2024-516051-40-00招募中2 期
A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects with Small Cell Lung Cancer (SCLC) (DeLLphi-309)
Amgen Inc.23 个研究点 分布在 6 个国家目标入组 60 人开始时间: 2025年5月5日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 23
- 主要终点
- Confirmed OR (CR + PR)
研究概览
简要总结
Evaluate the efficacy of tarlatamab on ORR based on blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Treatment Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Subject has provided informed consent before initiation of any study-specific activities/procedures. Exception: Standard of care imaging and laboratory assessments performed prior to informed consent.
- •Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
- •Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
- •Subject has progressed or recurred following 1 platinum-based regimen. In countries where standard of care first-line systemic treatment for ES disease includes platinum-containing chemotherapy in combination with PD-(L)1 inhibitor, it is required that subjects have failed PD-(L)-1 inhibitor as part of their first-line systemic treatment or are ineligible to receive PD-(L)1 inhibitor therapy.
- •Measurable disease at baseline per RECIST 1.1 within the 21-day screening period. - Screening scans performed as standard of care and prior to informed consent, may be used to confirm subject eligibility if completed within the 21-day screening period, provided that informed consent for the use of these scans is obtained prior to any transfer of data.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Minimum life expectancy of 12 weeks.
- •Adequate organ function, defined as follows: Refer to protocol section 5.1 for more details. - Hematological function: - Coagulation function: - Renal function: - Hepatic function: - Pulmonary function: -Cardiac function:
排除标准
- •Any previous diagnosis of transformed non-small cell lung cancer (NSCLC) including epidermal growth factor receptor activating mutation positive NSCLC that has transformed to SCLC
- •History of solid organ transplantation.
- •Prior anticancer therapy within 30 days of enrollment (14 days for conventional chemotherapy
- •Treatment with live virus, including live-attenuated vaccination, within 14 days prior to the first dose of study treatment. Inactive vaccines (eg, non-live or non-replicating agent) and live viral non-replicating vaccines (eg, Jynneos for Monkeypox infection) within 3 days prior to first dose of study treatment
- •Prior enrollment on a tarlatamab clinical trial OR prior therapy with any selective inhibitor of the DLL3 pathway.
- •Receiving other anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy. Subjects who are receiving adjuvant hormonal therapy for resected breast cancer may be eligible (refer also to exclusion related to history of other malignancies).
- •Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment (see protocol section 5.2 for exceptions)
- •Female subjects of childbearing potential with a positive pregnancy test assessed at screening and/or day 1 by a highly sensitive urine or serum pregnancy test
- •Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment & for an additional XX days after the last dose of tarlatamab
- •Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional XX days after the last dose of tarlatamab
- •Male subjects unwilling to abstain from donating sperm during treatment & for an additional XX days after the last dose of tarlatamab
- •History of other malignancy within the past 2 years (see protocol section 5.2 for exceptions)
- •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
- •Prior history of severe or life-threatening events from any immune-mediated therapy
- •Major surgical procedures within 21 days prior to first dose of study treatment
- •Presence or history of viral infection: Human immunodeficiency virus (HIV) infection, Active hepatitis B or C infection
- •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
- •Symptomatic central nervous system (CNS) metastases (see protocol section 5.2 for exceptions)
- •Subject has known sensitivity to any of the products or components to be administered during dosing
- •Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment on another investigational device or drug study(ies). Other investigational procedures and participation in observational research studies while participating in this study are excluded
- •Evidence of interstitial lung disease or active, non-infectious pneumonitis.
- •Female subjects of childbearing potential unwilling to use protocol-specified method of contraception during treatment & for an additional XX days after the last dose of tarlatamab
- •Female subjects who are breastfeeding or who plan to breastfeed while on study through XX days after the last dose of tarlatamab.
- •Female subjects planning to become pregnant or donate eggs while on study through XX days after the last dose of tarlatamab.
- •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
结局指标
主要结局
Confirmed OR (CR + PR)
Confirmed OR (CR + PR)
CR (Complete Response)
CR (Complete Response)
PR (Partial Response)
PR (Partial Response)
次要结局
- DOR - Duration of confirmed response
- serum concentrations of tarlatamab
- DC -Disease control is defined as objective response or stable disease.
- Duration of DC
- PFS-Progression-free survival
- OR - Objective response is defined as best overall response of CR or PR.
- Overall survival (OS) -Overall survival is defined as the time from randomization to death due to any cause.
- OS rate at 6 months and 1 year from randomization
- Incidence of treatment-emergent adverse events
- Incidence of anti-tarlatamab antibody formation
研究者
Medical Information
Scientific
Amgen Inc.
研究点 (23)
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