NCT06581380尚未招募3 期
A Multicenter, Randomized, Positive-Controlled, Open-label, Phase 3 Study of JK-1201I Compared with Topotecan in Patients with Relapsed Extensive Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 394
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This study was designed to compare the efficacy and safety of JK-1201I with Topotecan in patients with relapsed extensive stage small cell lung cancer (ES SCLC).
详细描述
This is a multicenter, randomized, positive-controlled, open-label, phase 3 study comparing JK-1201I with topotecan in patients with Relapsed Extensive Stage Small Cell Lung Cancer that had relapsed or disease progression on or after platinum-based first-line chemotherapy.
Patients will be randomized by a ratio of 1:1 to receive JK-1201I or topotecan until disease progression.
of JK-1201I Compared with Topotecan in Patients With Relapsed Extensive Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy The primary objective of this study is to assess whether treatment with JK-1201I prolongs overall survival (OS) compared with treatment of topotecan among patients with relapsed ES SCLC.
The secondary objectives of the study are to further evaluate the efficacy, safety and population pharmacokinetics of JK-1201I.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all the following criteria to be eligible for randomization into the study:
- •Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
- •Male or female aged ≥18 years and ≤70 years.
- •Histologically or cytologically documented SCLC.
- •Has received prior therapy with only one prior platinum-based line as systemic therapy for ES SCLC and Disease progression on or after first-line platinum-based regimens (≤ 6 months).
- •Has at least 1 measurable lesion according to RECIST v1.
- •Has ECOG PS of ≤1.
排除标准
- •Participants who meet any of the following criteria will be disqualified from entering the study:
- •Hypersensitivity to any ingredient of JK-1201I and Topotecan.
- •Has received prior treatment with DNA topoisomerase I inhibitor agents.
- •Has received prior therapy with ≥2 line as systemic therapy for extensive-stage SCLC.
- •Chemotherapy-free interval within 4 weeks before the first use of the study drug. Radiotherapy with a limited field of radiation for palliation within 2 weeks before the first use of the study drug. Used biotherapy drugs within 2 weeks before the first use of the study drug.
- •Severe gastrointestinal illnesses as defined in the protocol within 6 months before the first use of the study drug.
- •Local symptoms of tumors requiring radiotherapy or surgical treatment as defined in the protocol.
- •Untreated or symptomatic brain metastases with exceptions defined in the protocol.
- •Severe pulmonary illnesses within 6 months before the first use of the study drug.
- •Uncontrolled hydrothorax and ascites.
- •Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 with exceptions defined in the protocol.
- •Severe infections within 4 weeks before the first use of the study drug.
结局指标
主要结局
Overall survival (OS)
时间窗: From the date of randomization to the date of death due to any cause; Up to approximately 3.5 years.
Overall survival is defined as the time interval from randomization to death due to any cause.
次要结局
- Objective Response Rate (ORR) Assessed by Independent Response Evaluation Committee (IREC) and Investigators(From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 3.5 years.)
- Disease Control Rate (DCR) Assessed by Independent Response Evaluation Committee (IREC) and Investigators(From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 3.5 years.)
- Duration of Response (DoR) Assessed by Independent Response Evaluation Committee (IREC) and Investigators(From the date of first documentation of confirmed response (CR or PR) to the first documentation of progressive disease or death due to any cause, whichever occurs first; Up to approximately 3.5 years.)
- Progression-free Survival (PFS) Assessed by Independent Response Evaluation Committee (IREC) and Investigators(From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 3.5 years.)
- Incidence and Grade of Participants with Adverse Events (AE)(From the date of first dose to the end of safety follow-up; Up to approximately 3.5 years)
- Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for JK-1201I, Irinotecan, SN38 and SN38G(Cycle 1 before infusion, and 12, 168, and 240 hours (hrs) post dose; every 2 cycles before infusion, and 12 hrs post dose thereafter up to 3.5 years (each cycle is 21 days))
- Pharmacokinetic Parameter Maximum Concentration for JK-1201I, Irinotecan, SN38 and SN38G(Cycle 1 before infusion, and 12, 168, and 240 hours (hrs) post dose; every 2 cycles before infusion, and 12 hrs post dose thereafter up to 3.5 years (each cycle is 21 days))
研究者
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