MedPath

Tecentriq_SCLC(1L)_Bev_comb[BEAT-SC]

Phase 3
Completed
Conditions
Extensive-stage Small Cell Lung Cancer
Registration Number
JPRN-jRCT2080224946
Lead Sponsor
Chugai Pharmaceutical Co., Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
completed
Sex
All
Target Recruitment
330
Inclusion Criteria

Histologically or cytologically confirmed ES-SCLC
- No prior treatment for ES-SCLC
- ECOG performance status of 0 or 1
- Measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end organ function

Exclusion Criteria

- Malignancies other than SCLC within the last 5 years
- 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 CT scan.
- Positive test for Human Immunodeficiency Virus (HIV)
- Active hepatitis B or hepatitis C
- Severe infections at the time of enrollment
- Significant cardiovascular disease
- Prior treatment with immune checkpoint blockade therapies, anti-PD1 and anti-PD-L1 therapeutic antibody

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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