Phase 3
Completed N=723
A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Carcinoma, Non-Squamous Non-Small Cell Lung
Source: ClinicalTrials.gov NCT02367781 ↗
Enrolled (actual)
723
Serious AEs
48.1%
Results posted
Apr 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 ITT-WT Population — 7.0; 5.5 Months — p=<.0001
◆ Published Evidence
Highly cited
1,694citations · ~242 / year
Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial.
Summary
This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants were randomized in a 2:1 ratio to Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).
Linked Publications (3)
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Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial.
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Association of Immune-Related Adverse Events With Efficacy of Atezolizumab in Patients With Non-Small Cell Lung Cancer: Pooled Analyses of the Phase 3 IMpower130, IMpower132, and IMpower150 Randomized Clinical Trials.
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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 ITT-WT Population |
7.0; 5.5 | <.0001 sig |
| PRIMARY Overall Survival (OS) in the ITT-WT Population |
18.6; 13.9 | 0.0298 sig |
| SECONDARY PFS as Determined by the Investigator Using Recist v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population |
7.0; 5.6; 7.5; 5.7; 7.5; 5.9 | <0.0001 sig |
| SECONDARY OS as Determined by the Investigator Using Recist v1.1 in the ITT Population |
17.0; 13.5 | 0.0732 |
| SECONDARY OS as Determined by the Investigator Using RECIST v1.1 in the PD-L1 Expression Population and PD-L1 Expression WT Population |
21.2; 16.9; 21.2; 16.9 | 0.0830 |
| SECONDARY Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT-WT Population |
60.2; 41.0 | <.0001 sig |
| SECONDARY Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population |
59.1; 42.2; 65.6; 46.2; 64.6; 45.0 | <.0001 sig |
| SECONDARY Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 in ITT-WT Population, ITT Population, and PD-L1 Expression Population and PD-L1 Expression WT Population |
6.2; 5.4; 6.7; 5.4; 7.2; 5.0 | 0.0002 sig |
| SECONDARY Event Free Rate (%) at Year 1 and 2 in ITT-WT Population and ITT Population |
62.02; 54.56; 40.43; 32.36; 61.65; 54.47 | 0.0647 |
| SECONDARY Event Free Rate (%) at Year 1 and 2 in PD-L1 Expression Population and PD-L1 Expression WT Population |
68.56; 61.86; 44.63; 35.98; 68.84; 62.51 | 0.2385 |
| SECONDARY Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms in the ITT-WT Population |
2.2; 1.9 | 0.3342 |
| SECONDARY Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale |
0.19; 0.14; -0.02; 0.03; -0.05; 0.01 | — |
| SECONDARY Percentage of Participants With Adverse Events |
99.6; 98.7 | — |
| SECONDARY Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab |
3.1; 4.8; 22.4; 23.5 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of Atezolizumab for Patients in Atezolizumab+Carboplatin+Nab-Paclitaxel Arm |
392; 454 | — |
| SECONDARY Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Atezolizumab+Carboplain+Nab-Paclitaxel |
70.9; 111; 134; 218 | — |
| SECONDARY Plasma Concentrations of Carboplatin |
NA; NA; 20,500; 17,000; 11,900; 12,400 | — |
| SECONDARY Plasma Concentrations of Nab-Paclitaxel Reported as Total Paclitaxel |
NA; NA; 3520; 2530; 307; 417 | — |
Eligibility Criteria
Inclusion Criteria
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
- Participants with no prior treatment for Stage IV non-squamous NSCLC
- Previously obtained archival tumor tissue or tissue obtained from fresh biopsy at screening
- Measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end organ function
Exclusion Criteria
Cancer-Specific Exclusions:
- Active or untreated central nervous system metastases
- 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
General Medical Exclusions:
- 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 scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- Positive test for human immunodeficiency virus
- Active hepatitis B or hepatitis C
- Severe infection within 4 weeks prior to randomization
- Significant cardiovascular disease
- Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures
Exclusion Criteria Related to Medications:
- Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies
Data sourced from ClinicalTrials.gov (NCT02367781) 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.