TriangleNCT02008227 · CITED IN SOURCE DOCUMENTS
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
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2019-12-20
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Percentage of Participants Who Died: PP-ITT
Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP
Overall Survival (OS): PP-ITT
OS: TC1/2/3 or IC1/2/3 Subgroup of PP
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
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
Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT
PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT
DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
Maximum Observed Serum Atezolizumab Concentration (Cmax)
Minimum Observed Serum Atezolizumab Concentration (Cmin)
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)
EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
EORTC QLQ-C30 Questionnaire Score: Functional Subscales
EORTC QLQ-C30 Questionnaire Score: GHS Scale
EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
EORTC QLQ-LC13 Questionnaire Score: Alopecia
EORTC QLQ-LC13 Questionnaire Score: Coughing
EORTC QLQ-LC13 Questionnaire Score: Dysphagia
EORTC QLQ-LC13 Questionnaire Score: Dyspnea
EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
OS: SP-ITT
OS: TC1/2/3 Or IC1/2/3 Subgroup of SP
OS: TC2/3 or IC2/3 Subgroup of SP
OS: TC3 or IC3 Subgroup of SP
PFS as Determined by Investigator Using RECIST v1.1: SP-ITT
Percentage of Participants With Objective Response as Determined Using RECIST v1.1: SP-ITT
DOR as Determined by Investigator Using RECIST v1.1: SP ITT
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- 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.
- intervention Names
- Drug: Atezolizumab
- label
- Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
- type
- EXPERIMENTAL
- description
- 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.
- intervention Names
- Drug: Docetaxel
- label
- Docetaxel
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
- description
- 1200 mg IV infusion on Day 1 of each 21-day cycle
- name
- Atezolizumab
- other Names
- Tecentriq
- type
- DRUG
- arm Group Labels
- Docetaxel
- description
- 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle
- name
- Docetaxel
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 1225
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Percentage of Participants Who Died: PP-ITT
- time Frame
- Baseline until death due to any cause (up to approximately 2.25 years)
- description
- 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.
- measure
- 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)
- description
- 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.
- measure
- Overall Survival (OS): PP-ITT
- time Frame
- Baseline until death due to any cause (up to approximately 2.25 years)
- description
- 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.
- measure
- 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)
- description
- 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.
- measure
- OS: SP-ITT
- time Frame
- Baseline until death due to any cause (up to approximately 2.87 years)
- description
- 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.
- measure
- OS: TC1/2/3 Or IC1/2/3 Subgroup of SP
- time Frame
- Baseline until death from any cause (approximately 2.87 years)
- description
- 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.
- measure
- OS: TC2/3 or IC2/3 Subgroup of SP
- time Frame
- Baseline until death due to any cause (up to approximately 2.87 years)
- description
- 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.
- measure
- OS: TC3 or IC3 Subgroup of SP
- time Frame
- Baseline until death due to any cause (up to approximately 2.87 years)
- secondary Outcomes
- description
- 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.
- measure
- 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)
- description
- 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.
- measure
- 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)
- description
- 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.
- measure
- 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)
- description
- 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.
- measure
- 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)
- description
- 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.
- measure
- 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)
- description
- 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.
- measure
- 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)
- description
- 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.
- measure
- 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)
- description
- 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.
- measure
- 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)
- measure
- 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])
- measure
- 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)
- measure
- 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)
- description
- 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.
- measure
- 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)
Full 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.
Source references
- references
- citation
- Melchionna R, Di Modugno F, Di Carlo A, D'Ambrosio L, Palermo B, Tocci A, Paolini F, Sperduti I, Campo G, Taje R, Gallina F, Visca P, D'Andrea D, Nistico P. Reciprocal regulation of hMENA and TGF-beta signaling in cancer-associated fibroblasts promotes EMT, immunosuppression, poor prognosis, and ICT resistance in NSCLC. J Immunother Cancer. 2026 Jan 27;14(1):e013098. doi: 10.1136/jitc-2025-013098.
- pmid
- 41592891
- type
- DERIVED
- citation
- Mhatre SK, Machado RJM, Ton TGN, Trinh H, Mazieres J, Rittmeyer A, Bretscher MT. Real-World Progression-Free Survival as an Endpoint in Lung Cancer: Replicating Atezolizumab and Docetaxel Arms of the OAK Trial Using Real-World Data. Clin Pharmacol Ther. 2023 Dec;114(6):1313-1322. doi: 10.1002/cpt.3045. Epub 2023 Sep 28.
- pmid
- 37696652
- type
- DERIVED
- citation
- Saal J, Bald T, Eckstein M, Ritter M, Brossart P, Ellinger J, Holzel M, Klumper N. Early C-reactive protein kinetics predicts immunotherapy response in non-small cell lung cancer in the phase III OAK trial. JNCI Cancer Spectr. 2023 Mar 1;7(2):pkad027. doi: 10.1093/jncics/pkad027.
- pmid
- 37004206
- type
- DERIVED
- citation
- Dong Y, Zhu Y, Zhuo M, Chen X, Xie Y, Duan J, Bai H, Hao S, Yu Z, Yi Y, Guan Y, Yuan J, Xia X, Yi X, Wang J, Wang Z. Maximum Somatic Allele Frequency-Adjusted Blood-Based Tumor Mutational Burden Predicts the Efficacy of Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer. Cancers (Basel). 2022 Nov 17;14(22):5649. doi: 10.3390/cancers14225649.
- pmid
- 36428744
- type
- DERIVED
- citation
- 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.
- pmid
- 35727053
- type
- DERIVED
- citation
- 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.
- pmid
- 34226144
- type
- DERIVED
- citation
- 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.
- pmid
- 33737340
- type
- DERIVED
- citation
- 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.
- pmid
- 33241650
- type
- DERIVED
- citation
- 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.
- pmid
- 32115349
- type
- DERIVED
- citation
- 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.
- pmid
- 31542806
- type
- DERIVED
- citation
- 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.
- pmid
- 30642441
- type
- DERIVED
- citation
- 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.
- pmid
- 30017645
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- ure 4 Previously Treated Metastatic NSCLC OAK The efficacy of TECENTRIQ was evaluated in a multicenter, international, randomized (1:1), open-label study (OAK; NCT02008227) conducted in patients with locally advanced or metastatic NSCLC whose disease progressed during or following a platinum-containing regimen. Patients with a hi
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- Updated: May 15, 2025
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Preserved source evidence · Not medical advice