临床试验/NCT05361395

NCT05361395

进行中（未招募）

1 期

A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung (DeLLphi-303)

Amgen76 个研究点分布在 14 个国家目标入组 184 人2022年8月24日

适应症Extensive Stage Small Cell Lung Cancer

干预措施Tarlatamab Carboplatin Etoposide Atezolizumab Durvalumab

概览

阶段: 1 期
干预措施: Tarlatamab
疾病 / 适应症: Extensive Stage Small Cell Lung Cancer
发起方: Amgen
入组人数: 184
试验地点: 76
主要终点: Number of Participants with Clinically Significant Changes in Vital Signs
状态: 进行中（未招募）
最后更新: 2个月前

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

概览

简要总结

This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.

注册库

clinicaltrials.gov

开始日期

2022年8月24日

结束日期

2028年8月28日

最后更新

2个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

责任方

Sponsor

入排标准

入选标准

•Participant has provided informed consent prior to initiation of any study specific activities/procedures.
•Age greater than or equal to 18 years old at the same time of signing the informed consent.
•Histologically or cytologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC.
•Participants with prior treatment for limited-stage SCLC (LS-SCLC) are permitted.
•Eastern Cooperative Oncology Group (ECOG) 0 to
•Participants with treated asymptomatic brain metastases are eligible provided they meet defined criteria.
•Adequate organ function as defined in protocol.

排除标准

•History of other malignancy within the past 2 years with exceptions.
•Major surgery within 28 days of study day
•Untreated or symptomatic brain metastases and leptomeningeal disease.
•Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
•History of immune-related colitis.
•History or evidence of interstitial lung disease or active, non-infectious pneumonitis.
•Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
•Participants 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
•Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint
•NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to an active treatment and after consultation with Medical Monitor. Participants requiring oral antibiotics who have been afebrile for \>24 hours, have no leukocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required.

研究组 & 干预措施

Part 1: Dose Exploration Combination Regimen 1

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

干预措施: Tarlatamab

Part 1: Dose Exploration Combination Regimen 1

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

干预措施: Carboplatin

Part 1: Dose Exploration Combination Regimen 1

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

干预措施: Etoposide

Part 1: Dose Exploration Combination Regimen 1

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

干预措施: Atezolizumab

Part 2: Dose Exploration Combination Regimen 2

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

干预措施: Tarlatamab

Part 2: Dose Exploration Combination Regimen 2

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

干预措施: Carboplatin

Part 2: Dose Exploration Combination Regimen 2

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

干预措施: Etoposide

Part 2: Dose Exploration Combination Regimen 2

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

干预措施: Atezolizumab

Part 3: Dose Exploration Combination Regimen 3

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

干预措施: Atezolizumab

Part 3: Dose Exploration Combination Regimen 3

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

干预措施: Tarlatamab

Part 3: Dose Exploration Combination Regimen 3

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

干预措施: Carboplatin

Part 3: Dose Exploration Combination Regimen 3

Tarlatamab+Atezolizumab+Carboplatin+Etoposide

干预措施: Etoposide

Part 4: Dose Expansion

Expansion of Part 1, Part 2, or Part 3 with Atezolizumab

干预措施: Carboplatin

Part 4: Dose Expansion

Expansion of Part 1, Part 2, or Part 3 with Atezolizumab

干预措施: Tarlatamab

Part 4: Dose Expansion

Expansion of Part 1, Part 2, or Part 3 with Atezolizumab

干预措施: Etoposide

Part 4: Dose Expansion

Expansion of Part 1, Part 2, or Part 3 with Atezolizumab

干预措施: Atezolizumab

Part 5: Dose Exploration Maintenance

Tarlatamab+Atezolizumab

干预措施: Tarlatamab

Part 5: Dose Exploration Maintenance

Tarlatamab+Atezolizumab

干预措施: Atezolizumab

Part 7: Dose Expansion

Expansion of Part 1, 2, or 3 with Durvalumab

干预措施: Carboplatin

Part 6: Dose Expansion Maintenance

Expansion of Part 5 with Atezolizumab

干预措施: Tarlatamab

Part 6: Dose Expansion Maintenance

Expansion of Part 5 with Atezolizumab

干预措施: Atezolizumab

Part 7: Dose Expansion

Expansion of Part 1, 2, or 3 with Durvalumab

干预措施: Tarlatamab

Part 7: Dose Expansion

Expansion of Part 1, 2, or 3 with Durvalumab

干预措施: Etoposide

Part 7: Dose Expansion

Expansion of Part 1, 2, or 3 with Durvalumab

干预措施: Durvalumab

Part 8: Dose Expansion Maintenance

Expansion of Part 5 with Durvalumab

干预措施: Tarlatamab

Part 8: Dose Expansion Maintenance

Expansion of Part 5 with Durvalumab

干预措施: Durvalumab

Part 9: Dose Expansion Maintenance

Expansion with Tarlatamab+Durvalumab

干预措施: Tarlatamab

Part 9: Dose Expansion Maintenance

Expansion with Tarlatamab+Durvalumab

干预措施: Durvalumab

结局指标

主要结局

Number of Participants with Clinically Significant Changes in Vital Signs

时间窗: 24 months

Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements

时间窗: 24 months

Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests

时间窗: 24 months

Number of Participants with a Dose Limiting Toxicity (DLT)

时间窗: 24 months

Number of Participants with Treatment-emergent Adverse Events (TEAE)

时间窗: 24 months

Number of Participants with Treatment-related Adverse Events

时间窗: 24 months

次要结局

6-month Progression-free Survival (PFS)(24 months)
Objective Response (OR)(24 months)
Duration of Response (DOR)(24 months)
Disease Control Rate(DCR)(24 months)
Overall Survival (OS)(24 months)
Serum Concentration of Tarlatamab(24 months)

研究点 (76)

Loading locations...

相似试验

A Study of AMG 757 in Participants With Neuroendocrine Prostate CancerNeuroendocrine Prostate Cancer

NCT04702737Amgen41

Study of How Safe and Effective Tarlatamab is in Brain Cancers

NCT06776250University Health Network, Toronto44

进行中（未招募）

A Phase I/II Study of TJ004309 for Advanced Solid TumorAdvanced Solid Tumor

NCT04322006TJ Biopharma Co., Ltd.376

进行中（未招募）

Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment

NCT06502977Amgen32

TITAN (Tumoural Injection of T-VEC and Isolated Limb Perfusion)Melanoma and Sarcoma

NCT03555032Royal Marsden NHS Foundation Trust15