A phase II study of carboplatin and etopside plus durvalumab for previously-untreated extensive-stage small-cell lung cancer (ES-ECLC) patients with poor performance status (PS) - NEJ045A
- Conditions
- extensive disease small cell lung cancer
- Registration Number
- JPRN-jRCTs031200319
- Lead Sponsor
- Watanabe Satoshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 56
1) Extensive stage small cell lung cancer proven by histology and/or cytology without indication of curative surgery or curative radiotherapy, 2) No prior cytotoxic chemotherapy or immunotherapy, 3) ECOG PS 2 or 3, 4) 20 years or older, 5)Measurable disease, as defined by RECIST ver 1.1, 6) adequate hematologic and end organ function,7) Written informed consent form.
1) History of interstitial lung disease, 2) Symptomatic CNS metastases, CNS metastases treated with corticosteroids, leptomeningeal disease, 3) Irradiation for primary tumor or target lesion defined by RECIST ver1.1, 4) Uncontrolled heart, lung, liver, renal diseases, 5) History of autoimmune diseases or immunodeficiency, 6) Patients with active hepatitis B or hepatitis C or positive for HIV test, 7) Men without an intention to use the measure for contraception or women who are pregnant, lactating, or intending to become pregnant during the study, 8) Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, 9) Malignancies other than NSCLC within 5 years, 10) Systemic steroid administration at a dose of more than 10 mg of prednisolone for 4 weeks or longer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tolerability of durvalumab, carboplatin and etoposide
- Secondary Outcome Measures
Name Time Method One year survival rate, safety, objective response rate, progression-free survival, overall survival, improvement rate of PS