Phase 3
Completed N=578
A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132)
Source: ClinicalTrials.gov NCT02657434 ↗Enrolled (actual)
578
Serious AEs
42.5%
Results posted
Oct 2020
Primary outcomePrimary: Progression Free Survival (PFS) as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) — 5.2; 7.7 Months — p=<0.0001
◆ Published Evidence
Highly cited
183citations · ~61 / year
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.
Summary
This is a randomized, Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed). The study will be conducted in two phases: Induction Phase and Maintenance Phase.
Linked Publications (3)
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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.
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Results from the IMpower132 China cohort: Atezolizumab plus platinum-based chemotherapy in advanced non-small cell lung cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) |
5.2; 7.7 | <0.0001 sig |
| PRIMARY Overall Survival (OS) |
13.6; 17.5 | 0.1559 |
| SECONDARY Overall Survival Rate at Year 1 |
55.04; 59.72 | 0.2606 |
| SECONDARY Overall Survival Rate Year 2 |
34.01; 39.13 | 0.2090 |
| SECONDARY Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) Assessed by the Investigator Using RECIST V1.1 |
37.4; 51.7; 62.6; 48.3 | 0.0005 sig |
| SECONDARY Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 |
6.4; 9.5 | 0.0024 sig |
| SECONDARY Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score |
-1.95; -1.39; -1.23; -4.71; 0.20; -6.33 | — |
| SECONDARY Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score |
-2.50; -3.41; -3.57; -9.82; -1.85; -8.29 | — |
| SECONDARY Change From Baseline in Patient-Reported Lung Cancer Symptoms as Reported Using the Symptoms in Lung Cancer (SILC) Scale Score |
0.20; 0.30; -0.01; 0.21; -0.05; 0.06 | — |
| SECONDARY Minimum Observed Serum Atezolizumab Concentration (Cmin) |
69.8; 115; 151; 221; 234; 257 | — |
| SECONDARY Maximum Observed Serum Atezolizumab Concentration (Cmax) |
403 | — |
| SECONDARY Plasma Concentrations for Carboplatin in Arm A(Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) |
NA; 14900; 12800; 220; 17900; 13900 | — |
| SECONDARY Plasma Concentrations for Cisplatin in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) |
NA; 3630; 2400; 290; 3020; 2740 | — |
| SECONDARY Plasma Concentrations for Pemetrexed in Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) |
NA; 86500; 43600; 1.83; 79400; 50100 | — |
| SECONDARY Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) of Atezolizumab |
1.8; 35.4 | — |
Eligibility Criteria
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed, Stage IV non-squamous NSCLC. Participants with tumors of mixed non-small cell histology (i.e., squamous and non-squamous) are eligible if the major histological component appears to be non-squamous
- No prior treatment for Stage IV non-squamous NSCLC. Participants with a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or with an anaplastic lymphoma kinase (ALK) fusion oncogene are excluded. Participants with unknown EGFR and ALK status require test results at screening from a local or central laboratory
- Participants who have received prior neo-adjuvant, radiotherapy, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last dose of chemotherapy and/or radiotherapy
- Participants should submit a pre-treatment tumor tissue sample if available before or within 4 weeks after enrollment. If tumor tissue is not available, participants are still eligible
- For participants enrolled in the extended China enrollment phase: current resident of mainland China, Hong Kong, or Taiwan and of Chinese ancestry
- Measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end organ function
- For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of less than ( = 2) weeks prior to randomization
- Leptomeningeal disease
- Uncontrolled tumor-related pain
- Uncontrolled or symptomatic hypercalcemia (greater than [>] 1.5 millimole/Liter ionized calcium or calcium >12 milligrams/deciliter or corrected serum calcium >upper limit of normal)
- Malignancies other than NSCLC within 5 years prior to randomization
- Known tumor programmed death-ligand 1 (PD-L1) expression status from other clinical studies (e.g., participants whose PD-L1 expression status was determined during screening for entry into a study with anti-PD-1 or anti-PD L1 antibodies but were not eligible are excluded)
General Medical Exclusions:
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- History of certain autoimmune disease
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
- All participants will be tested for human immunodeficiency virus (HIV) prior to the inclusion into the study and HIV-positive participants will be excluded from the clinical study
- Severe infections within 4 weeks prior to randomization
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
- Illness or condition that may interfere with a participant's capacity to understand, follow, and/or comply with study procedures
Exclusion Criteria Related to Medications and Chemotherapy:
- Prior treatment with EGFR inhibitors or ALK inhibitors
- Any approved anti-cancer therapy, including hormonal therapy within 21 days prior to initiation of study treatment
- Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents within 4 weeks prior to randomization
- Treatment with systemic immunosuppressive medications
Exclusion Criteria Related to Chemotherapy:
- History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds
- Participants with hearing impairment (cisplatin)
- Grade >=2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (
Data sourced from ClinicalTrials.gov (NCT02657434) 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.