临床试验/NCT07005128

NCT07005128

招募中

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)

Amgen248 个研究点分布在 12 个国家目标入组 330 人2025年8月18日

干预措施Durvalumab Carboplatin Tarlatamab Etoposide

概览

阶段: 3 期
干预措施: Durvalumab
疾病 / 适应症: 未指定
发起方: Amgen
入组人数: 330
试验地点: 248
主要终点: Overall Survival (OS)
状态: 招募中
最后更新: 8天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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).

注册库

clinicaltrials.gov

开始日期

2025年8月18日

结束日期

2029年7月15日

最后更新

8天前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Amgen

责任方

Sponsor

入排标准

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

Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.

干预措施: Durvalumab

Tarlatamab + Durvalumab + Carboplatin + Etoposide

Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.

干预措施: Carboplatin

Durvalumab + Carboplatin + Etoposide

Participants will receive durvalumab, carboplatin and etoposide for 4 cycles followed by durvalumab.

干预措施: Durvalumab

Tarlatamab + Durvalumab + Carboplatin + Etoposide

Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.

干预措施: Tarlatamab

Tarlatamab + Durvalumab + Carboplatin + Etoposide

Participants will receive tarlatamab in combination with durvalumab, carboplatin and etoposide for 4 cycles followed by tarlatamab and durvalumab.

干预措施: Etoposide

Durvalumab + Carboplatin + Etoposide

Participants will receive durvalumab, carboplatin and etoposide for 4 cycles followed by durvalumab.

干预措施: Carboplatin

Durvalumab + Carboplatin + Etoposide

Participants will receive durvalumab, carboplatin and etoposide for 4 cycles followed by durvalumab.

干预措施: Etoposide

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)