Phase 3
Completed N=1,225
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
Source: ClinicalTrials.gov NCT02008227 ↗Enrolled (actual)
1,225
Serious AEs
32.0%
Results posted
Jul 2017
Primary outcomePrimary: Percentage of Participants Who Died: PP-ITT — 70.1; 63.8 Percentage of Participants
◆ Published Evidence
Established
30citations · ~8 / year
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.
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.
Linked Publications (5)
-
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.
-
Maximum Somatic Allele Frequency-Adjusted Blood-Based Tumor Mutational Burden Predicts the Efficacy of Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer.
-
Real-World Progression-Free Survival as an Endpoint in Lung Cancer: Replicating Atezolizumab and Docetaxel Arms of the OAK Trial Using Real-World Data.
-
Reciprocal regulation of hMENA and TGF-β signaling in cancer-associated fibroblasts promotes EMT, immunosuppression, poor prognosis, and ICT resistance in NSCLC.
-
Early C-reactive protein kinetics predicts immunotherapy response in non-small cell lung cancer in the phase III OAK trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Died: PP-ITT |
70.1; 63.8 | — |
| PRIMARY Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP |
67.1; 62.7 | — |
| PRIMARY Overall Survival (OS): PP-ITT |
9.6; 13.8 | 0.0003 sig |
| PRIMARY OS: TC1/2/3 or IC1/2/3 Subgroup of PP |
10.3; 15.7 | 0.0102 sig |
| PRIMARY OS: SP-ITT |
9.8; 13.3 | 0.0012 sig |
| PRIMARY OS: TC1/2/3 Or IC1/2/3 Subgroup of SP |
10.8; 14.3 | 0.0045 sig |
| PRIMARY OS: TC2/3 or IC2/3 Subgroup of SP |
11.4; 16.6 | 0.0012 sig |
| PRIMARY OS: TC3 or IC3 Subgroup of SP |
9.7; 20.5 | <0.0001 sig |
| SECONDARY 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 |
88.2; 89.4 | — |
| SECONDARY 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 |
86.9; 89.6 | — |
| SECONDARY Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT |
4.0; 2.8 | 0.4928 |
| SECONDARY PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP |
4.1; 2.8 | 0.3806 |
| SECONDARY Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT |
13.4; 13.6 | — |
| SECONDARY Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP |
16.2; 17.8 | — |
| SECONDARY Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT |
6.2; 16.3 | <0.0001 sig |
| SECONDARY DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP |
6.2; 16.0 | 0.0006 sig |
| SECONDARY Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab |
30.4 | — |
| SECONDARY Maximum Observed Serum Atezolizumab Concentration (Cmax) |
400 | — |
| SECONDARY Minimum Observed Serum Atezolizumab Concentration (Cmin) |
2.59; 83.2; 130; 158; 205; 226 | — |
| SECONDARY 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) |
8.3; 18.0; 5.6; 5.5; 2.1; 1.8 | 0.0111 sig |
| SECONDARY EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items |
26.58; 22.92; 27.49; 26.99; 21.35; 21.16 | — |
| SECONDARY EORTC QLQ-C30 Questionnaire Score: Functional Subscales |
83.38; 85.16; 83.38; 84.94; 84.05; 86.28 | — |
| SECONDARY EORTC QLQ-C30 Questionnaire Score: GHS Scale |
60.55; 61.24; 59.56; 58.93; 64.64; 64.61 | — |
| SECONDARY EORTC QLQ-C30 Questionnaire Score: Symptom Subscale |
8.01; 7.59; 11.50; 9.53; 7.05; 7.27 | — |
| SECONDARY EORTC QLQ-LC13 Questionnaire Score: Alopecia |
13.89; 14.32; 60.44; 6.63; 56.72; 7.44 | — |
| SECONDARY EORTC QLQ-LC13 Questionnaire Score: Coughing |
38.73; 37.27; 36.54; 37.50; 33.73; 33.89 | — |
| SECONDARY EORTC QLQ-LC13 Questionnaire Score: Dysphagia |
6.20; 5.09; 10.22; 6.42; 9.16; 5.43 | — |
| SECONDARY EORTC QLQ-LC13 Questionnaire Score: Dyspnea |
28.55; 26.78; 28.14; 28.79; 28.13; 25.40 | — |
| SECONDARY EORTC QLQ-LC13 Questionnaire Score: Hemoptysis |
4.32; 3.86; 4.76; 3.16; 4.38; 3.10 | — |
| SECONDARY EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder |
20.49; 20.16; 19.58; 18.34; 17.20; 16.44 | — |
| SECONDARY EORTC QLQ-LC13 Questionnaire Score: Pain in Chest |
17.92; 19.52; 16.67; 15.26; 14.59; 15.43 | — |
| SECONDARY EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy |
19.26; 19.21; 25.57; 20.02; 25.60; 17.78 | — |
| SECONDARY EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts |
27.52; 27.94; 29.58; 27.76; 22.87; 25.87 | — |
| SECONDARY EORTC QLQ-LC13 Questionnaire Score: Sore Mouth |
5.68; 4.95; 15.52; 7.10; 14.29; 5.61 | — |
| SECONDARY PFS as Determined by Investigator Using RECIST v1.1: SP-ITT |
3.8; 2.7 | 0.4981 |
| SECONDARY Percentage of Participants With Objective Response as Determined Using RECIST v1.1: SP-ITT |
11.8; 13.7 | — |
| SECONDARY DOR as Determined by Investigator Using RECIST v1.1: SP ITT |
6.3; 23.9 | — |
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
Data sourced from ClinicalTrials.gov (NCT02008227) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.