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)
概览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- AbbVie
- 入组人数
- 180
- 试验地点
- 30
- 主要终点
- Number of Participants with Adverse Events (AE)s
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, dose, change in disease activity of ABBV-706 given with atezolizumab, compared to standard of care (SOC) treatment (etoposide, carboplatin, atezolizumab, and optional lurbinectedin).
ABBV-706 is an investigational drug being developed for the treatment of SCLC. There are multiple treatment arms in this study. Participants will either receive ABBV-706 given with atezolizumab, at 1 of 2 doses, or SOC. Approximately 180 adult participants will be enrolled in the study across sites worldwide.
In the safety lead-in, participants with SCLC will receive intravenous (IV) ABBV-706 in 1 of 2 doses with IV atezolizumab, or IV SOC. In the expansion portion of the study, participants with SCLC will receive IV ABBV-706 in 1 of 2 doses with atezolizumab, or IV SOC, until the optimal dose of ABBV-706 is determined. The estimated duration of the study is up to 69.5 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
- Sequential
- 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 extensive stage small cell lung cancer (ES-SCLC) requiring treatment with first line therapy.
- •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.
- •Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- •Suspected brain metastases at screening should have a computed tomography (CT)/ magnetic resonance imaging (MRI) of the brain prior to study entry.
排除标准
- •Have received any kind of treatment for limited stage small cell lung cancer (LS-SCLC).
- •Known active/symptomatic central nervous system (CNS) metastases should be excluded.
- •History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan should be excluded.
- •Have any clinically significant conditions that would adversely affect the participant's participation in the study, and the subject should have a life expectancy of at least 3 months.
研究组 & 干预措施
Safety Lead-In: Stand of Care (SOC)
Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration.
干预措施: Lurbinectedin (Drug)
Expansion: ABBV-706 Dose A
Participants will receive ABBV-706 dose A in combination with atezolizumab, as part of the approximately 69.5 month study duration.
干预措施: ABBV-706 (Drug)
Expansion: ABBV-706 Dose A
Participants will receive ABBV-706 dose A in combination with atezolizumab, as part of the approximately 69.5 month study duration.
干预措施: Atezolizumab (Drug)
Safety Lead-In: ABBV-706 Dose A
Participants will receive ABBV-706 dose A in combination with atezolizumab, as part of the approximately 69.5 month study duration.
干预措施: Atezolizumab (Drug)
Safety Lead-In: ABBV-706 Dose A
Participants will receive ABBV-706 dose A in combination with atezolizumab, as part of the approximately 69.5 month study duration.
干预措施: ABBV-706 (Drug)
Expansion: SOC
Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration.
干预措施: Carboplatin (Drug)
Expansion: ABBV-706 Dose B
Participants will receive ABBV-706 dose B in combination with atezolizumab, as part of the approximately 69.5 month study duration.
干预措施: Atezolizumab (Drug)
Expansion: SOC
Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration.
干预措施: Etoposide (Drug)
Expansion: ABBV-706 Dose B
Participants will receive ABBV-706 dose B in combination with atezolizumab, as part of the approximately 69.5 month study duration.
干预措施: ABBV-706 (Drug)
Expansion: SOC
Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration.
干预措施: Lurbinectedin (Drug)
Expansion: SOC
Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration.
干预措施: Atezolizumab (Drug)
Safety Lead-In: Stand of Care (SOC)
Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration.
干预措施: Etoposide (Drug)
Safety Lead-In: ABBV-706 Dose B
Participants will receive ABBV-706 dose B in combination with atezolizumab, as part of the approximately 69.5 month study duration.
干预措施: Atezolizumab (Drug)
Safety Lead-In: Stand of Care (SOC)
Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration.
干预措施: Atezolizumab (Drug)
Safety Lead-In: ABBV-706 Dose B
Participants will receive ABBV-706 dose B in combination with atezolizumab, as part of the approximately 69.5 month study duration.
干预措施: ABBV-706 (Drug)
Safety Lead-In: Stand of Care (SOC)
Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AE)s
时间窗: Up to 69.5 Months
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Number of Participants with Adverse Events (AE)s
时间窗: Up to 69.5 Months
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Progression-Free Survival (PFS) Based on Investigator Assessment
时间窗: Up to Approximately 24 Months
PFS is defined as the time from randomization to the first documentation of radiological progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator or death from any cause, whichever occurs first.
次要结局
- Overall Response (OR) as Measured by Overall Response Rate (ORR) Based on Investigator Assessment(Up to Approximately 24 Months)
- Duration of Response (DoR) Based on Investigator Assessment(Up to Approximately 24 Months)
- Disease Control (DC) Based on Investigator Assessment(Up to Approximately 24 Months)
- OS(Up to Approximately 28 Months)