JPRN-jRCT2080223142
Completed
Phase 3
A PHASE III,OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB (MPDL3280A, ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN OR CISPLATIN+PEMETREXED COMPARED WITH CARBOPLATIN OR CISPLATIN+PEMETREXED IN PATIENTS WHO ARE CHEMOTHERAPY-NAIVE AND HAVE STAGE IV NON-SQUAMOUS NON-SMALL CELL LUNG CANCER
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Enrollment
- 578
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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