Phase 3 Study of Chemotherapy with MK-7684A or Atezolizumab in First-Line ES-SCLC
- Conditions
- ES-SCLC
- Registration Number
- JPRN-jRCT2021220008
- Lead Sponsor
- Ishii Takeaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Has histologically or cytologically confirmed diagnosis of ES-SCLC in need of first-line therapy
-Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
-Males agree to use contraception, refrain from donating sperm, and abstain from heterosexual intercourse
-Females are not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or is a WOCBP who uses a highly effective contraceptive method, or is abstinent from heterosexual intercourse
-Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
-Has a predicted life expectancy of >3 months
-Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease
-Has received prior treatment for Small Cell Lung Cancer (SCLC)
-Is expected to require any other form of antineoplastic therapy for SCLC while on study
-Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
-Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
-Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
-Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
-Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
-Has a history of severe hypersensitivity reaction (>=Grade 3) to any study intervention and/or any of its excipients
-Has an active autoimmune disease that has required systemic treatment in past 2 years
-Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
-Has a known history of, or active, neurologic paraneoplastic syndrome
-Has an active infection requiring systemic therapy
-Has a known history of human immunodeficiency virus (HIV) infection
-Has a known history of Hepatitis B or known active Hepatitis C virus infection
-Has had an allogenic tissue/solid organ transplant
-Has had major surgery within prior 3 weeks or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study intervention
-Has symptomatic ascites or pleural effusion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival (OS)
- Secondary Outcome Measures
Name Time Method