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)
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- AbbVie
- 入组人数
- 531
- 主要终点
- Objective Response (OR) as Measured by Overall Response Rate (ORR) Based on Blinded Independent Central Review (BICR)
概览
简要总结
Small cell lung cancer (SCLC) is characterized by aggressive and rapid growth and a tendency to develop early spread to distant sites including mediastinal lymph nodes, liver, bones, adrenal glands, and brain. The purpose of this study is to assess safety, tolerability, and change in disease activity of ABBV-706 compared to standard of care (SOC) treatment (topotecan, lurbinectedin, or amrubicin).
ABBV-706 is an investigational drug being developed for the treatment of SCLC. There are two treatment arms in this study. Participants will either receive ABBV-706 or SOC. Approximately 531 adult participants will be enrolled in the study across 175 sites worldwide.
Participants with SCLC will receive intravenous (IV) ABBV-706 or SOC [topotecan (IV or orally), or lubinectedin (IV), or amrubicin (IV)]. The estimated duration of the study is approximately 53 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
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 —（Adult, Older Adult）
- 性别
- All
- 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 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 must be considered suitable to receive 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 with brain metastasis from an extracranial solid tumor are eligible if the brain metastases are:
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 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
Participants will receive ABBV-706 as part of the 53 month study duration.
干预措施: ABBV-706 (Drug)
Stand of Care (SOC)
Participants will receive SOC (topotecan, lurbinectedin, and amrubicin) as part of the 53 month study duration.
干预措施: Topotecan (Drug)
Stand of Care (SOC)
Participants will receive SOC (topotecan, lurbinectedin, and amrubicin) as part of the 53 month study duration.
干预措施: Lurbinectedin (Drug)
Stand of Care (SOC)
Participants will receive SOC (topotecan, lurbinectedin, and amrubicin) as part of the 53 month study duration.
干预措施: Amrubicin (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)
时间窗: Up to approximately 24 months
OR is defined as participants achieving a best overall response (BOR) of confirmed complete response (CR)/partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by BICR assessment prior to initiation of subsequent anti-cancer therapy. OR will be summarized by ORR, defined as the percentage of participants achieving OR and will be summarized for each arm with its associated 95% confidence interval (CI).
Overall Survival (OS)
时间窗: Up to approximately 28 months
OS is defined as the time from the date of randomization to the date of death of any cause.
次要结局
- Progression-free survival (PFS) based on BICR assessment per RECIST v1.1.(Up to Approximately 24 Months)
- Duration of response (DoR) based on BICR assessment per RECIST v1.1.(Up to Approximately 24 Months)
- Change from baseline at Week 12 in physical functioning as measured by the physical functioning domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).(Week 12)
- 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(Week 12)
- Number of Participants with Adverse Events (AEs)(Up to Approximately 53 Months)