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)

• ClinicalTrials.gov Identifier: NCT02008227
• Recruitment Status: Completed
• First Posted: December 11, 2013
• Results First Posted: July 2, 2017
• Last Update Posted: December 20, 2019
• Sponsor: Hoffmann-La Roche
• 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

• 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

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 :

1. Percentage of Participants Who Died: PP-ITT [ Time Frame: Baseline until death due to any cause (up to approximately 2.25 years) ]
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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 :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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]) ]
10. 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) ]
11. 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) ]
12. 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.
13. 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).
14. 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).
15. 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).
16. 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).
17. 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.
18. 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.
19. 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.
20. 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.
21. 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.
22. 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.
23. 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.
24. 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.
25. 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.
26. 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.
27. 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.
28. 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.
29. 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

• 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

Locations

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

• 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.

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

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

Additional relevant 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