JPRN-jRCT2080224946
Completed
Phase 3
A Phase III, double blind, randomized study of Bevacizumab in combination with Carboplatin or Cisplatin + Etoposide + Atezolizumab compared with Carboplatin or Cisplatin + Etoposide + Atezolizumab in patients with untreated ES-SCLC
Overview
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 330
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
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
Investigators
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