NCT07005128进行中（未招募）3 期
A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in Combination With Durvalumab, Carboplatin and Etoposide Versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen
- 入组人数
- 350
- 试验地点
- 411
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The main objective of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has provided informed consent before initiation of any study-specific activities/procedures.
- •Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years.
- •Histologically or cytologically documented ES-SCLC (American Joint Committee on Cancer, 2017, Stage IV SCLC [T any, N any, M1 a/b/c]), or T3 to 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.
- •Measurable disease as defined per RECIST 1.
- •Suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment.
- •Minimum life expectancy ≥ 12 weeks.
排除标准
- •Participants can have no history of other malignancy in the last 2 years.
- •Any symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.
- •They will have no history of severe or life-threatening events to immune-mediated therapy.
- •History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
- •They will have no active autoimmune or inflammatory disorders.
- •Presence of active human immunodeficiency virus (HIV) or active Hepatitis (B/C) infection.
- •Evidence or interstitial lung disease (ILD) or active, non-infectious pneumonitis.
- •History of solid organ transplant.
- •They will not have had a myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment.
研究组 & 干预措施
Tarlatamab + Durvalumab + Carboplatin + Etoposide
Experimental
Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.
干预措施: Carboplatin (Drug)
Durvalumab + Carboplatin + Etoposide
Active Comparator
Participants will receive durvalumab, carboplatin and etoposide for 4 cycles followed by durvalumab.
干预措施: Durvalumab (Drug)
Tarlatamab + Durvalumab + Carboplatin + Etoposide
Experimental
Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.
干预措施: Tarlatamab (Drug)
Tarlatamab + Durvalumab + Carboplatin + Etoposide
Experimental
Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.
干预措施: Etoposide (Drug)
Durvalumab + Carboplatin + Etoposide
Active Comparator
Participants will receive durvalumab, carboplatin and etoposide for 4 cycles followed by durvalumab.
干预措施: Etoposide (Drug)
Durvalumab + Carboplatin + Etoposide
Active Comparator
Participants will receive durvalumab, carboplatin and etoposide for 4 cycles followed by durvalumab.
干预措施: Carboplatin (Drug)
Tarlatamab + Durvalumab + Carboplatin + Etoposide
Experimental
Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.
干预措施: Durvalumab (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to approximately 3.5 years
Progression free survival (PFS) (Blinded Independent Central Review [BICR] Assessed)
时间窗: Up to approximately 3.5 years
次要结局
- Disease Control(Up to approximately 4 years)
- Duration of Response (DOR)(Up to approximately 4 years)
- PFS Rate(6 months, 1 year, and 2 years)
- OS Rate(6 months, 1 year, 2 years and 3 years)
- Time to Progression(Up to approximately 4 years)
- Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)(Up to approximately 4 years)
- Number of Participants Who Experience Treatment-related Adverse Events(Up to approximately 4 years)
- Number of Participants Who Experience Events of Interest(Up to approximately 4 years)
- Serum Concentrations of Tarlatamab(Up to approximately 1 year)
- Number of Participant Who Develop Anti-Tarlatamab Antibodies(Up to 13 months)
- PFS (Investigator Assessed)(Up to approximately 4 years)
- Objective Response (OR)(Up to approximately 4 years)
- Disease Control(Up to approximately 4 years)
- Duration of Response (DOR)(Up to approximately 4 years)
- PFS Rate(6 months, 1 year, and 2 years)
- OS Rate(6 months, 1 year, 2 years and 3 years)
- Time to Progression(Up to approximately 4 years)
- Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)(Up to approximately 4 years)
- Number of Participants Who Experience Treatment-related Adverse Events(Up to approximately 4 years)
- Number of Participants Who Experience Events of Interest(Up to approximately 4 years)
- Serum Concentrations of Tarlatamab(Up to approximately 1 year)
- Number of Participant Who Develop Anti-Tarlatamab Antibodies(Up to 13 months)
研究者
研究点 (411)
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