JPRN-jRCT2021220008进行中（未招募）3 期
A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination with Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination with Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants with Extensive-Stage Small Cell Lung Cancer
Ishii Takeaki0 个研究点目标入组 30 人开始时间: 2022年6月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •-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
研究者
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