2023-505989-29-00招募中3 期
A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination with Durvalumab vs Durvalumab Alone in Subjects with Extensive Stage Small Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi 305)
Amgen Inc.74 个研究点 分布在 12 个国家目标入组 318 人开始时间: 2024年12月13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
- 318
- 试验地点
- 74
- 主要终点
- OS
研究概览
简要总结
To compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS)
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 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
- •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).
- •Completed 4 cycles of platinum-etoposide chemotherapy with concurrent durvalumab as first-line treatment of ES-SCLC prior to enrollment, without disease progression (ongoing response or stable disease) per RECIST 1.
- •· Patients with 3 cycles of concurrent durvalumab are eligible, provided 4 cycles of platinum-etoposide chemotherapy are completed.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or
- •Minimum life expectancy > 12 weeks.
- •Toxicities attributed to concurrent chemoradiotherapy resolved to grade ≤ 1, unless otherwise specified. Excluding alopecia or fatigue.
- •Adequate organ function, defined as follows: Refer to protocol section 5.1 for more details.
排除标准
- •Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.
- •History of solid organ transplantation.
- •Myocardial infarction and/or symptomatic congestive heart failure within 6 months prior to first dose of study treatment.
- •Major surgical procedures prior to first dose of study treatment.
- •History of arterial thrombosis within 6 months prior to first dose of study treatment.
- •Prior therapy with any selective inhibitor of the DLL3 pathway.
- •Receiving another anticancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.
- •Male subjects unwilling to abstain from donating sperm during treatment
- •Female subjects who are breastfeeding or who plan to breastfeed while on study
- •Female subjects of childbearing potential unwilling to use protocol specified method of contraception during treatment see Appendix 5 (Section 11.5)
- •Presence of active HIV or hepatitis infection
- •Evidence of ILD or active, non infectious pneumonitis.
- •Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test.
- •Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence or use contraception during treatment. see Appendix 5 (Section 11.5)
- •History of allergic reactions or acute hypersensitivity reactions to antibody therapies, platinum chemotherapy, or etoposide.
- •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
- •Live and live-attenuated vaccines within 4 weeks prior to the first dose of study treatment. Inactive vaccinesand live viral non-replicating vaccines within 30 days prior to first dose of study treatment.
- •Female subjects planning to become pregnant or donate eggs while on study
- •History or evidence of any other clinically significant disorder, condition or disease
- •Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment.
- •Has received or is planning to receive consolidative chest radiation, for extensive stage disease. • Prophylactic cranial irradiation is permitted, but must be completed prior to enrollment.
- •Prior history of severe or life-threatening events from any immune‑mediated therapy.
- •Treatment in an alternative investigational trial prior to enrollment.
- •Subject has known sensitivity to any of the products or components to be administered during dosing.
- •History of other malignancy within the past 2 years
- •Active or prior documented autoimmune or inflammatory disorders
研究组 & 干预措施
CARBOPLATIN
Auxiliary
干预措施: CARBOPLATIN (Drug)
VASOPRESSIN (ARGIPRESSIN)
Auxiliary
干预措施: VASOPRESSIN (ARGIPRESSIN) (Drug)
ELECTROLYTES
Auxiliary
干预措施: ELECTROLYTES (Drug)
DURVALUMAB
Test
干预措施: DURVALUMAB (Drug)
Tarlatamab, Tarlatamab
Test
干预措施: Tarlatamab (Drug)
CISPLATIN
Auxiliary
干预措施: CISPLATIN (Drug)
SILTUXIMAB
Auxiliary
干预措施: SILTUXIMAB (Drug)
MYCOPHENOLATE MOFETIL
Auxiliary
干预措施: MYCOPHENOLATE MOFETIL (Drug)
PREDNISOLONE
Auxiliary
干预措施: PREDNISOLONE (Drug)
PARACETAMOL
Auxiliary
干预措施: PARACETAMOL (Drug)
DEXAMETHASONE
Auxiliary
干预措施: DEXAMETHASONE (Drug)
INFLIXIMAB
Auxiliary
干预措施: INFLIXIMAB (Drug)
ETOPOSIDE
Auxiliary
干预措施: ETOPOSIDE (Drug)
TOCILIZUMAB
Auxiliary
干预措施: TOCILIZUMAB (Drug)
结局指标
主要结局
OS
OS
次要结局
- PFS
- Incidence of treatment emergent adverse events after randomization
- PFS rate at 6 months 1 year and 2 years from randomization OS rate at 6 months 1 year 2 years, and 3 years from randomization TTP
- Serum concentrations of tarlatamab
- Change from baseline up to week 13 and week 25 in disease symptoms of Cough Chest Pain and Dyspnea "
- Incidence of anti-tarlatamab antibody formation
- OR, DC, DoR.
- Time to first deterioration (TTD) for Physical function Global health status/Quality of life
研究者
Medical Information
Scientific
Amgen Inc.
研究点 (74)
Loading locations...
相似试验
招募中
3 期
A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence2023-507689-26-00Astrazeneca AB94
招募中
3 期
A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC 8)2023-506891-28-00Astrazeneca AB280
招募中
3 期
Study of durvalumab or placebo administered with radiation therapy for patients with early stage non-small cell lung cancer
Study of osimertinib administered after radiation therapy in patients with early stage non-small cell lung cancer harboring an EGFR mutation2024-512667-31-00AstraZeneca AB148
招募中
3 期
A Global Study to Assess the Effects of Durvalumab with Oleclumab or Durvalumab with Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC-9)2023-503999-24-00AstraZeneca AB437
招募中
3 期
A trial to learn how well durvalumab and chemotherapy with or without tremelimumab work in adults with advanced cancer of the bladder or urinary system2024-510976-19-00AstraZeneca AB353