A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 695
- 试验地点
- 318
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC).
The primary objectives of this study are to compare the effect of SG to SOC on overall survival (OS).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of SCLC.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by investigator per RECIST v1.1 criteria.
- •Documentation of radiological disease progression after 1 prior line of platinum-containing chemotherapy (defined as at least 2 cycles of treatment) with or without therapy directed against programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1; PD-1 and PD-L1 are hereafter referred to as PD-(L)1) for ES-SCLC.
- •Individuals treated with a platinum-based therapy for prior limited stage small cell lung cancer will be counted as 1 prior line of platinum-containing chemotherapy if the disease has progressed within 30 to 180 days from last dose of platinum treatment.
- •If the investigator believes a participant may benefit from platinum rechallenge it can be considered per investigator discretion and local SOC; however, participants with platinum rechallenge may not participate in the study.
- •If the investigator believes a participant may benefit from tarlatamab treatment, it can be considered per investigator discretion and local SOC and such participants may participate in the study following tarlatamab treatment.
- •Note: at least 85% of participants included in the study must be pretreated with anti-PD-[L]1 therapy.
- •Refer to protocol for country-specific requirements for participants in China.
排除标准
- •Chemotherapy-free interval (CTFI) time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) < 30 days (independent of the immunotherapy maintenance).
- •Received any prior treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives, and similar agents targeting topoisomerase I. Received lurbinectedin after progression on or after platinum-based chemotherapy.
- •Have carcinomatous meningitis and/or non-carcinomatous meningitis central nervous system (CNS) metastasis apart from the following noted exceptions. Participants with previously treated brain metastases may participate provided they have stable CNS disease (ie, without evidence of progression) for at least 4 weeks (independent from completion of definitive treatment) prior to randomization and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking ≤ 10 mg/day of prednisone or its equivalent. Participants with untreated, clinically stable brain metastases will be allowed if they are asymptomatic and the investigator determines there is no immediate CNS-specific treatment required, there is no surrounding edema, and the brain metastases are of 5 mm or less in size and 3 or fewer lesions.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Treatment Group A: SG
Participants assigned to treatment group A will receive SG 10 mg/kg intravenous (IV) infusion on Days 1 and 8 of a 21-day cycle. Participants will receive study drug until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.
干预措施: Sacituzumab Govitecan (SG) (Drug)
Treatment Group B: Topotecan, or Lurbinectedin, or Amrubicin
Participants assigned to Treatment Group B will receive one of the following investigator selected treatments within a 21 day cycle:
- Topotecan 1.5 mg/m² administered daily on Days 1 through 5, or
- Lurbinectedin 3.2 mg/m² administered as an intravenous infusion on Day 1 (in countries/regions where lurbinectedin is approved and available).
In Japan, participants assigned to Treatment Group B may alternatively receive:
• Amrubicin (available only in Japan) 40 mg/m² administered daily on Days 1 through 3 of a 21 day cycle.
Study treatment will continue until disease progression, death, unacceptable toxicity, or another protocol defined criterion for treatment discontinuation is met.
干预措施: Amrubicin (Japan only) (Drug)
Treatment Group B: Topotecan, or Lurbinectedin, or Amrubicin
Participants assigned to Treatment Group B will receive one of the following investigator selected treatments within a 21 day cycle:
- Topotecan 1.5 mg/m² administered daily on Days 1 through 5, or
- Lurbinectedin 3.2 mg/m² administered as an intravenous infusion on Day 1 (in countries/regions where lurbinectedin is approved and available).
In Japan, participants assigned to Treatment Group B may alternatively receive:
• Amrubicin (available only in Japan) 40 mg/m² administered daily on Days 1 through 3 of a 21 day cycle.
Study treatment will continue until disease progression, death, unacceptable toxicity, or another protocol defined criterion for treatment discontinuation is met.
干预措施: Lurbinectedin (regions/countries where approved and available) (Drug)
Treatment Group B: Topotecan, or Lurbinectedin, or Amrubicin
Participants assigned to Treatment Group B will receive one of the following investigator selected treatments within a 21 day cycle:
- Topotecan 1.5 mg/m² administered daily on Days 1 through 5, or
- Lurbinectedin 3.2 mg/m² administered as an intravenous infusion on Day 1 (in countries/regions where lurbinectedin is approved and available).
In Japan, participants assigned to Treatment Group B may alternatively receive:
• Amrubicin (available only in Japan) 40 mg/m² administered daily on Days 1 through 3 of a 21 day cycle.
Study treatment will continue until disease progression, death, unacceptable toxicity, or another protocol defined criterion for treatment discontinuation is met.
干预措施: Topotecan (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 4.5 years
OS is defined as length of time from randomization until the date of death from any cause.
次要结局
- Progression-free Survival (PFS)(Up to 4.5 years)
- Duration of Response (DOR)(Up to 4.5 years)
- Objective Response Rate (ORR)(Up to 4.5 years)
- Time to First Deterioration in Shortness of Breath Domain(Up to 4.5 years)
- Time to First Deterioration in Physical Functioning Domain(Up to 4.5 years)
- Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)(First dose date up to 4.5 years)
- Percentage of Participants Experiencing Clinical Laboratory abnormalities(First dose date up to 4.5 years)