A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tarlatamab Therapy in Subjects With Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Who Have Not Progressed Following Concurrent Chemoradiation Therapy

Amgen513 个研究点分布在 8 个国家目标入组 404 人2024年2月20日

干预措施Tarlatamab Placebo

概览

阶段: 3 期
干预措施: Tarlatamab
疾病 / 适应症: 未指定
发起方: Amgen
入组人数: 404
试验地点: 513
主要终点: PFS as Determined by BICR
状态: 进行中（未招募）
最后更新: 3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相关资讯

概览

简要总结

The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS) based on blinded independent central review (BCIR) per response evaluation criteria in solid tumors v1.1 (RECIST 1.1) and on prolonging overall survival (OS).

注册库

clinicaltrials.gov

开始日期

2024年2月20日

结束日期

2030年4月20日

最后更新

3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

•Participants are eligible to be included in the study only if all of the following criteria apply:
•Participant has provided informed consent prior to 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 confirmed small-cell lung cancer (SCLC).
•Diagnosed and treated for LS-SCLC with concurrent chemotherapy and radiotherapy.
•Has completed chemoradiotherapy without progression per RECIST 1.1 (ie, achieved complete response \[CR\], partial response \[PR\], or stable disease \[SD\]).
•Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or
•Minimum life expectancy of 12 weeks.
•Adequate organ function.
•Toxicities attributed to concurrent chemoradiotherapy resolved to grade ≤ 1, unless otherwise specified. Excluding alopecia or fatigue.

排除标准

•Participants are excluded from the study if any of the following criteria apply:
•Disease Related
•Extensive-stage SCLC (ES-SCLC).
•Any previous diagnosis of transformed non-small-cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology.
•Evidence of interstitial lung disease or active, non-infectious pneumonitis. Other Medical Conditions
•History of other malignancy within the past 2 years, with certain exceptions.
•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.
•History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
•Exclusion of human immunodeficiency virus (HIV) or active hepatitis infection based on criteria per protocol.

研究组 & 干预措施

Tarlatamab

Participants will receive tarlatamab on Cycle 1 Day 1, 8 and 15, and once every 2 weeks (Q2W) thereafter (cycle is 28 days).

干预措施: Tarlatamab

Placebo

Participants will receive placebo on Cycle 1 Day 1, 8 and 15, and Q2W thereafter (cycle is 28 days).

干预措施: Placebo

结局指标

主要结局

PFS as Determined by BICR

时间窗: Up to approximately 6 years

OS Over the Whole Trial

时间窗: Up to approximately 6 years

次要结局

PFS Determined by Investigator Assessment(Up to approximately 6 years)
PFS at 6 months, 1 year, 2 years(6 months, 1 year, 2 years)
OS at 6 months, 1 year, 2 years, 3 years(6 months, 1 year, 2 years, 3 years)
Time to Progression (TTP)(Up to approximately 6 years)
Number of Participants with Treatment-emergent Adverse Events (TEAEs)(Up to approximately 6 years)
Serum Concentration of Tarlatamab(Up to approximately 4 months)
Incidence of Anti-tarlatamab Antibody Formation(Up to approximately 1 year)
Complete Response (CR) Rate(Up to approximately 6 years)
CR + non-CR/non-Progressive Disease (PD) Rate(Up to approximately 6 years)
Duration of Complete Response(Up to approximately 6 years)
PFS Determined by Investigator Assessment(Up to approximately 6 years)
Objective Response (OR) Rate(Up to approximately 6 years)
Disease Control (DC) Rate(Up to approximately 6 years)
Duration of Response (DOR)(Up to approximately 6 years)
PFS at 6 months, 1 year, 2 years(6 months, 1 year, 2 years)
OS at 6 months, 1 year, 2 years, 3 years(6 months, 1 year, 2 years, 3 years)
Time to Progression (TTP)(Up to approximately 6 years)
Number of Participants with Treatment-emergent Adverse Events (TEAEs)(Up to approximately 6 years)
Serum Concentration of Tarlatamab(Up to approximately 4 months)
Incidence of Anti-tarlatamab Antibody Formation(Up to approximately 1 year)