A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With Small Cell Lung Cancer (SCLC) (DeLLphi-309)

Amgen155 个研究点分布在 10 个国家目标入组 252 人2025年2月26日

适应症Small Cell Lung Cancer (SCLC)

干预措施Tarlatamab

概览

阶段: 2 期
干预措施: Tarlatamab
疾病 / 适应症: Small Cell Lung Cancer (SCLC)
发起方: Amgen
入组人数: 252
试验地点: 155
主要终点: Proportion of participants with confirmed objective response to Tarlatamab
状态: 进行中（未招募）
最后更新: 2个月前

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 primary objective of this study is to describe the antitumor activity of tarlatamab in participants with small cell lung cancer (SCLC).

注册库

clinicaltrials.gov

开始日期

2025年2月26日

结束日期

2029年2月9日

最后更新

2个月前

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 prior to initiation of any study specific activities/procedures.
•Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
•Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
•Participants who progressed or recurred following 1 platinum-based regimen.
•Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
•Eastern Cooperative Oncology Group (ECOG) PS of 0 or
•Minimum life expectancy of 12 weeks.
•Adequate organ function as described per protocol.

排除标准

•Disease Related
•Previous diagnosis of transformed non-small cell lung cancer (NSCLC) including epidermal growth factor receptor activating mutation positive NSCLC that has transformed to SCLC.
•Symptomatic central nervous system (CNS) metastases with exceptions defined in the protocol.
•Other Medical Conditions
•History of other malignancy within the past 2 years, with exceptions defined in the protocol.
•Evidence of interstitial lung disease or active, non-infectious pneumonitis
•Diagnosis or evidence of leptomeningeal disease.
•Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.
•History of solid organ transplantation.
•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

Treatment Arm A: Dose 1 Tarlatamab

Participants will receive dose 1 of Tarlatamab by intravenous (IV) infusion during the treatment period.

干预措施: Tarlatamab

Treatment Arm B: Dose 2 Tarlatamab

Participants will receive dose 2 of Tarlatamab by IV infusion during the treatment period.

干预措施: Tarlatamab

Treatment Arm C: Dose 3 Tarlatamab

Participants will receive dose 3 of Tarlatamab by IV infusion during the treatment period.

干预措施: Tarlatamab

结局指标

主要结局

Proportion of participants with confirmed objective response to Tarlatamab

时间窗: Approximately 52 Months

Proportion of participants with complete response to Tarlatamab

时间窗: Approximately 52 Months

Proportion of participants with partial response to Tarlatamab

时间窗: Approximately 52 Months

次要结局

Average serum concentrations of Tarlatamab(Approximately 52 Weeks)
Duration of confirmed response, defined as the time from the first documentation of OR until the first documentation of disease progression or death(Approximately 52 Months)
Disease control, defined as objective response or stable disease(Approximately 52 Months)
Duration of disease control(Approximately 52 Months)
Progression-free survival, defined as the time from randomization to the first documentation of disease progression or death due to any cause(Approximately 52 Months)
Objective response, defined as best overall response of CR or PR(Approximately 52 Months)
Overall survival, defined as the time from randomization to death due to any cause(Approximately 52 Months)
Overall Survival rate at 6 months and 1 year from randomization(Approximately 52 Months)
Number of participants with treatment-emergent adverse events(Approximately 52 Months)
Number of participants with anti-tarlatamab antibody formation(Approximately 52 Months)