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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02008227




Registration number
NCT02008227
Ethics application status
Date submitted
6/12/2013
Date registered
11/12/2013
Date last updated
20/12/2019

Titles & IDs
Public title
A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy
Scientific title
A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy
Secondary ID [1] 0 0
2013-003331-30
Secondary ID [2] 0 0
GO28915
Universal Trial Number (UTN)
Trial acronym
OAK
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Docetaxel

Experimental: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody - Atezolizumab 1200 milligrams (mg) was administered via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.

Active comparator: Docetaxel - Docetaxel 75 milligrams per meter square (mg/m\^2) was administered via IV infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.


Treatment: Drugs: Atezolizumab
1200 mg IV infusion on Day 1 of each 21-day cycle

Treatment: Drugs: Docetaxel
75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Died: PP-ITT
Timepoint [1] 0 0
Baseline until death due to any cause (up to approximately 2.25 years)
Primary outcome [2] 0 0
Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP
Timepoint [2] 0 0
Baseline until death due to any cause (up to approximately 2.25 years)
Primary outcome [3] 0 0
Overall Survival (OS): PP-ITT
Timepoint [3] 0 0
Baseline until death due to any cause (up to approximately 2.25 years)
Primary outcome [4] 0 0
OS: TC1/2/3 or IC1/2/3 Subgroup of PP
Timepoint [4] 0 0
Baseline until death due to any cause (up to approximately 2.25 years)
Primary outcome [5] 0 0
OS: SP-ITT
Timepoint [5] 0 0
Baseline until death due to any cause (up to approximately 2.87 years)
Primary outcome [6] 0 0
OS: TC1/2/3 Or IC1/2/3 Subgroup of SP
Timepoint [6] 0 0
Baseline until death from any cause (approximately 2.87 years)
Primary outcome [7] 0 0
OS: TC2/3 or IC2/3 Subgroup of SP
Timepoint [7] 0 0
Baseline until death due to any cause (up to approximately 2.87 years)
Primary outcome [8] 0 0
OS: TC3 or IC3 Subgroup of SP
Timepoint [8] 0 0
Baseline until death due to any cause (up to approximately 2.87 years)
Secondary outcome [1] 0 0
Percentage of Participants With Disease Progression (PD) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death: PP-ITT
Timepoint [1] 0 0
Baseline up to PD or Death (up to approximately 2.25 years)
Secondary outcome [2] 0 0
Percentage of Participants With PD as Determined by Investigator Using RECIST v1.1 or Death: TC1/2/3 or IC1/2/3 Subgroup of PP
Timepoint [2] 0 0
Baseline up to PD or Death (up to approximately 2.25 years)
Secondary outcome [3] 0 0
Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT
Timepoint [3] 0 0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary outcome [4] 0 0
PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
Timepoint [4] 0 0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary outcome [5] 0 0
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT
Timepoint [5] 0 0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary outcome [6] 0 0
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
Timepoint [6] 0 0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary outcome [7] 0 0
Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT
Timepoint [7] 0 0
From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary outcome [8] 0 0
DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
Timepoint [8] 0 0
From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Secondary outcome [9] 0 0
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
Timepoint [9] 0 0
Baseline up to approximately 2.25 years (assessed at predose [Hour {Hr} 0] on Day 1 of Cycles 1, 2, 3, 4, 8, 16, then every 8 cycles up to end of treatment (EOT) [approximately 2.25 years]; 120 days after EOT [approximately 2.25 years] [1 Cycle=21 days])
Secondary outcome [10] 0 0
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Timepoint [10] 0 0
Predose (Hr 0), 30 minutes (min) post-infusion (infusion duration: 60 min) on Cycle 1 Day 1 (1 Cycle=21 days)
Secondary outcome [11] 0 0
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Timepoint [11] 0 0
Predose (Hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24, 32, EOT (approximately 2.25 years); 120 days after EOT (approximately 2.25 years) (1 Cycle=21 days)
Secondary outcome [12] 0 0
Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)
Timepoint [12] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)
Secondary outcome [13] 0 0
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Timepoint [13] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [14] 0 0
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Timepoint [14] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [15] 0 0
EORTC QLQ-C30 Questionnaire Score: GHS Scale
Timepoint [15] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [16] 0 0
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Timepoint [16] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [17] 0 0
EORTC QLQ-LC13 Questionnaire Score: Alopecia
Timepoint [17] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [18] 0 0
EORTC QLQ-LC13 Questionnaire Score: Coughing
Timepoint [18] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [19] 0 0
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Timepoint [19] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [20] 0 0
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Timepoint [20] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [21] 0 0
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Timepoint [21] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [22] 0 0
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Timepoint [22] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [23] 0 0
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Timepoint [23] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [24] 0 0
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Timepoint [24] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [25] 0 0
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Timepoint [25] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [26] 0 0
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Timepoint [26] 0 0
Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Secondary outcome [27] 0 0
PFS as Determined by Investigator Using RECIST v1.1: SP-ITT
Timepoint [27] 0 0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)
Secondary outcome [28] 0 0
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: SP-ITT
Timepoint [28] 0 0
Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)
Secondary outcome [29] 0 0
DOR as Determined by Investigator Using RECIST v1.1: SP ITT
Timepoint [29] 0 0
From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)

Eligibility
Key inclusion criteria
* Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC
* Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
* Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen or combined modality (e.g., chemoradiation) regimen with curative intent
* Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known active or untreated central nervous system (CNS) metastases
* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
* History of autoimmune disease
* History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
* Active hepatitis B or hepatitis C
* Prior treatment with docetaxel
* Prior treatment with cluster of differentiation 137 (CD137) agonists, anti-cytotoxic-T-lymphocyte-associated antigen 4 (anti-CTLA4), anti-programmed death-1 (anti-PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents

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



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/01/2019
Sample size
Target
Accrual to date
Final
1225
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Maine
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
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Montana
Country [11] 0 0
United States of America
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Nebraska
Country [12] 0 0
United States of America
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Nevada
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United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
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New Mexico
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
Rhode Island
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Argentina
State/province [24] 0 0
Córdoba
Country [25] 0 0
Argentina
State/province [25] 0 0
Provincia De Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Rosario
Country [27] 0 0
Austria
State/province [27] 0 0
Innsbruck
Country [28] 0 0
Austria
State/province [28] 0 0
Salzburg
Country [29] 0 0
Austria
State/province [29] 0 0
Vöcklabruck
Country [30] 0 0
Brazil
State/province [30] 0 0
RS
Country [31] 0 0
Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
Chile
State/province [34] 0 0
Recoleta
Country [35] 0 0
Chile
State/province [35] 0 0
Temuco
Country [36] 0 0
Chile
State/province [36] 0 0
Vina Del Mar
Country [37] 0 0
Finland
State/province [37] 0 0
Helsinki
Country [38] 0 0
Finland
State/province [38] 0 0
Oulu
Country [39] 0 0
Finland
State/province [39] 0 0
Tampere
Country [40] 0 0
France
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Avignon
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France
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Besancon
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France
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Bordeaux
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France
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Caen
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France
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Creteil
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France
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Grenoble
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France
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Le Mans
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France
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Lille
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France
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Marseille
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France
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Mulhouse
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France
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Paris
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France
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Pierre Benite
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France
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Pringy
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France
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Rennes
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France
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Strasbourg
Country [55] 0 0
France
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Suresnes
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France
State/province [56] 0 0
Toulon
Country [57] 0 0
France
State/province [57] 0 0
Toulouse
Country [58] 0 0
Germany
State/province [58] 0 0
Berlin
Country [59] 0 0
Germany
State/province [59] 0 0
Frankfurt
Country [60] 0 0
Germany
State/province [60] 0 0
Gauting
Country [61] 0 0
Germany
State/province [61] 0 0
Halle
Country [62] 0 0
Germany
State/province [62] 0 0
Heidelberg
Country [63] 0 0
Germany
State/province [63] 0 0
Hemer
Country [64] 0 0
Germany
State/province [64] 0 0
Immenhausen
Country [65] 0 0
Germany
State/province [65] 0 0
Köln
Country [66] 0 0
Germany
State/province [66] 0 0
Regensburg
Country [67] 0 0
Greece
State/province [67] 0 0
Athens
Country [68] 0 0
Greece
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Patras
Country [69] 0 0
Greece
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Thermi Thessalonikis
Country [70] 0 0
Guatemala
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Guatemala City
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Hungary
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Budapest
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Hungary
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Pecs
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Hungary
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Torokbalint
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Friuli-Venezia Giulia
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Puglia
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Italy
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Sicilia
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Italy
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Toscana
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Italy
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Veneto
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Hyogo
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Japan
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Miyagi
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Japan
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Okayama
Country [91] 0 0
Japan
State/province [91] 0 0
Osaka
Country [92] 0 0
Japan
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Saitama
Country [93] 0 0
Japan
State/province [93] 0 0
Shizuoka
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Japan
State/province [94] 0 0
Tokyo
Country [95] 0 0
Japan
State/province [95] 0 0
Yamaguchi
Country [96] 0 0
Korea, Republic of
State/province [96] 0 0
Gyeonggi-do
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Korea, Republic of
State/province [97] 0 0
Seoul
Country [98] 0 0
Netherlands
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'S Hertogenbosch
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Netherlands
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Eindhoven
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Netherlands
State/province [100] 0 0
Nieuwegein
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New Zealand
State/province [101] 0 0
Auckland
Country [102] 0 0
New Zealand
State/province [102] 0 0
Dunedin
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New Zealand
State/province [103] 0 0
Hamilton
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Norway
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Oslo
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Panama
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Panama
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Poland
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Gdansk
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Poland
State/province [107] 0 0
Lodz
Country [108] 0 0
Poland
State/province [108] 0 0
Otwock
Country [109] 0 0
Poland
State/province [109] 0 0
Poznan
Country [110] 0 0
Poland
State/province [110] 0 0
Warszawa
Country [111] 0 0
Portugal
State/province [111] 0 0
Coimbra
Country [112] 0 0
Portugal
State/province [112] 0 0
Lisboa
Country [113] 0 0
Portugal
State/province [113] 0 0
Porto
Country [114] 0 0
Russian Federation
State/province [114] 0 0
Moscow
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Russian Federation
State/province [115] 0 0
Saint-Petersburg
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Samara
Country [117] 0 0
Serbia
State/province [117] 0 0
Belgrade
Country [118] 0 0
Serbia
State/province [118] 0 0
Sremska Kamenica
Country [119] 0 0
Spain
State/province [119] 0 0
LAS Palmas
Country [120] 0 0
Spain
State/province [120] 0 0
Madrid
Country [121] 0 0
Spain
State/province [121] 0 0
La Coruña
Country [122] 0 0
Spain
State/province [122] 0 0
Malaga
Country [123] 0 0
Spain
State/province [123] 0 0
Zaragoza
Country [124] 0 0
Sweden
State/province [124] 0 0
Goeteborg
Country [125] 0 0
Sweden
State/province [125] 0 0
Linköping
Country [126] 0 0
Sweden
State/province [126] 0 0
Stockholm
Country [127] 0 0
Switzerland
State/province [127] 0 0
Baden
Country [128] 0 0
Switzerland
State/province [128] 0 0
Geneve
Country [129] 0 0
Switzerland
State/province [129] 0 0
Luzern
Country [130] 0 0
Taiwan
State/province [130] 0 0
Taichung
Country [131] 0 0
Taiwan
State/province [131] 0 0
Taipei
Country [132] 0 0
Taiwan
State/province [132] 0 0
Taoyuan
Country [133] 0 0
Thailand
State/province [133] 0 0
Bangkok
Country [134] 0 0
Turkey
State/province [134] 0 0
Istanbul
Country [135] 0 0
Turkey
State/province [135] 0 0
Izmir
Country [136] 0 0
Ukraine
State/province [136] 0 0
Dnipropetrovsk
Country [137] 0 0
Ukraine
State/province [137] 0 0
Kharkiv
Country [138] 0 0
Ukraine
State/province [138] 0 0
Uzhgorod
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Grimsby
Country [140] 0 0
United Kingdom
State/province [140] 0 0
London
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Manchester
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Sutton in Ashfield

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

Ethics approval
Ethics application status

Summary
Brief summary
This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 \[anti-PD-L1\] antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.
Trial website
https://clinicaltrials.gov/study/NCT02008227
Trial related presentations / publications
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. doi: 10.1016/S0140-6736(17)30904-2.
Public notes

Contacts
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Hoffmann-La Roche
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02008227