Phase 3
Completed N=1,021
A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]
Source: ClinicalTrials.gov NCT02367794 ↗Enrolled (actual)
1,021
Serious AEs
41.5%
Results posted
Nov 2019
Primary outcomePrimary: Progression Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population — 5.6; 6.5; 5.6 Months — p=0.0006
◆ Published Evidence
Established
24citations · ~6 / year
Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data.
Summary
This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.
Linked Publications
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Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population |
5.6; 6.5; 5.6 | 0.0006 sig |
| PRIMARY Overall Survival (OS) in the ITT Population |
13.5; 14.2; 12.6 | 0.1581 |
| SECONDARY OS in the in the Teff Population |
16.4; 17.4; 15.2; 12.4; 13.0; 10.5 | 0.4451 |
| SECONDARY PFS as Determined by the Investigator Using RECIST v1.1 in the Teff Population |
5.6; 7.0; 7.0; 5.7; 6.2; 5.5 | 0.0006 sig |
| SECONDARY PFS as Determined by the Investigator Using RECIST v1.1 in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population |
5.6; 8.4; 7.0 | <.0001 sig |
| SECONDARY PFS as Determined by the Investigator Using RECIST v1.1 in the TC1/2/3 or IC1/2/3 Population |
5.6; 7.1; 7.0 | <.0001 sig |
| SECONDARY OS in the TC2/3 or IC2/3 Population |
14.5; 20.4; 14.8 | 0.0518 |
| SECONDARY OS in the TC1/2/3 or IC1/2/3 Population |
15.0; 14.8; 14.9 | 0.2956 |
| SECONDARY Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population |
41.0; 49.7; 49.3 | 0.0248 sig |
| SECONDARY Duration of Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population |
5.2; 7.2; 7.0 | <.0001 sig |
| SECONDARY Event Free Rate at 1 and 2 Years in the ITT Population |
56.28; 56.34; 52.30; 26.58; 32.51; 27.79 | 0.9871 |
| SECONDARY Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population |
3.2; 4.2; 3.0 | 0.0461 sig |
| SECONDARY TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-LC13 Symptom Subscales in the ITT Population |
2.6; 3.4; 2.8 | 0.0942 |
| SECONDARY Change From Baseline in Patient-reported Lung Cancer Symptoms Score Using the SILC Scale Symptom Severity Score in the ITT Population |
0.04; 0.14; 0.44; -0.08; 0.09; 0.28 | — |
| SECONDARY PFS as Determined by the Investigator Using RECIST v1.1 in the ITT Population (Arm A and Arm B) |
6.5; 5.6 | 0.4007 |
| SECONDARY OS in the ITT Population (Arm A and Arm B) |
14.2; 12.6 | — |
| SECONDARY Percentage of Participants With Adverse Events |
97.0; 99.4; 97.9 | — |
| SECONDARY Percentage of Participants With Anti-therapeutic Antibody (ATA) Response to Atezolizumab |
3.1; 1.9; 48.1; 21.4 | — |
| SECONDARY Maximum Observed Serum Atezolizumab Concentration (Cmax) |
372; 378; 470; 444 | — |
| SECONDARY Minimum Observed Serum Atezolizumab Concentration (Cmin) |
NA; NA; 63.9; 69.5; 103; 107 | — |
| SECONDARY Plasma Concentrations for Paclitaxel |
NA; 5860; 2960; NA; 21900; 11000 | — |
| SECONDARY Plasma Concentrations for Nab-Paclitaxel |
NA; NA; 3330; 8160; 735; 921 | — |
| SECONDARY Plasma Concentrations for Carboplatin |
NA; NA; NA; 21100; 15900; 24900 | — |
Eligibility Criteria
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC
- Previously obtained archival tumor tissue or tissue obtained from biopsy at screening
- Measurable disease as defined by RECIST v1.1
- Adequate hematologic and end organ function
Exclusion Criteria
- Active or untreated central nervous system (CNS) metastasis
- Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
- Pregnant or lactating women
- History of autoimmune disease
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computed Tomography (CT) scan, History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- Positive test for Human Immunodeficiency Virus (HIV)
- Active hepatitis B or hepatitis C
- Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody
- Severe infection within 4 weeks prior to randomization
- Significant history of cardiovascular disease
Data sourced from ClinicalTrials.gov (NCT02367794) 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.