carboplatin
Chemotherapy Agents
Treatment: Drugs: Gemcitabine + cisplatin
Chemotherapy Agents
Treatment: Drugs: Gemcitabine + carboplatin
Chemotherapy Agents
Treatment: Drugs: Pemetrexed + cisplatin
Chemotherapy Agent
Treatment: Drugs: Pemetrexed + carboplatin
Chemotherapy Agent
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Intervention code [1]
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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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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from the date of randomization until death due to any cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive.
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Timepoint [1]
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From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months [data cut-off (DCO) 27 October 2022]
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Primary outcome [2]
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OS in Participants With LREM
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Assessment method [2]
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OS is defined as the time from the date of randomization until death due to any cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive.
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Timepoint [2]
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0
From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months (DCO 27 October 2022)
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Secondary outcome [1]
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OS in PD-L1 TC >= 50% Analysis Set
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Assessment method [1]
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OS is defined as the time from the date of randomization until death due to any cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive.
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Timepoint [1]
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0
From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months (DCO 27 October 2022)
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Secondary outcome [2]
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OS in PD-L1 TC >= 50% LREM Analysis Set
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Assessment method [2]
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OS is defined as the time from the date of randomization until death due to ay cause (date of death or censoring-date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive.
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Timepoint [2]
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0
From date of randomization until death due to any cause. Assessed up to a maximum of approximately 69 months (DCO 27 October 2022)
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Secondary outcome [3]
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Progression Free Survival (PFS) Based on Investigator Assessment According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
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Assessment method [3]
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The PFS (per RECIST 1.1) was defined as the time from the date of randomization until the date of objective disease progression or death regardless of whether the participants withdrew from randomized therapy or received another anticancer therapy prior to progression (i.e., date of PFS event or censoring - date of randomization +1). Progression of disease per RECIST 1.1, when either 1 of the criteria met: Target lesion (TL): at least a 20% increase in the sum of diameters of TLs, for reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Non-target lesion (NTL): Unequivocal progression of existing NTLs. It may be due to an important progression in 1 lesion only or in several lesions. In all cases the progression must be clinically significant for the physician to consider changing (or stopping) therapy. New lesions: the presence of 1 or more new lesions was assessed as progression.
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Timepoint [3]
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Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months DCO 27 October 2022)
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Secondary outcome [4]
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PFS Based on Investigator Assessment According to RECIST 1.1 in LREM Analysis Set
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Assessment method [4]
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The PFS (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of randomization until the date of objective disease progression or death regardless of whether the participants withdrew from randomized therapy or received another anticancer therapy prior to progression (i.e., date of PFS event or censoring - date of randomization +1).
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Timepoint [4]
0
0
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)
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Secondary outcome [5]
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PFS Based on Investigator Assessment According to RECIST 1.1 in PD-L1 TC >= 50% Analysis Set
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Assessment method [5]
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The PFS (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of randomization until the date of objective disease progression or death regardless of whether the participants withdrew from randomized therapy or received another anticancer therapy prior to progression (i.e., date of PFS event or censoring - date of randomization +1).
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Timepoint [5]
0
0
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)
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Secondary outcome [6]
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PFS Based on Investigator Assessment According to RECIST 1.1 in PD-L1 TC >= 50% LREM Analysis Set
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Assessment method [6]
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The PFS (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of randomization until the date of objective disease progression or death regardless of whether the participants withdrew from randomized therapy or received another anticancer therapy prior to progression (i.e., date of PFS event or censoring - date of randomization +1).
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Timepoint [6]
0
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Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)
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Secondary outcome [7]
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Objective Response Rate (ORR) as Per RECIST 1.1 Using Investigator Assessment
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Assessment method [7]
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ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with an unconfirmed response of complete response (CR) or partial response (PR). CR was defined as disappearance of all target lesions (TLs). Any pathological lymph nodes selected as TLs had a reduction in short axis to \< 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference the baseline sum of diameters if criteria for PD are not met.
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Timepoint [7]
0
0
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)
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Secondary outcome [8]
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ORR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >= 25% LREM Analysis Set
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Assessment method [8]
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ORR (per RECIST 1.1 using Investigator assessments)was defined as the percentage of participants with an unconfirmed response of CR or PR. CR was defined as disappearance of all TLs. Any pathological lymph nodes selected as TLs had a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference the baseline sum of diameters if criteria for PD are not met.
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Timepoint [8]
0
0
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)
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Secondary outcome [9]
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ORR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >= 50% Analysis Set
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Assessment method [9]
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ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with an unconfirmed response of CR or PR. CR was defined as disappearance of all TLs. Any pathological lymph nodes selected as TLs had a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference the baseline sum of diameters if criteria for PD are not met.
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Timepoint [9]
0
0
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)
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Secondary outcome [10]
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0
ORR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >= 50% LREM Analysis Set
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Assessment method [10]
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0
ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with an unconfirmed response of CR or PR. CR was defined as disappearance of all TLs. Any pathological lymph nodes selected as TLs had a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference the baseline sum of diameters if criteria for PD are not met.
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Timepoint [10]
0
0
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)
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Secondary outcome [11]
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Duration of Response (DoR) as Per RECIST 1.1 Using Investigator Assessment
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Assessment method [11]
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DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). DoR was calculated using the Kaplan-Meier technique.
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Timepoint [11]
0
0
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)
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Secondary outcome [12]
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0
DoR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >=25% LREM Analysis Set
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Assessment method [12]
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0
DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). DoR was calculated using the Kaplan-Meier technique.
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Timepoint [12]
0
0
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)
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Secondary outcome [13]
0
0
DoR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >=50% Analysis Set
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Assessment method [13]
0
0
DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). DoR was calculated using the Kaplan-Meier technique.
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Timepoint [13]
0
0
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)
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Secondary outcome [14]
0
0
DoR as Per RECIST 1.1 Using Investigator Assessment in PD-L1 TC >=50% LREM Analysis Set
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Assessment method [14]
0
0
DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). DoR was calculated using the Kaplan-Meier technique.
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Timepoint [14]
0
0
Tumor assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of randomization and then every 8 weeks thereafter until confirmed objective disease progression (up to a maximum of approximately 69 months)
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Secondary outcome [15]
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Alive and Progression-Free at 12 Months (APF12)
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Assessment method [15]
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The APF12 was defined as the Kaplan-Meier estimate of percentage of participants alive and progression free at 12 months based on PFS (per RECIST 1.1 as assessed using Investigator assessments) analysis.
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Timepoint [15]
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From date of randomization until 12 months
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Secondary outcome [16]
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0
APF12 in PD-L1 TC >= 25% LREM Analysis Set
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Assessment method [16]
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0
The APF12 was defined as the Kaplan-Meier estimate of percentage of participants alive and progression free at 12 months based on PFS (per RECIST 1.1 as assessed using Investigator assessments) analysis.
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Timepoint [16]
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0
From date of randomization until 12 months
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Secondary outcome [17]
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0
APF12 in PD-L1 TC >= 50% Analysis Set
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Assessment method [17]
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0
The APF12 was defined as the Kaplan-Meier estimate of percentage of participants alive and progression free at 12 months based on PFS (per RECIST 1.1 as assessed using Investigator assessments) analysis.
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Timepoint [17]
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0
From date of randomization until 12 months
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Secondary outcome [18]
0
0
APF12 in PD-L1 TC >= 50% LREM Analysis Set
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Assessment method [18]
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0
The APF12 was defined as the Kaplan-Meier estimate of percentage of participants alive and progression free at 12 months based on PFS (per RECIST 1.1 as assessed using Investigator assessments) analysis.
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Timepoint [18]
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From date of randomization until 12 months
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Secondary outcome [19]
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Time From Randomization to Second Progression (PFS2)
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Assessment method [19]
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PFS2 was defined as the time from the date of randomization to the earliest of the progression events defined according to local clinical practice (subsequent to that used for the primary variable PFS) or death (i.e., date of PFS2 event or censoring - date of randomization + 1). PFS2 was calculated using the Kaplan-Meier technique.
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Timepoint [19]
0
0
Tumor assessments (per RECIST 1.1) until confirmed objective disease progression. Disease then assessed as per local practice until 2nd progression or death (up to a maximum of approximately 69 months)
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Secondary outcome [20]
0
0
PFS2 in PD-L1 TC >= 25% LREM Analysis Set
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Assessment method [20]
0
0
PFS2 was defined as the time from the date of randomization to the earliest of the progression events defined according to local clinical practice (subsequent to that used for the primary variable PFS) or death (i.e., date of PFS2 event or censoring - date of randomization + 1). PFS2 was calculated using the Kaplan-Meier technique.
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Timepoint [20]
0
0
Tumor assessments (per RECIST 1.1) until confirmed objective disease progression. Disease then assessed as per local practice until 2nd progression or death (up to a maximum of approximately 69 months)
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Secondary outcome [21]
0
0
PFS2 in PD-L1 TC >= 50% Analysis Set
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Assessment method [21]
0
0
PFS2 was defined as the time from the date of randomization to the earliest of the progression events defined according to local clinical practice (subsequent to that used for the primary variable PFS) or death (i.e., date of PFS2 event or censoring - date of randomization + 1). PFS2 was calculated using the Kaplan-Meier technique.
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Timepoint [21]
0
0
Tumor assessments (per RECIST 1.1) until confirmed objective disease progression. Disease then assessed as per local practice until 2nd progression or death (up to a maximum of approximately 69 months)
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Secondary outcome [22]
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0
PFS2 in PD-L1 TC >= 50% LREM Analysis Set
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Assessment method [22]
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0
PFS2 was defined as the time from the date of randomization to the earliest of the progression events defined according to local clinical practice (subsequent to that used for the primary variable PFS) or death (i.e., date of PFS2 event or censoring - date of randomization + 1). PFS2 was calculated using the Kaplan-Meier technique.
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Timepoint [22]
0
0
Tumor assessments (per RECIST 1.1) until confirmed objective disease progression. Disease then assessed as per local practice until 2nd progression or death (up to a maximum of approximately 69 months)
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Secondary outcome [23]
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OS at 18 Months
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Assessment method [23]
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0
OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 18 months were defined as the Kaplan-Meier estimate of OS at 18 months.
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Timepoint [23]
0
0
From date of randomization till 18 months.
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Secondary outcome [24]
0
0
OS at 18 Months in PD-L1 TC > = 25% LREM Analysis Set
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Assessment method [24]
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0
OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 18 months were defined as the Kaplan-Meier estimate of OS at 18 months.
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Timepoint [24]
0
0
From date of randomization till 18 months
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Secondary outcome [25]
0
0
OS at 18 Months in PD-L1 TC >= 50% Analysis Set
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Assessment method [25]
0
0
OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 18 months were defined as the Kaplan-Meier estimate of OS at 18 months.
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Timepoint [25]
0
0
From date of randomization till 18 months
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Secondary outcome [26]
0
0
OS at 18 Months in PD-L1 TC >= 50% LREM Analysis Set
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Assessment method [26]
0
0
OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 18 months were defined as the Kaplan-Meier estimate of OS at 18 months.
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Timepoint [26]
0
0
From date of randomization till 18 months
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Secondary outcome [27]
0
0
OS at 24 Months
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Assessment method [27]
0
0
OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 24 months were defined as the Kaplan-Meier estimate of OS at 24 months.
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Timepoint [27]
0
0
From date of randomization till 24 months
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Secondary outcome [28]
0
0
OS at 24 Months in PD-L1 TC > = 25% LREM Analysis Set
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Assessment method [28]
0
0
OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 24 months were defined as the Kaplan-Meier estimate of OS at 24 months.
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Timepoint [28]
0
0
From date of randomization till 24 months
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Secondary outcome [29]
0
0
OS at 24 Months in PD-L1 TC >= 50% Analysis Set
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Assessment method [29]
0
0
OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 24 months were defined as the Kaplan-Meier estimate of OS at 24 months.
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Timepoint [29]
0
0
From date of randomization till 24 months
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Secondary outcome [30]
0
0
OS at 24 Months in PD-L1 TC >= 50% LREM Analysis Set
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Assessment method [30]
0
0
OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The percentage of participants alive at 24 months were defined as the Kaplan-Meier estimate of OS at 24 months.
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Timepoint [30]
0
0
From date of randomization till 24 months
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Secondary outcome [31]
0
0
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) 30-Item Core Quality of Life Questionnaire Version 3 (QLQ-C30)
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Assessment method [31]
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0
The EORTC QLQ-C30 consisted of 30 questions that were combined to produce 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), 5 individual items (dyspnea, insomnia, appetite loss, constipation, and diarrhea), and a global measure of health status. The EORTC QLQ-C30 was scored according to the EORTC QLQ-C30 scoring manual. An outcome variable consisted of a score from 0 to 100. Higher scores on the global health status and functioning scales indicate better health status/function, but higher scores on symptom scales/items represent greater symptom severity. Baseline was defined as the last non-missing assessment prior to randomization. The mixed model repeated measures (MMRM) analysis of EORTC QLQ-C30 considered all data from baseline to PD or 12 months.
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Timepoint [31]
0
0
Baseline and 12 months
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Secondary outcome [32]
0
0
Change From Baseline in EORTC QLQ-C30 in PD-L1 TC >= 25% LREM Analysis Set
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Assessment method [32]
0
0
The EORTC QLQ-C30 consisted of 30 questions that were combined to produce 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), 5 individual items (dyspnea, insomnia, appetite loss, constipation, and diarrhea), and a global measure of health status. The EORTC QLQ-C30 was scored according to the EORTC QLQ-C30 scoring manual. An outcome variable consisted of a score from 0 to 100. Higher scores on the global health status and functioning scales indicate better health status/function, but higher scores on symptom scales/items represent greater symptom severity. Baseline was defined as the last non-missing assessment prior to randomization. The MMRM analysis of EORTC QLQ-C30 considered all data from baseline to PD or 12 months.
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Timepoint [32]
0
0
Baseline and 12 months
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Secondary outcome [33]
0
0
Time to Deterioration of EORTC QLQ-C30
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Assessment method [33]
0
0
Time to symptom deterioration was defined as the time from the date of randomization until the date if the first clinically meaningful deterioration (a decrease in the function scales or the global health status/ health-related quality of life \[HRQoL\] from baseline of =10) that was confirmed at a subsequent visit or death in the absence of a clinically meaningful symptom deterioration, regardless of whether the participant withdraws from the study treatment or received another anticancer therapy prior to symptom deterioration. The EORTC QLQ-C30 consisted of 30 questions that were combined to produce 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), 5 individual items (dyspnea, insomnia, appetite loss, constipation, and diarrhea), and a global measure of health status. The EORTC QLQ-C30 was scored according to the EORTC QLQ-C30 scoring manual.
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Timepoint [33]
0
0
From randomization until date of first symptom deterioration that is confirmed, assessed up to a maximum of approximately 69 months (DCO 27 October 2022)
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Secondary outcome [34]
0
0
Time to Deterioration of EORTC QLQ-C30 in PD-L1 TC >= 25% LREM Analysis Set
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Assessment method [34]
0
0
Time to symptom deterioration was defined as the time from the date of randomization until the date if the first clinically meaningful deterioration a decrease in the function scales or the global health status/ HRQoL from baseline of =10) that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful symptom deterioration, regardless of whether the participant withdraws from the study treatment or received another anticancer therapy prior to symptom deterioration. The EORTC QLQ-C30 consisted of 30 questions that were combined to produce 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), 5 individual items (dyspnea, insomnia, appetite loss, constipation, and diarrhea), and a global measure of health status. The EORTC QLQ-C30 was scored according to the EORTC QLQ-C30 scoring manual.
Query!
Timepoint [34]
0
0
From randomization until date of first symptom deterioration that is confirmed, assessed up to a maximum of approximately 69 months (DCO 27 October 2022)
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Secondary outcome [35]
0
0
Change From Baseline in EORTC 13-Item Lung Cancer Quality of Life Questionnaire (QLQ-LC13)
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Assessment method [35]
0
0
The QLQ-LC13 is a lung cancer specific module from the EORTC for lung cancer that comprised of 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication. An outcome variable consisted of a score from 0 to 100. Higher scores on symptom scales represent greater symptom severity. Baseline was defined as the last non-missing assessment prior to randomization. The MMRM analysis of EORTC QLQ-LC13 considered all data from baseline to PD or 12 months.
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Timepoint [35]
0
0
Baseline and 12 months
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Secondary outcome [36]
0
0
Change From Baseline in EORTC QLQ-LC13 in PD-L1 TC >= 25% LREM Analysis Set
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Assessment method [36]
0
0
The QLQ-LC13 is a lung cancer specific module from the EORTC for lung cancer that comprised of 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication. An outcome variable consisted of a score from 0 to 100. Higher scores on symptom scales represent greater symptom severity. Baseline was defined as the last non-missing assessment prior to randomization. The MMRM analysis of EORTC QLQ-LC13 considered all data from baseline to PD or 12 months.
Query!
Timepoint [36]
0
0
Baseline and 12 months
Query!
Secondary outcome [37]
0
0
Time to Deterioration of EORTC QLQ-LC13
Query!
Assessment method [37]
0
0
Time to symptom deterioration was defined as the time from the date of randomization until the date if the first clinically meaningful symptom deterioration a decrease in the function scales or the global health status/ HRQoL from baseline of =10) that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful symptom deterioration, regardless of whether the participant withdraws from the study treatment or received another anticancer therapy prior to symptom deterioration. The QLQ-LC13 is a lung cancer specific module from the EORTC for lung cancer that comprised of 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication.
Query!
Timepoint [37]
0
0
From randomization until date of first symptom deterioration that is confirmed, assessed up to maximum of approximately 69 months (DCO 27 October 2022)
Query!
Secondary outcome [38]
0
0
Time to Deterioration of EORTC QLQ-LC13 in PD-L1 TC >= 25% LREM Analysis Set
Query!
Assessment method [38]
0
0
Time to symptom deterioration was defined as the time from the date of randomization until the date if the first clinically meaningful symptom deterioration a decrease in the function scales or the global health status/ HRQoL from baseline of =10) that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful symptom deterioration, regardless of whether the participant withdraws from the study treatment or received another anticancer therapy prior to symptom deterioration. The QLQ-LC13 is a lung cancer specific module from the EORTC for lung cancer that comprised of 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia), and pain medication.
Query!
Timepoint [38]
0
0
From randomization until date of first symptom deterioration that is confirmed, assessed up to maximum of approximately 69 months (DCO 27 October 2022)
Query!
Secondary outcome [39]
0
0
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Query!
Assessment method [39]
0
0
ECOG performance status was assessed at the times specified based on the following and scored as 0: fully active: able to carry out all usual activities without restrictions. 1: Restricted in strenuous activity, but ambulatory and able to carry out any work activities; up and about more than 50% of waking hours. 3: Capable of only limited self-care; confined to bed or chair more than 50% of waking hours. 4: Completely disabled; unable to carry out any self-care and totally confined to bed or chair and 5: death. Data for only participants with restricted activity has been reported.
Query!
Timepoint [39]
0
0
From Baseline and until follow-up period of 57 months
Query!
Secondary outcome [40]
0
0
Number of Participants With ECOG Performance Status in PD-L1 TC >=25% LREM Analysis Set
Query!
Assessment method [40]
0
0
ECOG performance status was assessed at the times specified based on the following and scored as 0: fully active: able to carry out all usual activities without restrictions. 1: Restricted in strenuous activity, but ambulatory and able to carry out any work activities; up and about more than 50% of waking hours. 3: Capable of only limited self-care; confined to bed or chair more than 50% of waking hours. 4: Completely disabled; unable to carry out any self-care and totally confined to bed or chair and 5: death. Data for only participants with restricted activity has been reported.
Query!
Timepoint [40]
0
0
From Baseline and until follow-up period of 57 months
Query!
Secondary outcome [41]
0
0
Percentage of Participants With Antidrug Antibody (ADA) Response to Durvalumab
Query!
Assessment method [41]
0
0
Treatment-emergent ADA positive was defined as either treatment-induced or treatment-boosted ADA. Treatment-boosted ADA was defined as a baseline positive ADA titer that was boosted to a 4-fold or higher-level following study drug administration. Persistently positive was defined as positive at least 2 post-baseline assessments with at least 16 weeks between the first and last positive assessment or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.
Query!
Timepoint [41]
0
0
Up to 24 weeks
Query!
Secondary outcome [42]
0
0
Percentage of Participants With ADA Response to Durvalumab in LREM Analysis Set
Query!
Assessment method [42]
0
0
Treatment-emergent ADA positive was defined as either treatment-induced or treatment-boosted ADA. Treatment-boosted ADA was defined as a baseline positive ADA titer that was boosted to a 4-fold or higher-level following study drug administration. Persistently positive was defined as positive at least 2 post-baseline assessments with at least 16 weeks between the first and last positive assessment or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.
Query!
Timepoint [42]
0
0
Up to 24 weeks
Query!
Eligibility
Key inclusion criteria
Inclusion Criteria
* Aged at least 18 years
* Documented evidence of Stage IV NSCLC
* No sensitizing EGFR mutation and ALK rearrangement
* PD-L1 high expression
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
130
Years
Query!
Query!
Sex
Both males and females
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Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Prior chemotherapy or any other systemic therapy for advanced NSCLC
* Prior exposure to immune-mediated therapy, including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines
* Brain metastases or spinal cord compression unless the patient is stable and off steroids for at least 14 days prior to start of study treatment
* Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant
* Active or prior documented autoimmune or inflammatory disorders (e.g., colitis or Crohn's disease]
Query!
Study design
Purpose of the study
Treatment
Query!
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?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
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Other design features
Query!
Phase
Phase 3
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Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
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Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
2/01/2017
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Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
3/06/2026
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Actual
Query!
Sample size
Target
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Accrual to date
Query!
Final
669
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Research Site - Box Hill
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Recruitment hospital [2]
0
0
Research Site - Gosford
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Recruitment hospital [3]
0
0
Research Site - Kogarah
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Recruitment hospital [4]
0
0
Research Site - St Leonards
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Recruitment postcode(s) [1]
0
0
3128 - Box Hill
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Recruitment postcode(s) [2]
0
0
2250 - Gosford
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Recruitment postcode(s) [3]
0
0
2217 - Kogarah
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Recruitment postcode(s) [4]
0
0
2065 - St Leonards
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Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
China
Query!
State/province [2]
0
0
Beijing
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Country [3]
0
0
China
Query!
State/province [3]
0
0
Bengbu
Query!
Country [4]
0
0
China
Query!
State/province [4]
0
0
Changchun
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Country [5]
0
0
China
Query!
State/province [5]
0
0
Changsha
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Country [6]
0
0
China
Query!
State/province [6]
0
0
Chengdu
Query!
Country [7]
0
0
China
Query!
State/province [7]
0
0
Chongqing
Query!
Country [8]
0
0
China
Query!
State/province [8]
0
0
Guangzhou
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Country [9]
0
0
China
Query!
State/province [9]
0
0
Haikou
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Country [10]
0
0
China
Query!
State/province [10]
0
0
Hangzhou
Query!
Country [11]
0
0
China
Query!
State/province [11]
0
0
Jinan
Query!
Country [12]
0
0
China
Query!
State/province [12]
0
0
Linhai
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Country [13]
0
0
China
Query!
State/province [13]
0
0
Nanchang
Query!
Country [14]
0
0
China
Query!
State/province [14]
0
0
Nanjing
Query!
Country [15]
0
0
China
Query!
State/province [15]
0
0
Ningbo
Query!
Country [16]
0
0
China
Query!
State/province [16]
0
0
Shanghai
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Country [17]
0
0
China
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State/province [17]
0
0
Shenyang
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Country [18]
0
0
China
Query!
State/province [18]
0
0
Shijiazhuang
Query!
Country [19]
0
0
China
Query!
State/province [19]
0
0
Urumqi
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Country [20]
0
0
China
Query!
State/province [20]
0
0
Wanzhou
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Country [21]
0
0
China
Query!
State/province [21]
0
0
Wenzhou
Query!
Country [22]
0
0
China
Query!
State/province [22]
0
0
Wuhan
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Country [23]
0
0
China
Query!
State/province [23]
0
0
Xi'an
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Country [24]
0
0
China
Query!
State/province [24]
0
0
Zhengzhou
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Country [25]
0
0
China
Query!
State/province [25]
0
0
Zhuhai
Query!
Country [26]
0
0
Hungary
Query!
State/province [26]
0
0
Budapest
Query!
Country [27]
0
0
Hungary
Query!
State/province [27]
0
0
Deszk
Query!
Country [28]
0
0
Hungary
Query!
State/province [28]
0
0
Farkasgyepü
Query!
Country [29]
0
0
Hungary
Query!
State/province [29]
0
0
Gyöngyös - Mátraháza
Query!
Country [30]
0
0
Hungary
Query!
State/province [30]
0
0
Székesfehérvár
Query!
Country [31]
0
0
Hungary
Query!
State/province [31]
0
0
Törökbálint
Query!
Country [32]
0
0
Korea, Republic of
Query!
State/province [32]
0
0
Changwon-si
Query!
Country [33]
0
0
Korea, Republic of
Query!
State/province [33]
0
0
Cheongju-si
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Country [34]
0
0
Korea, Republic of
Query!
State/province [34]
0
0
Daegu
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Country [35]
0
0
Korea, Republic of
Query!
State/province [35]
0
0
Incheon
Query!
Country [36]
0
0
Korea, Republic of
Query!
State/province [36]
0
0
Jinju-si
Query!
Country [37]
0
0
Korea, Republic of
Query!
State/province [37]
0
0
Seoul
Query!
Country [38]
0
0
Korea, Republic of
Query!
State/province [38]
0
0
Suwon-si
Query!
Country [39]
0
0
Netherlands
Query!
State/province [39]
0
0
Almelo
Query!
Country [40]
0
0
Poland
Query!
State/province [40]
0
0
Bialystok
Query!
Country [41]
0
0
Poland
Query!
State/province [41]
0
0
Grudziadz
Query!
Country [42]
0
0
Poland
Query!
State/province [42]
0
0
Koszalin
Query!
Country [43]
0
0
Poland
Query!
State/province [43]
0
0
Lublin
Query!
Country [44]
0
0
Poland
Query!
State/province [44]
0
0
Mrozy
Query!
Country [45]
0
0
Poland
Query!
State/province [45]
0
0
Warszawa
Query!
Country [46]
0
0
Poland
Query!
State/province [46]
0
0
Wroclaw
Query!
Country [47]
0
0
Russian Federation
Query!
State/province [47]
0
0
Arkhangelsk
Query!
Country [48]
0
0
Russian Federation
Query!
State/province [48]
0
0
Moscow
Query!
Country [49]
0
0
Russian Federation
Query!
State/province [49]
0
0
Novosibirsk
Query!
Country [50]
0
0
Russian Federation
Query!
State/province [50]
0
0
Omsk
Query!
Country [51]
0
0
Russian Federation
Query!
State/province [51]
0
0
Rostov-on-Don
Query!
Country [52]
0
0
Russian Federation
Query!
State/province [52]
0
0
Saint Petersburg
Query!
Country [53]
0
0
Russian Federation
Query!
State/province [53]
0
0
Saint-Petersburg
Query!
Country [54]
0
0
Russian Federation
Query!
State/province [54]
0
0
Sankt-Peterburg
Query!
Country [55]
0
0
Russian Federation
Query!
State/province [55]
0
0
St. Petersburg
Query!
Country [56]
0
0
Russian Federation
Query!
State/province [56]
0
0
Volgograd
Query!
Country [57]
0
0
Taiwan
Query!
State/province [57]
0
0
Taichung City
Query!
Country [58]
0
0
Taiwan
Query!
State/province [58]
0
0
Taichung
Query!
Country [59]
0
0
Taiwan
Query!
State/province [59]
0
0
Taipei
Query!
Country [60]
0
0
Thailand
Query!
State/province [60]
0
0
Bangkok
Query!
Country [61]
0
0
Thailand
Query!
State/province [61]
0
0
Muang
Query!
Country [62]
0
0
Thailand
Query!
State/province [62]
0
0
Songkla
Query!
Country [63]
0
0
Turkey
Query!
State/province [63]
0
0
Ankara
Query!
Country [64]
0
0
Turkey
Query!
State/province [64]
0
0
Istanbul
Query!
Country [65]
0
0
Turkey
Query!
State/province [65]
0
0
Malatya
Query!
Country [66]
0
0
Turkey
Query!
State/province [66]
0
0
Pamukkale
Query!
Country [67]
0
0
Vietnam
Query!
State/province [67]
0
0
Can Tho
Query!
Country [68]
0
0
Vietnam
Query!
State/province [68]
0
0
Hanoi
Query!
Country [69]
0
0
Vietnam
Query!
State/province [69]
0
0
Ho Chi Minh
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AstraZeneca
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a randomized, open-label, multi-center Phase III study to determine the efficacy and safety of durvalumab versus platinum-based SoC chemotherapy in the first-line treatment of advanced NSCLC in patients who are epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type and with PD-L1 high expression (PEARL)
Query!
Trial website
https://clinicaltrials.gov/study/NCT03003962
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
Query!
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Query!
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/62/NCT03003962/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/62/NCT03003962/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03003962