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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02008227
Registration number
NCT02008227
Ethics application status
Date submitted
6/12/2013
Date registered
11/12/2013
Date last updated
20/12/2019
Titles & IDs
Public title
A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy
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Scientific title
A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy
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Secondary ID [1]
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2013-003331-30
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Secondary ID [2]
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GO28915
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Universal Trial Number (UTN)
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Trial acronym
OAK
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Squamous Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Docetaxel
Experimental: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody - Atezolizumab 1200 milligrams (mg) was administered via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.
Active Comparator: Docetaxel - Docetaxel 75 milligrams per meter square (mg/m^2) was administered via IV infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.
Treatment: Drugs: Atezolizumab
1200 mg IV infusion on Day 1 of each 21-day cycle
Treatment: Drugs: Docetaxel
75 mg/m^2 IV infusion on Day 1 of each 21-day cycle
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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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Percentage of Participants Who Died: PP-ITT
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Assessment method [1]
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Timepoint [1]
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Baseline until death due to any cause (up to approximately 2.25 years)
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Primary outcome [2]
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Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP
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Assessment method [2]
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Percentage of participants who died among TC1/2/3 or IC1/2/3 subgroup of PP-ITT were reported. TC1 = presence of discernible programmed death-ligand 1 (PD-L1) staining of any intensity in >/=1% and <5% TCs; TC2: presence of discernible PD-L1 staining of any intensity in >/=5% and <50% TCs; TC3 = presence of discernible PD-L1 staining of any intensity in >/=50% TCs; IC1 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=1% and <5% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC2 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=5% and <10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC3 = presence of discernible PD-L1 staining of any intensity in ICs covering >/=10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma.
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Timepoint [2]
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Baseline until death due to any cause (up to approximately 2.25 years)
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Primary outcome [3]
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Overall Survival (OS): PP-ITT
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Assessment method [3]
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OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
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Timepoint [3]
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Baseline until death due to any cause (up to approximately 2.25 years)
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Primary outcome [4]
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OS: TC1/2/3 or IC1/2/3 Subgroup of PP
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Assessment method [4]
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OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
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Timepoint [4]
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Baseline until death due to any cause (up to approximately 2.25 years)
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Primary outcome [5]
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OS: SP-ITT
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Assessment method [5]
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OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
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Timepoint [5]
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Baseline until death due to any cause (up to approximately 2.87 years)
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Primary outcome [6]
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OS: TC1/2/3 Or IC1/2/3 Subgroup of SP
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Assessment method [6]
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OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
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Timepoint [6]
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Baseline until death from any cause (approximately 2.87 years)
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Primary outcome [7]
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OS: TC2/3 or IC2/3 Subgroup of SP
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Assessment method [7]
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OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
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Timepoint [7]
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Baseline until death due to any cause (up to approximately 2.87 years)
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Primary outcome [8]
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OS: TC3 or IC3 Subgroup of SP
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Assessment method [8]
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OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
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Timepoint [8]
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Baseline until death due to any cause (up to approximately 2.87 years)
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Secondary outcome [1]
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Percentage of Participants With Disease Progression (PD) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death: PP-ITT
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Assessment method [1]
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PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeters (mm), or presence of new lesions.
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Timepoint [1]
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Baseline up to PD or Death (up to approximately 2.25 years)
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Secondary outcome [2]
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Percentage of Participants With PD as Determined by Investigator Using RECIST v1.1 or Death: TC1/2/3 or IC1/2/3 Subgroup of PP
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Assessment method [2]
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PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
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Timepoint [2]
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Baseline up to PD or Death (up to approximately 2.25 years)
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Secondary outcome [3]
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Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT
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Assessment method [3]
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PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
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Timepoint [3]
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Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
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Secondary outcome [4]
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PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
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Assessment method [4]
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PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
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Timepoint [4]
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Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
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Secondary outcome [5]
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Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT
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Assessment method [5]
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Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.
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Timepoint [5]
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Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
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Secondary outcome [6]
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Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
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Assessment method [6]
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Objective response is defined as a CR or PR as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.
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Timepoint [6]
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Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
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Secondary outcome [7]
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Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT
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Assessment method [7]
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DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.
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Timepoint [7]
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From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
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Secondary outcome [8]
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DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
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Assessment method [8]
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DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.
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Timepoint [8]
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From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
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Secondary outcome [9]
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Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
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Assessment method [9]
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Timepoint [9]
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Baseline up to approximately 2.25 years (assessed at predose [Hour {Hr} 0] on Day 1 of Cycles 1, 2, 3, 4, 8, 16, then every 8 cycles up to end of treatment (EOT) [approximately 2.25 years]; 120 days after EOT [approximately 2.25 years] [1 Cycle=21 days])
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Secondary outcome [10]
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Maximum Observed Serum Atezolizumab Concentration (Cmax)
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Assessment method [10]
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0
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Timepoint [10]
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Predose (Hr 0), 30 minutes (min) post-infusion (infusion duration: 60 min) on Cycle 1 Day 1 (1 Cycle=21 days)
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Secondary outcome [11]
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Minimum Observed Serum Atezolizumab Concentration (Cmin)
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Assessment method [11]
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Timepoint [11]
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Predose (Hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24, 32, EOT (approximately 2.25 years); 120 days after EOT (approximately 2.25 years) (1 Cycle=21 days)
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Secondary outcome [12]
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Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)
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Assessment method [12]
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TTD in patient-reported lung cancer symptoms (pain in chest or in arm/shoulder, dyspnea, or cough) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the symptoms. A >/=10-point change in the score perceived by participants was considered as clinically significant. The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity.
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Timepoint [12]
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Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)
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Secondary outcome [13]
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EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
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Assessment method [13]
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EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
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Timepoint [13]
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Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
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Secondary outcome [14]
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EORTC QLQ-C30 Questionnaire Score: Functional Subscales
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Assessment method [14]
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EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
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Timepoint [14]
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Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
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Secondary outcome [15]
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EORTC QLQ-C30 Questionnaire Score: GHS Scale
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Assessment method [15]
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EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
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Timepoint [15]
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Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
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Secondary outcome [16]
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EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
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Assessment method [16]
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EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
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Timepoint [16]
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Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
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Secondary outcome [17]
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EORTC QLQ-LC13 Questionnaire Score: Alopecia
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Assessment method [17]
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QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for alopecia.
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Timepoint [17]
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Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
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Secondary outcome [18]
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EORTC QLQ-LC13 Questionnaire Score: Coughing
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Assessment method [18]
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0
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for coughing.
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Timepoint [18]
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Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
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Secondary outcome [19]
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EORTC QLQ-LC13 Questionnaire Score: Dysphagia
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Assessment method [19]
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0
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dysphagia.
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Timepoint [19]
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0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
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Secondary outcome [20]
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EORTC QLQ-LC13 Questionnaire Score: Dyspnea
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Assessment method [20]
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0
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dyspnea.
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Timepoint [20]
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0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
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Secondary outcome [21]
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EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
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Assessment method [21]
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0
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for hemoptysis.
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Timepoint [21]
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0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
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Secondary outcome [22]
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0
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
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Assessment method [22]
0
0
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in arm or shoulder.
Query!
Timepoint [22]
0
0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
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Secondary outcome [23]
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0
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
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Assessment method [23]
0
0
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in chest.
Query!
Timepoint [23]
0
0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Query!
Secondary outcome [24]
0
0
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Query!
Assessment method [24]
0
0
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for peripheral neuropathy.
Query!
Timepoint [24]
0
0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Query!
Secondary outcome [25]
0
0
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Query!
Assessment method [25]
0
0
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in other parts.
Query!
Timepoint [25]
0
0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Query!
Secondary outcome [26]
0
0
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Query!
Assessment method [26]
0
0
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for sore mouth.
Query!
Timepoint [26]
0
0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Query!
Secondary outcome [27]
0
0
PFS as Determined by Investigator Using RECIST v1.1: SP-ITT
Query!
Assessment method [27]
0
0
PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
Query!
Timepoint [27]
0
0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)
Query!
Secondary outcome [28]
0
0
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: SP-ITT
Query!
Assessment method [28]
0
0
Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.
Query!
Timepoint [28]
0
0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)
Query!
Secondary outcome [29]
0
0
DOR as Determined by Investigator Using RECIST v1.1: SP ITT
Query!
Assessment method [29]
0
0
DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.
Query!
Timepoint [29]
0
0
From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)
Query!
Eligibility
Key inclusion criteria
- Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC
- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
- Disease progression during or following treatment with a prior platinum-containing
regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease
recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant
regimen or combined modality (e.g., chemoradiation) regimen with curative intent
- Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors
(RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Known active or untreated central nervous system (CNS) metastases
- Malignancies other than NSCLC within 5 years prior to randomization, with the
exception of those with a negligible risk of metastasis or death and treated with
expected curative outcome
- History of autoimmune disease
- History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced
pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening
chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation
field (fibrosis) is permitted
- Active hepatitis B or hepatitis C
- Prior treatment with docetaxel
- Prior treatment with cluster of differentiation 137 (CD137) agonists,
anti-cytotoxic-T-lymphocyte-associated antigen 4 (anti-CTLA4), anti-programmed death-1
(anti-PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
11/03/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
9/01/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1225
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Illinois
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Iowa
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Maine
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Michigan
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Minnesota
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Montana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Nebraska
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Nevada
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New Jersey
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Mexico
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New York
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Ohio
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Oklahoma
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Oregon
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Rhode Island
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Texas
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Virginia
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Washington
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Wisconsin
Query!
Country [24]
0
0
Argentina
Query!
State/province [24]
0
0
Córdoba
Query!
Country [25]
0
0
Argentina
Query!
State/province [25]
0
0
Provincia De Buenos Aires
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
Rosario
Query!
Country [27]
0
0
Austria
Query!
State/province [27]
0
0
Innsbruck
Query!
Country [28]
0
0
Austria
Query!
State/province [28]
0
0
Salzburg
Query!
Country [29]
0
0
Austria
Query!
State/province [29]
0
0
Vöcklabruck
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
RS
Query!
Country [31]
0
0
Canada
Query!
State/province [31]
0
0
Alberta
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
Ontario
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
Quebec
Query!
Country [34]
0
0
Chile
Query!
State/province [34]
0
0
Recoleta
Query!
Country [35]
0
0
Chile
Query!
State/province [35]
0
0
Temuco
Query!
Country [36]
0
0
Chile
Query!
State/province [36]
0
0
Vina Del Mar
Query!
Country [37]
0
0
Finland
Query!
State/province [37]
0
0
Helsinki
Query!
Country [38]
0
0
Finland
Query!
State/province [38]
0
0
Oulu
Query!
Country [39]
0
0
Finland
Query!
State/province [39]
0
0
Tampere
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Avignon
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Besancon
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Bordeaux
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Caen
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Creteil
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Grenoble
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Le Mans
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Lille
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Marseille
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Mulhouse
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Paris
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Pierre Benite
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Pringy
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Rennes
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Strasbourg
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Suresnes
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Toulon
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Toulouse
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Berlin
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Frankfurt
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Gauting
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Halle
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Heidelberg
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Hemer
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Immenhausen
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Köln
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Regensburg
Query!
Country [67]
0
0
Greece
Query!
State/province [67]
0
0
Athens
Query!
Country [68]
0
0
Greece
Query!
State/province [68]
0
0
Patras
Query!
Country [69]
0
0
Greece
Query!
State/province [69]
0
0
Thermi Thessalonikis
Query!
Country [70]
0
0
Guatemala
Query!
State/province [70]
0
0
Guatemala City
Query!
Country [71]
0
0
Hungary
Query!
State/province [71]
0
0
Budapest
Query!
Country [72]
0
0
Hungary
Query!
State/province [72]
0
0
Pecs
Query!
Country [73]
0
0
Hungary
Query!
State/province [73]
0
0
Torokbalint
Query!
Country [74]
0
0
Italy
Query!
State/province [74]
0
0
Campania
Query!
Country [75]
0
0
Italy
Query!
State/province [75]
0
0
Emilia-Romagna
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
Friuli-Venezia Giulia
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Lazio
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Liguria
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Lombardia
Query!
Country [80]
0
0
Italy
Query!
State/province [80]
0
0
Puglia
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Sicilia
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
Toscana
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
Veneto
Query!
Country [84]
0
0
Japan
Query!
State/province [84]
0
0
Aichi
Query!
Country [85]
0
0
Japan
Query!
State/province [85]
0
0
Chiba
Query!
Country [86]
0
0
Japan
Query!
State/province [86]
0
0
Ehime
Query!
Country [87]
0
0
Japan
Query!
State/province [87]
0
0
Fukuoka
Query!
Country [88]
0
0
Japan
Query!
State/province [88]
0
0
Hyogo
Query!
Country [89]
0
0
Japan
Query!
State/province [89]
0
0
Miyagi
Query!
Country [90]
0
0
Japan
Query!
State/province [90]
0
0
Okayama
Query!
Country [91]
0
0
Japan
Query!
State/province [91]
0
0
Osaka
Query!
Country [92]
0
0
Japan
Query!
State/province [92]
0
0
Saitama
Query!
Country [93]
0
0
Japan
Query!
State/province [93]
0
0
Shizuoka
Query!
Country [94]
0
0
Japan
Query!
State/province [94]
0
0
Tokyo
Query!
Country [95]
0
0
Japan
Query!
State/province [95]
0
0
Yamaguchi
Query!
Country [96]
0
0
Korea, Republic of
Query!
State/province [96]
0
0
Gyeonggi-do
Query!
Country [97]
0
0
Korea, Republic of
Query!
State/province [97]
0
0
Seoul
Query!
Country [98]
0
0
Netherlands
Query!
State/province [98]
0
0
'S Hertogenbosch
Query!
Country [99]
0
0
Netherlands
Query!
State/province [99]
0
0
Eindhoven
Query!
Country [100]
0
0
Netherlands
Query!
State/province [100]
0
0
Nieuwegein
Query!
Country [101]
0
0
New Zealand
Query!
State/province [101]
0
0
Auckland
Query!
Country [102]
0
0
New Zealand
Query!
State/province [102]
0
0
Dunedin
Query!
Country [103]
0
0
New Zealand
Query!
State/province [103]
0
0
Hamilton
Query!
Country [104]
0
0
Norway
Query!
State/province [104]
0
0
Oslo
Query!
Country [105]
0
0
Panama
Query!
State/province [105]
0
0
Panama
Query!
Country [106]
0
0
Poland
Query!
State/province [106]
0
0
Gdansk
Query!
Country [107]
0
0
Poland
Query!
State/province [107]
0
0
Lodz
Query!
Country [108]
0
0
Poland
Query!
State/province [108]
0
0
Otwock
Query!
Country [109]
0
0
Poland
Query!
State/province [109]
0
0
Poznan
Query!
Country [110]
0
0
Poland
Query!
State/province [110]
0
0
Warszawa
Query!
Country [111]
0
0
Portugal
Query!
State/province [111]
0
0
Coimbra
Query!
Country [112]
0
0
Portugal
Query!
State/province [112]
0
0
Lisboa
Query!
Country [113]
0
0
Portugal
Query!
State/province [113]
0
0
Porto
Query!
Country [114]
0
0
Russian Federation
Query!
State/province [114]
0
0
Moscow
Query!
Country [115]
0
0
Russian Federation
Query!
State/province [115]
0
0
Saint-Petersburg
Query!
Country [116]
0
0
Russian Federation
Query!
State/province [116]
0
0
Samara
Query!
Country [117]
0
0
Serbia
Query!
State/province [117]
0
0
Belgrade
Query!
Country [118]
0
0
Serbia
Query!
State/province [118]
0
0
Sremska Kamenica
Query!
Country [119]
0
0
Spain
Query!
State/province [119]
0
0
LAS Palmas
Query!
Country [120]
0
0
Spain
Query!
State/province [120]
0
0
Madrid
Query!
Country [121]
0
0
Spain
Query!
State/province [121]
0
0
La Coruña
Query!
Country [122]
0
0
Spain
Query!
State/province [122]
0
0
Malaga
Query!
Country [123]
0
0
Spain
Query!
State/province [123]
0
0
Zaragoza
Query!
Country [124]
0
0
Sweden
Query!
State/province [124]
0
0
Goeteborg
Query!
Country [125]
0
0
Sweden
Query!
State/province [125]
0
0
Linköping
Query!
Country [126]
0
0
Sweden
Query!
State/province [126]
0
0
Stockholm
Query!
Country [127]
0
0
Switzerland
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State/province [127]
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Baden
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Country [128]
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Switzerland
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State/province [128]
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Geneve
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Country [129]
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Switzerland
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State/province [129]
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Luzern
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Taiwan
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Taichung
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Taiwan
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State/province [131]
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Taipei
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Country [132]
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Taiwan
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State/province [132]
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Taoyuan
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Country [133]
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Thailand
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State/province [133]
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Bangkok
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Turkey
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Istanbul
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Country [135]
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Turkey
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State/province [135]
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Izmir
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Country [136]
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Ukraine
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State/province [136]
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Dnipropetrovsk
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Country [137]
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Ukraine
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State/province [137]
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Kharkiv
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Country [138]
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Ukraine
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State/province [138]
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Uzhgorod
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Country [139]
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United Kingdom
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State/province [139]
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Grimsby
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Country [140]
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United Kingdom
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State/province [140]
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London
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Country [141]
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United Kingdom
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State/province [141]
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Manchester
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Country [142]
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United Kingdom
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State/province [142]
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Sutton in Ashfield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
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Summary
Brief summary
This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and
safety of atezolizumab (an anti-programmed death-ligand 1 [anti-PD-L1] antibody)compared with
docetaxel in participants with locally advanced or metastatic non-small cell lung cancer
(NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1
to receive either docetaxel or atezolizumab. Treatment may continue as long as participants
experienced clinical benefit as assessed by the investigator, i.e., in the absence of
unacceptable toxicity or symptomatic deterioration attributed to disease progression.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02008227
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Address
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Hoffmann-La Roche
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02008227
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