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 (OAK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02008227

Recruitment Status : Completed

First Posted : December 11, 2013

Results First Posted : July 2, 2017

Last Update Posted : December 20, 2019

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non-Squamous Non-Small Cell Lung Cancer	Drug: Atezolizumab Drug: Docetaxel	Phase 3

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1225 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official 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
Actual Study Start Date :	March 11, 2014
Actual Primary Completion Date :	July 7, 2016
Actual Study Completion Date :	January 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Docetaxel Atezolizumab

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle Other Name: Tecentriq
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.	Drug: Docetaxel 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle

Outcome Measures

Primary Outcome Measures :

Percentage of Participants Who Died: PP-ITT [ Time Frame: Baseline until death due to any cause (up to approximately 2.25 years) ]
Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP [ Time Frame: Baseline until death due to any cause (up to approximately 2.25 years) ]
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.
Overall Survival (OS): PP-ITT [ Time Frame: Baseline until death due to any cause (up to approximately 2.25 years) ]
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.
OS: TC1/2/3 or IC1/2/3 Subgroup of PP [ Time Frame: Baseline until death due to any cause (up to approximately 2.25 years) ]
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.
OS: SP-ITT [ Time Frame: Baseline until death due to any cause (up to approximately 2.87 years) ]
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.
OS: TC1/2/3 Or IC1/2/3 Subgroup of SP [ Time Frame: Baseline until death from any cause (approximately 2.87 years) ]
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.
OS: TC2/3 or IC2/3 Subgroup of SP [ Time Frame: Baseline until death due to any cause (up to approximately 2.87 years) ]
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.
OS: TC3 or IC3 Subgroup of SP [ Time Frame: Baseline until death due to any cause (up to approximately 2.87 years) ]
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.

Secondary Outcome Measures :

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 [ Time Frame: Baseline up to PD or Death (up to approximately 2.25 years) ]
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.
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 [ Time Frame: Baseline up to PD or Death (up to approximately 2.25 years) ]
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.
Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT [ Time Frame: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years) ]
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.
PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP [ Time Frame: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years) ]
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.
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT [ Time Frame: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years) ]
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.
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP [ Time Frame: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years) ]
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.
Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT [ Time Frame: 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) ]
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.
DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP [ Time Frame: 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) ]
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.
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab [ Time Frame: 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]) ]
Maximum Observed Serum Atezolizumab Concentration (Cmax) [ Time Frame: Predose (Hr 0), 30 minutes (min) post-infusion (infusion duration: 60 min) on Cycle 1 Day 1 (1 Cycle=21 days) ]
Minimum Observed Serum Atezolizumab Concentration (Cmin) [ Time Frame: 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) ]
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) [ Time Frame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days) ]
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.
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items [ Time Frame: 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) ]
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).
EORTC QLQ-C30 Questionnaire Score: Functional Subscales [ Time Frame: 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) ]
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).
EORTC QLQ-C30 Questionnaire Score: GHS Scale [ Time Frame: 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) ]
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).
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale [ Time Frame: 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) ]
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).
EORTC QLQ-LC13 Questionnaire Score: Alopecia [ Time Frame: 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) ]
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.
EORTC QLQ-LC13 Questionnaire Score: Coughing [ Time Frame: 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) ]
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.
EORTC QLQ-LC13 Questionnaire Score: Dysphagia [ Time Frame: 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) ]
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.
EORTC QLQ-LC13 Questionnaire Score: Dyspnea [ Time Frame: 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) ]
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.
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis [ Time Frame: 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) ]
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.
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder [ Time Frame: 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) ]
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.
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest [ Time Frame: 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) ]
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.
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy [ Time Frame: 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) ]
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.
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts [ Time Frame: 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) ]
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.
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth [ Time Frame: 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) ]
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.
PFS as Determined by Investigator Using RECIST v1.1: SP-ITT [ Time Frame: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years) ]
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.
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: SP-ITT [ Time Frame: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years) ]
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.
DOR as Determined by Investigator Using RECIST v1.1: SP ITT [ Time Frame: 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) ]
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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008227

Locations

Show 208 study locations

Layout table for location information

United States, California
Comprehensive Blood/Cancer Ctr
Bakersfield, California, United States, 93309
Roy & Patricia Disney Family Cancer Center
Burbank, California, United States, 91505
St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
Fullerton, California, United States, 92835
Kaiser Permanente - Hayward
Hayward, California, United States, 94545
Scripps Clinic; Hematology & Oncology
La Jolla, California, United States, 92037-1027
Pacific Shores Medical Group
Long Beach, California, United States, 90813
Univ of Calif, Los Angeles; Hematology/Oncology
Los Angeles, California, United States, 90095
North Valley Hem Onc Med Grp; Thomas&Dorothy Leavey Can Ctr
Northridge, California, United States, 91328
Kaiser Permanente - Oakland
Oakland, California, United States, 94611
TMPN/ Cancer Care Associates
Redondo Beach, California, United States, 90277
Kaiser Permanente - Roseville
Roseville, California, United States, 95661
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States, 95814
UC Davis; Comprehensive Cancer Center
Sacramento, California, United States, 95817
Kaiser Permanente - San Francisco (2238 Geary)
San Francisco, California, United States, 94115
K. Permanente - San Jose
San Jose, California, United States, 95119
Coastal Integrative Cancer Care
San Luis Obispo, California, United States, 93401
Kaiser Permanente - San Marcos
San Marcos, California, United States, 92069
K. Permanente - Santa Clara
Santa Clara, California, United States, 95051
Central Coast Medical Oncology
Santa Maria, California, United States, 93454
K. Permanente - S. San Fran
South San Francisco, California, United States, 94080
Kaiser Permanente - Vallejo
Vallejo, California, United States, 94589
K. Permanente - Walnut Creek
Walnut Creek, California, United States, 94596
United States, Colorado
St. Mary's Hospital Regional Cancer Center
Grand Junction, Colorado, United States, 81501
Kaiser Permanente - Franklin; Kaiser Permanente - Lone Tree
Lone Tree, Colorado, United States
United States, Florida
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
Jacksonville, Florida, United States, 32256
AMPM Research Clinic
Miami, Florida, United States, 33145
Orlando Health Inc.
Orlando, Florida, United States, 32806
United States, Georgia
Georgia Cancer Specialists
Atlanta, Georgia, United States, 30341
United States, Illinois
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Illinois Cancer Care
Peoria, Illinois, United States, 61615
Quincy Medical Group
Quincy, Illinois, United States, 62301
United States, Iowa
Hematology-Oncology; Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
United States, Maine
New England Cancer Specialists
Scarborough, Maine, United States, 04074
United States, Michigan
Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building
Detroit, Michigan, United States, 48201
United States, Minnesota
US Oncology Research at Minnesota Oncology
Minneapolis, Minnesota, United States, 55404
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Montana
Billings Clinic; Research Center
Billings, Montana, United States, 59101
Montana Cancer Specialists
Missoula, Montana, United States, 59802
United States, Nebraska
Oncology Hematology West Midwest
Omaha, Nebraska, United States, 68130
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89014
Comprehensive Cancer Centers of Nevada - Eastern Avenue
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Summit Medical Center
Florham Park, New Jersey, United States, 07932
Luckow Pavillion, Valley Hosp; Office of Clinical Trials
Paramus, New Jersey, United States, 07652
United States, New Mexico
San Juan Oncology Associates
Farmington, New Mexico, United States, 87401
United States, New York
Roswell Park Cancer Inst.
Buffalo, New York, United States, 14263
New York Oncology Hematology PC - Latham
Clifton Park, New York, United States, 12065
United States, Ohio
Mid Ohio Onc Hematology Inc
Columbus, Ohio, United States, 43219
United States, Oklahoma
Cancer Treatment Centers of America-Tulsa
Tulsa, Oklahoma, United States, 74133
United States, Oregon
Willamette Valley Cancer Ctr - 520 Country Club
Eugene, Oregon, United States, 97401-8122
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Texas
Texas Onc-Central Austin CA Ct
Austin, Texas, United States, 78731
The Methodist Cancer Center
Houston, Texas, United States, 77030
Texas Oncology, P.A. - Tyler; Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24014
United States, Washington
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, United States, 98684
United States, Wisconsin
Aurora Health Care; Patient Centered Research
Milwaukee, Wisconsin, United States, 53215
Argentina
Instituto Medico Rio Cuarto
Córdoba, Argentina
COIBA
Provincia De Buenos Aires, Argentina, B1884BBF
Instituto de Oncología de Rosario
Rosario, Argentina, S2000KZE
Austria
Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin
Innsbruck, Austria, 6020
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, Austria, 5020
Lkh Vöcklabruck; I. Abt. Für Innere Medizin
Vöcklabruck, Austria, 4840
Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, RS, Brazil, 90035-903
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Windsor Regional Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
Cite de La Sante de Laval; Hemato-Oncologie
Laval, Quebec, Canada, H7M 3L9
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, Canada, H3T 1E2
Chile
Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas
Recoleta, Chile, 8420383
Sociedad de Investigaciones Medicas Ltda (SIM)
Temuco, Chile, 4810469
ONCOCENTRO APYS; Oncología
Vina Del Mar, Chile, 2520598
Finland
Helsinki University Central Hospital; Dep. of Pulmonary Medicine
Helsinki, Finland, 00290
Oulu University Hospital; Oncology
Oulu, Finland, 90029
Tampere University Hospital; Dept of Oncology
Tampere, Finland, 33520
France
Institut Sainte Catherine
Avignon, France, 84918
Hopital Jean Minjoz; Pneumologie
Besancon, France, 25030
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
Bordeaux, France, 33077
Centre Francois Baclesse
Caen, France, 14076
Centre Hospitalier Intercommunal; Service de Pneumologie
Creteil, France, 94010
Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
Grenoble, France, 38043
Centre Jean Bernard; Radiotherapie Chimiotherapie
Le Mans, France, 72000
Centre Oscar Lambret
Lille, France, 59020
Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique
Marseille, France, 13915
Hopital Emile Muller;Pneumologie
Mulhouse, France, 68070
Hopital Cochin; Unite Fonctionnelle D Oncologie
Paris, France, 75014
Hopital Saint Louis; Oncologie Medicale
Paris, France, 75475
GH Paris Saint Joseph; Pneumologie
Paris, France, 75674
Hopital Tenon;Pneumologie
Paris, France, 75970
Centre Hospitalier Lyon Sud; Pneumologie
Pierre Benite, France, 69495
CH de la region d Annecy
Pringy, France, 74374
Hopital de Pontchaillou; Service de Pneumologie
Rennes, France, 35033
Centre Paul Strauss; Oncologie Medicale
Strasbourg, France, 67065
Hopital Foch; Pneumologie
Suresnes, France, 92151
Hia Sainte Anne; Pneumologie
Toulon, France, 83041
Hopital Larrey; Pneumologie
Toulouse, France, 31059
Germany
Helios Klinikum Emil von Behring GmbH
Berlin, Germany, 14165
Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
Frankfurt, Germany, 60488
Asklepios-Fachkliniken Muenchen-Gauting; Onkologie
Gauting, Germany, 82131
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
Halle, Germany, 06120
Thoraxklinik Heidelberg gGmbH
Heidelberg, Germany, 69126
Lungenklinik Hemer
Hemer, Germany, 58675
Fachklinik für Lungenerkrankungen
Immenhausen, Germany, 34376
Krankenhaus Merheim Lungenklinik
Köln, Germany, 51109
Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
Regensburg, Germany, 93053
Greece
Uoa Sotiria Hospital; Oncology
Athens, Greece, 115 27
University Hospital of Patras Medical Oncology
Patras, Greece, 265 04
Thermi Clinic; Oncology Clinic
Thermi Thessalonikis, Greece, 570 01
Guatemala
Grupo Angeles
Guatemala City, Guatemala, 01015
Hungary
Semmelweis Egyetem X; Pulmonologiai Klinika
Budapest, Hungary, 1083
University of Pecs, I st Dept of Internal Medicine
Pecs, Hungary, 7624
Tudogyogyintezet Torokbalint
Torokbalint, Hungary, 2045
Italy
Azienda Ospedaliera San Giuseppe Moscati
Avellino, Campania, Italy, 83100
Seconda Universita' Degli Studi; Divsione Di Oncologia Medica
Napoli, Campania, Italy, 80131
Azienda Ospedaliera Univ Parma; Dept Oncologia Medica
Parma, Emilia-Romagna, Italy, 43100
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
Aviano, Friuli-Venezia Giulia, Italy, 33081
Azienda Ospedaliero-Uni Ria Di Udine; Dept. Di Oncologia - Padiglione Pennato
Udine, Friuli-Venezia Giulia, Italy, 33100
Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna
Roma, Lazio, Italy, 00168
Istituto Nazionale per la Ricerca sul Cancro di Genova
Genova, Liguria, Italy, 16132
Irccs Ospedale San Raffaele;Oncologia Medica
Milano, Lombardia, Italy, 20132
Istituto Europeo Di Oncologia
Milano, Lombardia, Italy, 20141
ASST DI MONZA; Oncologia Medica
Monza, Lombardia, Italy, 20900
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari, Puglia, Italy, 70124
POLICLINICO RODOLICO, U.O. di Oncologia Medica
Catania, Sicilia, Italy, 95100
Ospedale San Luca; Oncologia
Lucca, Toscana, Italy, 55100
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
Pisa, Toscana, Italy, 56124
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
Padova, Veneto, Italy, 35128
A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina
Verona, Veneto, Italy, 37134
Japan
Aichi Cancer Center Hospital; Respiratory Medicine
Aichi, Japan, 464-8681
National Cancer Center Hospital East; Thoracic Oncology
Chiba, Japan, 277-8577
National Hospital Organization Shikoku Cancer Center; Internal Medicine
Ehime, Japan, 791-0280
National Hospital Organization Kyushu Cancer Center, Thoracic Oncology
Fukuoka, Japan, 811-1395
Kobe City Medical Center General Hospital; Respiratory Medicine
Hyogo, Japan, 650-0047
Hyogo Cancer Center; Thoracic Oncology
Hyogo, Japan, 673-8558
Miyagi Cancer Center; Respiratory Medicine
Miyagi, Japan, 981-1293
Okayama University Hospital; Respiratory and Allergy Medicine
Okayama, Japan, 700-8558
Kindai University Hospital; Medical Oncology
Osaka, Japan, 589-8511
National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine
Osaka, Japan, 591-8555
Saitama Cancer Center; Thoracic Oncology
Saitama, Japan, 362-0806
Shizuoka Cancer Center; Thoracic Oncology
Shizuoka, Japan, 411-8777
National Cancer Center Hospital; Thoracic Medical Oncology
Tokyo, Japan, 104-0045
The Cancer Institute Hospital of JFCR, Respiratory Medicine
Tokyo, Japan, 135-8550
Tokyo Medical University Hospital; Dept of Surgery
Tokyo, Japan, 160-0023
National Hospital Organization, Yamaguchi - Ube Medical Center; Oncology Medicine
Yamaguchi, Japan, 755-0241
Korea, Republic of
National Cancer Center; Medical Oncology
Gyeonggi-do, Korea, Republic of, 410-769
Seoul National University Bundang Hospital; Hematology Medical Oncology
Gyeonggi-do, Korea, Republic of, 463-707
Seoul National Uni Hospital; Internal Medicine
Seoul, Korea, Republic of, 03080
Yonsei University Severance Hospital; Medical Oncology
Seoul, Korea, Republic of, 120-752
Samsung Medical Center; Gastroenterology
Seoul, Korea, Republic of, 135-710
Seoul St.Mary's Hospital; Medical Oncology
Seoul, Korea, Republic of, 137-807
Netherlands
Jeroen Bosch Ziekenhuis
'S Hertogenbosch, Netherlands, 5223 GZ
Catharina Ziekenhuis; Dept of Lung Diseases
Eindhoven, Netherlands, 5623 EJ
Antonius Ziekenhuis; Dept of Lung Diseases
Nieuwegein, Netherlands, 3435 CM
New Zealand
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
Auckland, New Zealand, 1023
Dunedin Hospital
Dunedin, New Zealand
Waikato Hospital; Dept of Medical Oncology
Hamilton, New Zealand, 3240
Norway
Oslo Universitetssykehus HF; Radiumhospitalet
Oslo, Norway, 0310
Panama
Centro Hemato Oncologico Panama
Panama, Panama, 0832
Poland
Medical University of Gdansk
Gdansk, Poland, 80-952
Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
Lodz, Poland, 93-513
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
Otwock, Poland, 05-400
Med.-Polonia Sp. z o.o. NSZOZ
Poznan, Poland, 60-693
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
Warszawa, Poland, 02-781
Portugal
Hospital Geral; Servico de Pneumologia
Coimbra, Portugal, 3041-801
Hospital Pulido Valente; Servico de Pneumologia
Lisboa, Portugal, 1796-001
IPO do Porto; Servico de Oncologia Medica
Porto, Portugal, 4200-072
Russian Federation
N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
Moscow, Russian Federation, 105229
City Clinical Onc.
Saint-Petersburg, Russian Federation, 198255
SBI of Healthcare Samara Regional Clinical Oncology Dispensary
Samara, Russian Federation, 443031
Serbia
Clinic for Pulmonology, Clinical Center of Serbia
Belgrade, Serbia, 11000
Institute for pulmonary diseases of Vojvodina
Sremska Kamenica, Serbia, 21204
Spain
Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
Majadahonda, Madrid, Spain, 28222
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
La Coruña, Spain, 15006
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, Spain, 28034
Fundacion Jimenez Diaz; Servicio de Oncologia
Madrid, Spain, 28040
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, Spain, 28041
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, Spain, 28046
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Malaga, Spain, 29010
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, Spain, 50009
Sweden
Sahlgrenska Universitetssjukhuset, Lungmedicinkliniken
Goeteborg, Sweden, 41345
Universitetssjukhuset Linköping; Lungmedicinkliniken
Linköping, Sweden, 581 85
Karolinska Universitetssjukhuset, Solna; Lung Allergikliniken N10:02
Stockholm, Sweden, 171 76
Switzerland
Kantonsspital Baden; Medizinische Klinik, Onkologie
Baden, Switzerland, 5404
HUG; Oncologie
Geneve, Switzerland, 1211
Luzerner Kantonsspital; Medizinische Onkologie
Luzern, Switzerland, 6004
Taiwan
China Medical University Hospital
Taichung, Taiwan, 40447
National Taiwan Uni Hospital; Internal Medicine
Taipei, Taiwan, 100
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
Taipei, Taiwan, 112
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
Taoyuan, Taiwan, 333
Thailand
Chulalongkorn Hospital; Medical Oncology
Bangkok, Thailand, 10330
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Bangkok, Thailand, 10400
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, Thailand, 10700
Turkey
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul, Turkey, 34300
Izmir Suat Seren Chest Diseases and Surgery Research Hospital
Izmir, Turkey, 35110
Ukraine
State Medical Academy; Oncology
Dnipropetrovsk, Ukraine, 43102
Karkiv Regional Oncology Center
Kharkiv, Ukraine, 61070
Uzhgorod Nat. University Central Municip Hosp; Onc Center
Uzhgorod, Ukraine, 88000
United Kingdom
Diana Princess of Wales Hosp.
Grimsby, United Kingdom, DN33 2BA
University College London Hospital
London, United Kingdom, NW1 - 2PG
Royal Free Hospital
London, United Kingdom, NW3 2QS
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, United Kingdom, SE1 9RT
St George's Hospital
London, United Kingdom, SW17 0QT
Charing Cross Hospital
London, United Kingdom, W6 8RF
Christie Hospital NHS Trust
Manchester, United Kingdom, M20 4BX
Kings Mill Hospital
Sutton in Ashfield, United Kingdom, NG17 4JL

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Layout table for investigator information

Study Director:	Clinical Trials	Hoffmann-La Roche

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cortellini A, Ricciuti B, Borghaei H, Naqash AR, D'Alessio A, Fulgenzi CAM, Addeo A, Banna GL, Pinato DJ. Differential prognostic effect of systemic inflammation in patients with non-small cell lung cancer treated with immunotherapy or chemotherapy: A post hoc analysis of the phase 3 OAK trial. Cancer. 2022 Aug 15;128(16):3067-3079. doi: 10.1002/cncr.34348. Epub 2022 Jun 21.

Gadgeel S, Hirsch FR, Kerr K, Barlesi F, Park K, Rittmeyer A, Zou W, Bhatia N, Koeppen H, Paul SM, Shames D, Yi J, Matheny C, Ballinger M, McCleland M, Gandara DR. Comparison of SP142 and 22C3 Immunohistochemistry PD-L1 Assays for Clinical Efficacy of Atezolizumab in Non-Small Cell Lung Cancer: Results From the Randomized OAK Trial. Clin Lung Cancer. 2022 Jan;23(1):21-33. doi: 10.1016/j.cllc.2021.05.007. Epub 2021 May 30.

Gandara D, Reck M, Moro-Sibilot D, Mazieres J, Gadgeel S, Morris S, Cardona A, Mendus D, Ballinger M, Rittmeyer A, Peters S. Fast progression in non-small cell lung cancer: results from the randomized phase III OAK study evaluating second-line atezolizumab versus docetaxel. J Immunother Cancer. 2021 Mar;9(3):e001882. doi: 10.1136/jitc-2020-001882.

Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

Chalabi M, Cardona A, Nagarkar DR, Dhawahir Scala A, Gandara DR, Rittmeyer A, Albert ML, Powles T, Kok M, Herrera FG; imCORE working group of early career investigators. Efficacy of chemotherapy and atezolizumab in patients with non-small-cell lung cancer receiving antibiotics and proton pump inhibitors: pooled post hoc analyses of the OAK and POPLAR trials. Ann Oncol. 2020 Apr;31(4):525-531. doi: 10.1016/j.annonc.2020.01.006. Epub 2020 Jan 16.

Morrissey KM, Marchand M, Patel H, Zhang R, Wu B, Phyllis Chan H, Mecke A, Girish S, Jin JY, Winter HR, Bruno R. Alternative dosing regimens for atezolizumab: an example of model-informed drug development in the postmarketing setting. Cancer Chemother Pharmacol. 2019 Dec;84(6):1257-1267. doi: 10.1007/s00280-019-03954-8. Epub 2019 Sep 21.

Gadgeel SM, Lukas RV, Goldschmidt J, Conkling P, Park K, Cortinovis D, de Marinis F, Rittmeyer A, Patel JD, von Pawel J, O'Hear C, Lai C, Hu S, Ballinger M, Sandler A, Gandhi M, Fehrenbacher L. Atezolizumab in patients with advanced non-small cell lung cancer and history of asymptomatic, treated brain metastases: Exploratory analyses of the phase III OAK study. Lung Cancer. 2019 Feb;128:105-112. doi: 10.1016/j.lungcan.2018.12.017. Epub 2018 Dec 19.

Bordoni R, Ciardiello F, von Pawel J, Cortinovis D, Karagiannis T, Ballinger M, Sandler A, Yu W, He P, Matheny C, Felizzi F, Rittmeyer A. Patient-Reported Outcomes in OAK: A Phase III Study of Atezolizumab Versus Docetaxel in Advanced Non-Small-cell Lung Cancer. Clin Lung Cancer. 2018 Sep;19(5):441-449.e4. doi: 10.1016/j.cllc.2018.05.011. Epub 2018 May 31.

Hida T, Kaji R, Satouchi M, Ikeda N, Horiike A, Nokihara H, Seto T, Kawakami T, Nakagawa S, Kubo T. Atezolizumab in Japanese Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer: A Subgroup Analysis of the Phase 3 OAK Study. Clin Lung Cancer. 2018 Jul;19(4):e405-e415. doi: 10.1016/j.cllc.2018.01.004. Epub 2018 Feb 1.

Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J, Gadgeel SM, Hida T, Kowalski DM, Dols MC, Cortinovis DL, Leach J, Polikoff J, Barrios C, Kabbinavar F, Frontera OA, De Marinis F, Turna H, Lee JS, Ballinger M, Kowanetz M, He P, Chen DS, Sandler A, Gandara DR; OAK Study Group. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017 Jan 21;389(10066):255-265. doi: 10.1016/S0140-6736(16)32517-X. Epub 2016 Dec 13. Erratum In: Lancet. 2017 Apr 8;389(10077):e5.

Layout table for additonal information

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT02008227
Other Study ID Numbers:	GO28915 2013-003331-30 ( EudraCT Number )
First Posted:	December 11, 2013 Key Record Dates
Results First Posted:	July 2, 2017
Last Update Posted:	December 20, 2019
Last Verified:	December 2019

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

Layout table for MeSH terms

Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms	Docetaxel Atezolizumab Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Immune Checkpoint Inhibitors Antineoplastic Agents, Immunological

To Top