A Phase III Study of atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed in Patients With Stage IV Non-squamous Non-small Cell Lung Cancer [IMpower132]

Phase 3

Completed

• Conditions: on-Small Cell Lung Cancer

• Registration Number: JPRN-jRCT2080223142
• Lead Sponsor: CHUGAI PHARMACEUTICAL CO., LTD.

Brief Summary

Atezolizumab plus pemetrexed and platinum chemotherapy offered longer PFS and a non-significant but numerically better OS compared with pemetrexed plus platinum- based chemotherapy in the first-line treatment of patients with non-squamous NSCLC, with a manageable safety profile.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-11
• Study Completion: 2020-06-25
• Results First Posted: 2020-12-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 578

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
-Histologically or cytologically confirmed, treatment-naieve Stage IV non-squamous NSCLC
-No prior treatment for Stage IV non-squamous NSCLC.
-Measurable disease as defined by RECIST v1.1
-Adequate hematologic and end organ function

Exclusion Criteria

-Participants with a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or with an anaplastic lymphoma kinase (ALK) fusion oncogene
-Active or untreated central nervous system (CNS) metastasis
-Malignancies other than NSCLC within 5 years prior to randomization
-Known tumor PD-L1 expression status from other clinical studies
-History of certain autoimmune disease
-History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
-History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds
-Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies
-Severe infection within 4 weeks prior to randomization
-Significant history of cardiovascular disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified