NCT07778316招募中3 期
A Phase 3, Open-Label, Multicenter, Randomized Study of Subcutaneous vs Intravenous Tarlatamab in Participants With Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-315)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 400
- 试验地点
- 9
- 主要终点
- Area Under the Curve From Cycle 2 Day 1 to Day 15 (AUC C2D1-D15) of Tarlatamab
研究概览
简要总结
The primary objective of this study is to demonstrate non-inferiority in pharmacokinetic (PK) parameters of subcutaneous (SC) vs intravenous (IV) tarlatamab administration and to characterize the efficacy, safety, and tolerability of SC tarlatamab in participants with relapsed extensive-stage small-cell lung cancer (ES-SCLC) after platinum-based chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
- •History of central nervous system (CNS) metastases are allowed with considerations defined in the protocol.
排除标准
- •Disease Related
- •- Any previous diagnosis of non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation that has transformed to SCLC, or mixed SCLC and NSCLC histology, with exceptions defined in the protocol.
- •Other Medical Conditions
- •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 (e.g., stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
- •Current evidence or history of non-infectious pneumonitis/ILD (interstitial lung disease) that required steroids or other immunosuppressive treatment.
- •History of other malignancy within the past 2 years, with exceptions defined in the protocol.
- •Presence or history of viral infection based on criteria per protocol.
- •History of solid organ transplantation.
- •Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
- •Known sensitivity or a contraindication to any of the products or components.
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- •Prior/Concomitant Therapy
- •Prior systemic anticancer therapy within 30 days of enrolment
- •Prior history of severe or life-threatening events from any immune-mediated therapy.
- •Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment.
- •Live and live-attenuated vaccines within 28 days prior to the start of study treatment.
- •Receiving another anticancer therapy for a malignancy other than SCLC.
- •More than 1 prior line of anticancer therapy for SCLC.
- •Participation in a tarlatamab clinical trial or prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
- •Treatment in an alternative investigational trial within 28 days prior to enrolment.
- •History of allergy or hypersensitivity to similar products (eg, drugs with a similar chemical structure or other monoclonal antibody) or any excipient.
- •Other Exclusions
- •Participants unable to have SC injections administered in the abdomen or thigh.
- •Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements.
- •History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.
研究组 & 干预措施
Tarlatamab IV
Active Comparator
Participants will receive Tarlatamab via IV infusion
干预措施: Tarlatamab (Drug)
Tarlatamab SC
Experimental
Participants will receive Tarlatamab via SC injection
干预措施: Tarlatamab (Drug)
结局指标
主要结局
Area Under the Curve From Cycle 2 Day 1 to Day 15 (AUC C2D1-D15) of Tarlatamab
时间窗: From Cycle 2 Day 1 to Day 15 (each cycle is 28 days)
Predose Concentration (Ctrough) of Tarlatamab
时间窗: On Cycle 2 Day 15 (each cycle is 28 days)
次要结局
- Objective response (OR) per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)(Up to approximately 4 years)
- Progression free survival (PFS) per RECIST v1.1(Up to approximately 4 years)
- Duration of response (DOR) per RECIST v1.1(Up to approximately 4 years)
- Disease control (DC) per RECIST v1.1(Up to approximately 4 years)
- Overall survival (OS)(Up to approximately 4 years)
- Number of participants with treatment-emergent adverse events (TEAEs) and Treatment-related Adverse Events (TRAEs)(Up to approximately 4 years)
- Change from Baseline in Visual Analogue Scale (VAS) score of the EuroQol5 Dimension (EQ-5D-5L)(Up to approximately 4 years)
- Responses to Patient-Reported Adverse Events Questionnaire (PRO-CTCAE)(Up to approximately 4 years)
- Responses to Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire on symptom bother(Up to approximately 4 years)
- Responses to Therapy Administration Satisfaction Questionnaire (TASQ)(Up to approximately 4 years)
- Number of Participants with Anti-tarlatamab Antibody Formation(Up to approximately 4 years)
研究者
研究点 (9)
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