2025-523819-11-00招募中3 期
A Phase 3 Randomized, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of ABBV-706 versus Standard of Care in Subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 78
- 主要终点
- Objective Response (OR) as Measured by Overall Response Rate (ORR) Based on Blinded Independent Central Review (BICR)
研究概览
简要总结
• To demonstrate the superiority of ABBV-706 versus standard of care comparator (topotecan, lurbinectedin, or amrubicin) in terms of objective response (OR) as measured by ORR based on blinded independent central review (BICR) assessment per RECIST v1.1. • To demonstrate the superiority of ABBV-706 versus standard of care comparator (topotecan, lurbinectedin, or amrubicin) in terms of efficacy as measured by overall survival (OS).
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
- 否
入选标准
- •Diagnosis of histologically or cytologically confirmed Relapsed/Refractory (R/R) Small Cell Lung Cancer (SCLC).
- •Participants must be considered suitable to receive Standard of care (SOC) comparator (topotecan, lurbinectedin, or amrubicin).
- •Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 during the screening period prior to the first dose of study treatment.
- •Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.
- •Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •Participants must have progressed on prior systemic therapy, with CPI (if eligible) and prior tarlatamab, defined as: - In the 1L and 2L setting respectively, platinum-based chemotherapy (i.e., carboplatin or cisplatin and etoposide with CPI, if eligible for CPI) and 2L tarlatamab; or - In the 1L and 2L setting, platinum-based chemotherapy (i.e., carboplatin and etoposide with atezolizumab and lurbinectedin in combination with atezolizumab maintenance and 2L tarlatamab; or - In the 1L setting, platinum-based chemotherapy (i.e., carboplatin or cisplatin and etoposide with CPI if eligible) in combination with tarlatamab in frontline induction and/or maintenance
- •Participants with brain metastasis from an extracranial solid tumor are eligible if the brain metastases are: - Previously treated and not requiring anticonvulsants and steroids for at least 7 days prior to first dose of study treatment. If required for management, subjects on a steroid equivalent of prednisone dose of ≤ 10 mg/day are eligible or; - Untreated and asymptomatic not requiring anticonvulsants and steroids for at least 7 days prior to the first dose of study treatment. If required for management, subjects on a steroid equivalent of prednisone of ≤ 10 mg/day are eligible.
排除标准
- •Participants with known active/symptomatic central nervous system metastases
- •Participants with a history of interstitial lung disease (ILD) or pneumonitis that previously required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT)-scan.
- •Participants with any clinically significant conditions that would adversely affect the subject's participation in the study, and the subject should have a life expectancy of at least 3 months.
- •Participants who have received prior treatment with a seizure-related 6 homolog (SEZ6) targeted Antibody drug conjugate (ADC), other targeted ADCs, or any other investigational agent not including tarlatamab in 1L.
- •Participants who have received prior treatment with any Top1i such as topotecan, irinotecan, belotecan, camptothecin, rubitecan, exatecan or locally approved topoisomerase I inhibitor (Top1i) payload.
研究组 & 干预措施
ABBV-706
Test
干预措施: ABBV-706 (Drug)
TOPOTECAN, TOPOTECAN, TOPOTECAN
Comparator
干预措施: TOPOTECAN (Drug)
结局指标
主要结局
Objective Response (OR) as Measured by Overall Response Rate (ORR) Based on Blinded Independent Central Review (BICR)
Objective Response (OR) as Measured by Overall Response Rate (ORR) Based on Blinded Independent Central Review (BICR)
Overall Survival (OS)
Overall Survival (OS)
次要结局
- Progression-free survival (PFS) based on BICR assessment per RECIST v1.1.
- Duration of response (DoR) based on BICR assessment per RECIST v1.1.
- Change from baseline at Week 12 in physical functioning as measured by the physicalfunctioning domain of the EORTC QLQ-C30.
- Change from baseline at Week 12 in Global Health Status (GHS)/Quality of life (QoL) as measured by the EORTC QLQ-C30 GHS/QoL scale
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (78)
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