Multicenter, Phase II/III Study of Carboplatin Plus Etoposide With AL3810 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 313
- 试验地点
- 1
- 主要终点
- Phase II:adverse event(AE)/serious adverse event(SAE)
研究概览
简要总结
Phase II Study is to Evaluate the Safety and tolerability of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.
Phase III Study is to Evaluate the efficacy of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form
- •Male or female, 18 ~75years of age
- •Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
- •Histologically or cytologically confirmed ES-SCLC
- •No prior treatment for ES-SCLC
- •Measurable disease, as defined by RECIST v1.1
- •Adequate hematologic and end organ function.
- •Serum pregnancy test in screening period for women of childbearing potential should be negative.Except for women who have a history of sterilization or are postmenopausal.Men or woman subjects of reproductive age and their partners must agree to use effective contraception for at least 6 months from the date of signing the Informed Consent Form(ICF) until the last dose of the investigational therapy.
- •exclusion criteria: main exclusion criteria
- •Histologically confirmed mixed small cell lung cancer.
- •Symptoms related to central nervous system(CNS) metastasis, unstable CNS metastasis, or CNS diseases needed the increase of steroid dosage to control.
- •Uncontrolled hypertension.
排除标准
- 未提供
研究组 & 干预措施
Dose escalation (AL3810 + carboplatin + etoposide)
Phase II:Participants will receive AL3810 orally in combination with carboplatin and etoposide during the Cycles 1-4 . AL3810 dose escalated form 5mg to 10mg step-up to determine the recommended dose of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.
干预措施: AL3810 (Drug)
Dose escalation (AL3810 + carboplatin + etoposide)
Phase II:Participants will receive AL3810 orally in combination with carboplatin and etoposide during the Cycles 1-4 . AL3810 dose escalated form 5mg to 10mg step-up to determine the recommended dose of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.
干预措施: carboplatin + etoposide (Drug)
AL3810+ carboplatin + etoposide
Phase III:Participants will receive AL3810(recommended dose will be determined by safety monitoring committee (SMC) in Phase II) orally in combination with carboplatin and etoposide during the Cycles 1-4. Thereafter, participants will receive maintenance AL3810 until persistent radiographic PD, intolerable toxicity or withdrawal of consent, investigator's consideration, lost follow up, death ,study termination by the sponsor.whichever occurs first.
干预措施: AL3810 (Drug)
AL3810+ carboplatin + etoposide
Phase III:Participants will receive AL3810(recommended dose will be determined by safety monitoring committee (SMC) in Phase II) orally in combination with carboplatin and etoposide during the Cycles 1-4. Thereafter, participants will receive maintenance AL3810 until persistent radiographic PD, intolerable toxicity or withdrawal of consent, investigator's consideration, lost follow up, death ,study termination by the sponsor.whichever occurs first.
干预措施: carboplatin + etoposide (Drug)
Placebo+ carboplatin + etoposide
Phase III:Participants will receive placebo orally in combination with carboplatin and etoposide during the induction Cycles 1-4. Thereafter, participants will receive maintenance placebo until persistent radiographic PD, intolerable toxicity or withdrawal of consent, investigator's consideration, lost follow up, death ,study termination by the sponsor.whichever occurs first.
干预措施: carboplatin + etoposide (Drug)
Placebo+ carboplatin + etoposide
Phase III:Participants will receive placebo orally in combination with carboplatin and etoposide during the induction Cycles 1-4. Thereafter, participants will receive maintenance placebo until persistent radiographic PD, intolerable toxicity or withdrawal of consent, investigator's consideration, lost follow up, death ,study termination by the sponsor.whichever occurs first.
干预措施: Placebo (Drug)
结局指标
主要结局
Phase II:adverse event(AE)/serious adverse event(SAE)
时间窗: From the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
AE/SAE to find the recommended dose of AL3810
Phase III:1.PFS
时间窗: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 56 months
1. Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1
次要结局
未报告次要终点