2025-522288-13-00招募中2 期
ETOP 29-25 START-lung: A multicentre phase II trial of tarlatamab in patients with pretreated extensive-stage small cell lung cancer (ES-SCLC) and ECOG PS 2.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 13
- 主要终点
- Overall survival rate at 12 months (12-month OS)
研究概览
简要总结
The primary objective of the trial is to assess the clinical efficacy of tarlatamab in terms of 12-month overall survival (OS) rate in patients with ES-SCLC and ECOG PS 2 who have previously received one line of platinum-etoposide doublet chemotherapy with an immune-checkpoint inhibitor and whose disease has progressed.
研究设计
- 分配方式
- Na
- 主要目的
- Follow-up after disease progression
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed ES-SCLC
- •Previous treatment with only one line of platinum-etoposide doublet chemotherapy with immune-checkpoint inhibition for SCLC
- •Progressive disease on or after the first-line treatment for SCLC
- •ECOG Performance Status 2
- •Age ≥18 years
- •Adequate organ function
- •Negative pregnancy test for female participants of childbearing potential
- •Written Informed Consent signed before any trial-related intervention
排除标准
- •Symptomatic CNS metastases
- •Diagnosis or evidence of leptomeningeal disease or spinal cord compression
- •Prior history of immune-related recurrent pneumonitis (grade ≥2)) or severe immune-mediated adverse events
- •Evidence of interstitial lung disease or active, non-infectious pneumonitis
- •Active autoimmune disease
- •History of solid organ transplantation
- •Presence or history of an uncontrolled viral infection
- •History of other malignancy within the past 2 years
研究组 & 干预措施
Tarlatamab, Tarlatamab
Test
干预措施: Tarlatamab (Drug)
结局指标
主要结局
Overall survival rate at 12 months (12-month OS)
Overall survival rate at 12 months (12-month OS)
次要结局
- Objective response rate (ORR) according to RECIST v1.1
- Duration of response (DoR)
- Disease control rate (DCR)
- Progression-free survival (PFS) according to RECIST v1.1
- Incidence, nature, and severity of adverse events according to CTCAE v5, except for CRS and ICANS, that are graded according to the ASTCT criteria and TLS that are graded according to the Cairo-Bishop classification
研究者
ETOP IBCSG Partners Foundation Regulatory Office
Scientific
ETOP IBCSG Partners Foundation
研究点 (13)
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