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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
2013-003331-30
Secondary ID [2] 0 0
GO28915
Universal Trial Number (UTN)
Trial acronym
OAK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Squamous Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Died: PP-ITT
Timepoint [1] 0 0
Baseline until death due to any cause (up to approximately 2.25 years)
Primary outcome [2] 0 0
Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP - 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.
Timepoint [2] 0 0
Baseline until death due to any cause (up to approximately 2.25 years)
Primary outcome [3] 0 0
Overall Survival (OS): PP-ITT - 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.
Timepoint [3] 0 0
Baseline until death due to any cause (up to approximately 2.25 years)
Primary outcome [4] 0 0
OS: TC1/2/3 or IC1/2/3 Subgroup of PP - 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.
Timepoint [4] 0 0
Baseline until death due to any cause (up to approximately 2.25 years)
Primary outcome [5] 0 0
OS: SP-ITT - 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.
Timepoint [5] 0 0
Baseline until death due to any cause (up to approximately 2.87 years)
Primary outcome [6] 0 0
OS: TC1/2/3 Or IC1/2/3 Subgroup of SP - 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.
Timepoint [6] 0 0
Baseline until death from any cause (approximately 2.87 years)
Primary outcome [7] 0 0
OS: TC2/3 or IC2/3 Subgroup of SP - 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.
Timepoint [7] 0 0
Baseline until death due to any cause (up to approximately 2.87 years)
Primary outcome [8] 0 0
OS: TC3 or IC3 Subgroup of SP - 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.
Timepoint [8] 0 0
Baseline until death due to any cause (up to approximately 2.87 years)
Secondary outcome [1] 0 0
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 - 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.
Timepoint [1] 0 0
Baseline up to PD or Death (up to approximately 2.25 years)
Secondary outcome [2] 0 0
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 - 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.
Timepoint [2] 0 0
Baseline up to PD or Death (up to approximately 2.25 years)
Secondary outcome [3] 0 0
Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT - 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.
Timepoint [3] 0 0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary outcome [4] 0 0
PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP - 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.
Timepoint [4] 0 0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary outcome [5] 0 0
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT - 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.
Timepoint [5] 0 0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary outcome [6] 0 0
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP - 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.
Timepoint [6] 0 0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary outcome [7] 0 0
Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT - 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.
Timepoint [7] 0 0
From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary outcome [8] 0 0
DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP - 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.
Timepoint [8] 0 0
From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary outcome [9] 0 0
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
Timepoint [9] 0 0
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])
Secondary outcome [10] 0 0
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Timepoint [10] 0 0
Predose (Hr 0), 30 minutes (min) post-infusion (infusion duration: 60 min) on Cycle 1 Day 1 (1 Cycle=21 days)
Secondary outcome [11] 0 0
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Timepoint [11] 0 0
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)
Secondary outcome [12] 0 0
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) - 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.
Timepoint [12] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)
Secondary outcome [13] 0 0
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items - 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).
Timepoint [13] 0 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)
Secondary outcome [14] 0 0
EORTC QLQ-C30 Questionnaire Score: Functional Subscales - 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).
Timepoint [14] 0 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)
Secondary outcome [15] 0 0
EORTC QLQ-C30 Questionnaire Score: GHS Scale - 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).
Timepoint [15] 0 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)
Secondary outcome [16] 0 0
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale - 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).
Timepoint [16] 0 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)
Secondary outcome [17] 0 0
EORTC QLQ-LC13 Questionnaire Score: Alopecia - 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.
Timepoint [17] 0 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)
Secondary outcome [18] 0 0
EORTC QLQ-LC13 Questionnaire Score: Coughing - 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.
Timepoint [18] 0 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)
Secondary outcome [19] 0 0
EORTC QLQ-LC13 Questionnaire Score: Dysphagia - 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.
Timepoint [19] 0 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)
Secondary outcome [20] 0 0
EORTC QLQ-LC13 Questionnaire Score: Dyspnea - 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.
Timepoint [20] 0 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)
Secondary outcome [21] 0 0
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis - 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.
Timepoint [21] 0 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)
Secondary outcome [22] 0 0
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder - 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.
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)
Secondary outcome [23] 0 0
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest - 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.
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)
Secondary outcome [24] 0 0
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy - 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.
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)
Secondary outcome [25] 0 0
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts - 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.
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)
Secondary outcome [26] 0 0
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth - 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.
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)
Secondary outcome [27] 0 0
PFS as Determined by Investigator Using RECIST v1.1: SP-ITT - 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.
Timepoint [27] 0 0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)
Secondary outcome [28] 0 0
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: SP-ITT - 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.
Timepoint [28] 0 0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)
Secondary outcome [29] 0 0
DOR as Determined by Investigator Using RECIST v1.1: SP ITT - 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.
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)

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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Colorado
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Florida
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Georgia
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Illinois
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United States of America
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Iowa
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Maine
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Michigan
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Minnesota
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Montana
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Nebraska
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Nevada
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New York
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Ohio
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Oklahoma
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Oregon
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Rhode Island
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Texas
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Virginia
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Washington
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Wisconsin
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Argentina
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Córdoba
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Argentina
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Provincia De Buenos Aires
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Argentina
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Rosario
Country [27] 0 0
Austria
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Innsbruck
Country [28] 0 0
Austria
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Salzburg
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Austria
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Vöcklabruck
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Brazil
State/province [30] 0 0
RS
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Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
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Canada
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Quebec
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Chile
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Recoleta
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Chile
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Temuco
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Chile
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Vina Del Mar
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Finland
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Helsinki
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Finland
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Oulu
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Finland
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Tampere
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France
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Avignon
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France
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Besancon
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France
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Bordeaux
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France
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Caen
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France
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Creteil
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France
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Grenoble
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France
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Le Mans
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France
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Lille
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France
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Marseille
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France
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Mulhouse
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France
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Paris
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France
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Pierre Benite
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France
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Pringy
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France
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Rennes
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France
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Strasbourg
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France
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Suresnes
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France
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Toulon
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France
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Toulouse
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Gauting
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Germany
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Halle
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Germany
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Heidelberg
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Germany
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Hemer
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Germany
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Immenhausen
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Germany
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Köln
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Germany
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Regensburg
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Greece
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Athens
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Greece
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Patras
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Greece
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Thermi Thessalonikis
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Guatemala
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Guatemala City
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Hungary
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Budapest
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Hungary
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Pecs
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Hungary
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Torokbalint
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Campania
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Italy
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Emilia-Romagna
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Italy
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Friuli-Venezia Giulia
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Puglia
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Italy
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Sicilia
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Italy
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Toscana
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Italy
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Veneto
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Hyogo
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Japan
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Miyagi
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Shizuoka
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Japan
State/province [94] 0 0
Tokyo
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Japan
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Yamaguchi
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Netherlands
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'S Hertogenbosch
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Netherlands
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Eindhoven
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Netherlands
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Nieuwegein
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New Zealand
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Auckland
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New Zealand
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Dunedin
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New Zealand
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Hamilton
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Norway
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Oslo
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Panama
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Panama
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Poland
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Gdansk
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Poland
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Lodz
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Otwock
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Poland
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Poznan
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Poland
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Warszawa
Country [111] 0 0
Portugal
State/province [111] 0 0
Coimbra
Country [112] 0 0
Portugal
State/province [112] 0 0
Lisboa
Country [113] 0 0
Portugal
State/province [113] 0 0
Porto
Country [114] 0 0
Russian Federation
State/province [114] 0 0
Moscow
Country [115] 0 0
Russian Federation
State/province [115] 0 0
Saint-Petersburg
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Samara
Country [117] 0 0
Serbia
State/province [117] 0 0
Belgrade
Country [118] 0 0
Serbia
State/province [118] 0 0
Sremska Kamenica
Country [119] 0 0
Spain
State/province [119] 0 0
LAS Palmas
Country [120] 0 0
Spain
State/province [120] 0 0
Madrid
Country [121] 0 0
Spain
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La Coruña
Country [122] 0 0
Spain
State/province [122] 0 0
Malaga
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Spain
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Zaragoza
Country [124] 0 0
Sweden
State/province [124] 0 0
Goeteborg
Country [125] 0 0
Sweden
State/province [125] 0 0
Linköping
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Sweden
State/province [126] 0 0
Stockholm
Country [127] 0 0
Switzerland
State/province [127] 0 0
Baden
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Switzerland
State/province [128] 0 0
Geneve
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Switzerland
State/province [129] 0 0
Luzern
Country [130] 0 0
Taiwan
State/province [130] 0 0
Taichung
Country [131] 0 0
Taiwan
State/province [131] 0 0
Taipei
Country [132] 0 0
Taiwan
State/province [132] 0 0
Taoyuan
Country [133] 0 0
Thailand
State/province [133] 0 0
Bangkok
Country [134] 0 0
Turkey
State/province [134] 0 0
Istanbul
Country [135] 0 0
Turkey
State/province [135] 0 0
Izmir
Country [136] 0 0
Ukraine
State/province [136] 0 0
Dnipropetrovsk
Country [137] 0 0
Ukraine
State/province [137] 0 0
Kharkiv
Country [138] 0 0
Ukraine
State/province [138] 0 0
Uzhgorod
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Grimsby
Country [140] 0 0
United Kingdom
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London
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Manchester
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Sutton in Ashfield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02008227
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications