2023-506235-15-00招募中3 期
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 (DeLLphi-306)
Amgen Inc.75 个研究点 分布在 9 个国家目标入组 145 人开始时间: 2024年11月18日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 145
- 试验地点
- 75
- 主要终点
- PFS (BICR)
研究概览
简要总结
Compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS) based on blinded independent central review (BICR) per RECIST 1.1
Compare the efficacy of tarlatamab with placebo on prolonging overall survival (OS)
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double (Carer, Analyst, Monitor, Subject, Investigator)
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
- •Subject 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 SCLC.
- •Diagnosed and treated for LS-SCLC with concurrent chemotherapy and radiotherapy
- •Has completed chemoradiotherapy without progression per RECIST 1.
- •(ie, achieved CR, PR, or 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
- •Extensive-stage SCLC
- •Female subjects of childbearing potential unwilling to use protocol specified method of contraception see protocol Appendix 5 (Section 11.5) during treatment and for an additional 60 days after the last dose of study treatment.
- •Female subjects who are breastfeeding or to become pregnant who plan to breastfeed or while on study through 60 days after the last dose of study treatment.
- •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.
- •Female subjects planning to become pregnant or donate eggs while on study through 60 days after the last dose of study treatment.
- •Male subjects with a female partner of childbearing potential or a pregnant partner who are unwilling to practice sexual abstinence or use contraception during treatment and for an additional 60 days after the last dose of study treatment
- •Male subjects unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of study treatment.
- •Subject has known sensitivity to any of the products or components to be administered during dosing.
- •Subject likely to not be available to complete all protocol-required study visits or procedures
- •History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- •Evidence of interstitial lung disease or active, non-infectious pneumonitis.
- •Received sequential chemotherapy and thoracic radiotherapy during chemoradiation.
- •History of other malignancy within the past 2 years. Refer to protocol section 5.2 for more details.
- •History of solid organ transplantation.
- •Myocardial infarction and/or symptomatic congestive heart failure within 6 months prior to first dose of study treatment.
- •History of arterial thrombosis within 6 months prior to first dose of study treatment.
- •Presence of active Human immunodeficiency virus (HIV) or active hepatitis infection. Refer to protocol section 8.4.5.5 for more details.
- •Subject with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment.
- •Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of study treatment
- •Prior therapy with any selective inhibitor of the DLL3 pathway.
- •Prior history of severe or life-threatening events from any immunemediated therapy.
- •Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.
- •Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment
- •Major surgical procedures within 28 days prior to first dose of study treatment.
- •Treatment with live virus, including live-attenuated vaccination, within 14 days prior to the first dose of study treatment. Inactive vaccines and live viral non-replicating vaccines within 3 days prior to first dose of study treatment.
- •Treatment in an alternative investigational trial within 28 days prior to enrollment.
研究组 & 干预措施
ELECTROLYTES
Auxiliary
干预措施: ELECTROLYTES (Drug)
VASOPRESSIN (ARGIPRESSIN)
Auxiliary
干预措施: VASOPRESSIN (ARGIPRESSIN) (Drug)
PARACETAMOL
Auxiliary
干预措施: PARACETAMOL (Drug)
PREDNISOLONE
Auxiliary
干预措施: PREDNISOLONE (Drug)
SILTUXIMAB
Auxiliary
干预措施: SILTUXIMAB (Drug)
TOCILIZUMAB
Auxiliary
干预措施: TOCILIZUMAB (Drug)
Placebo for Tarlatamab (AMG-757)
Placebo
干预措施: Placebo for Tarlatamab (AMG-757) (Drug)
Tarlatamab, Tarlatamab
Test
干预措施: Tarlatamab (Drug)
DEXAMETHASONE
Auxiliary
干预措施: DEXAMETHASONE (Drug)
结局指标
主要结局
PFS (BICR)
PFS (BICR)
OS
OS
次要结局
- Complete response (CR) based on BICR and investigator assessment per RECIST 1.1. XX based on BICR and investigator assessment per RECIST 1.1. Duration of complete response.
- Incidence of treatment-emergent adverse events after randomization
- Serum concentration of tarlatamab
- Incidence of anti-tarlatamab antibody formation
- PFS (investigator)
- OR, DC and DOR
- "PFS and OS rate at 6 months, 1 and 2 years from randomization. OS rate at 6 months, 1 year, 2 years and 3 years from randomization. TTP "
研究者
Medical Information
Scientific
Amgen Inc.
研究点 (75)
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