2024-517490-24-00招募中2 期
SEZanne: A Phase 2 Randomized, Open label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 in Combination with Atezolizumab versus Standard of Care as First-Line Treatment in Subjects with Previously Untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 27
- 主要终点
- Progression-Free Survival (PFS) based on investigator assessment per RECIST v1.1.
研究概览
简要总结
- To evaluate the safety and tolerability of ABBV-706 in combination with atezolizumab
- To optimize and select the recommended Phase 3 dose (RP3D) of ABBV-706 in combination with atezolizumab
- To evaluate efficacy as measured by progression-free survival (PFS) of ABBV-706 in combination with atezolizumab
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
- •Diagnosis of histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC) requiring treatment with first line therapy.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 during the screening period prior to the first dose of study treatment.
- •Participants must be considered suitable to receive a platinum-based chemotherapy or atezolizumab regimen as first line treatment for ES-SCLC. Chemotherapy must contain carboplatin in combination with etoposide.
- •Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
排除标准
- •Histologically or cytologically confirmed mixed small cell lung cancer (SCLC).
- •Prior treatment of any kind for LS-SCLC.
- •Prior systemic therapy for the treatment of first line ES-SCLC.
- •Participants with known active/symptomatic central nervous system (CNS) metastases
- •Participants with a history of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest CT scan
研究组 & 干预措施
ATEZOLIZUMAB
Comparator
干预措施: ATEZOLIZUMAB (Drug)
CARBOPLATIN, CARBOPLATIN
Comparator
干预措施: CARBOPLATIN (Drug)
ABBV-706
Test
干预措施: ABBV-706 (Drug)
ETOPOSIDE
Comparator
干预措施: ETOPOSIDE (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) based on investigator assessment per RECIST v1.1.
Progression-Free Survival (PFS) based on investigator assessment per RECIST v1.1.
次要结局
- Overall Response (OR) as Measured by Overall Response Rate (ORR) based on investigator assessment per RECIST v1.1.
- Duration of Response (DoR) based on investigator assessment per RECIST v1.1.
- Disease Control (DC) based on investigator assessment per RECIST v1.1.
- OS
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (27)
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