Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 970
- 试验地点
- 225
- 主要终点
- Overall Survival (OS) in current smokers
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Life expectancy > 12 weeks
- •Subject must have cytologically or histologically confirmed squamous NSCLC.
- •Subject must have advanced or metastatic squamous NSCLC that is not amenable to surgical resection or radiation with curative intent at time of study Screening.
- •Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable to surgical resection or radiation with curative intent are eligible.
- •Subject must have at least 1 unidimensional measurable NSCLC lesion on a computerized tomography (CT) scan as defined by Response Evaluation Criteria In Solid Tumors (RECIST - version 1.1).
排除标准
- •Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
- •Subject has a known hypersensitivity to platinum compounds.
- •Subject has peripheral neuropathy >= grade
- •Subject has non-squamous NSCLC, or a known epidermal growth factor receptor (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21, or a known anaplastic lymphoma kinase (ALK) gene rearrangement.
- •Subject has received prior cytotoxic chemotherapy (including definitive chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.
研究组 & 干预措施
Veliparib + Carboplatin + Paclitaxel
Participants received veliparib 120 mg orally twice daily (BID) on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an area under the concentration-time curve (AUC) 6 mg/mL/min and paclitaxel 200 mg/m² by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression.
干预措施: Carboplatin (Drug)
Veliparib + Carboplatin + Paclitaxel
Participants received veliparib 120 mg orally twice daily (BID) on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an area under the concentration-time curve (AUC) 6 mg/mL/min and paclitaxel 200 mg/m² by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression.
干预措施: Veliparib (Drug)
Veliparib + Carboplatin + Paclitaxel
Participants received veliparib 120 mg orally twice daily (BID) on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an area under the concentration-time curve (AUC) 6 mg/mL/min and paclitaxel 200 mg/m² by intravenous (IV) infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression.
干预措施: Paclitaxel (Drug)
Placebo + Carboplatin + Paclitaxel
Participants received placebo orally BID on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an AUC 6 mg/mL/min and paclitaxel 200 mg/m² by IV infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression.
干预措施: Carboplatin (Drug)
Placebo + Carboplatin + Paclitaxel
Participants received placebo orally BID on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an AUC 6 mg/mL/min and paclitaxel 200 mg/m² by IV infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression.
干预措施: Paclitaxel (Drug)
Placebo + Carboplatin + Paclitaxel
Participants received placebo orally BID on Days -2 to 5 (7 consecutive days) of each 21-day cycle and carboplatin at an AUC 6 mg/mL/min and paclitaxel 200 mg/m² by IV infusion on Day 1 of each 21-day cycle for up to a maximum 6 cycles of treatment, until treatment toxicity which, in the Investigator's opinion, prohibited further therapy, or until radiographic progression.
干预措施: Placebo to veliparib (Drug)
结局指标
主要结局
Overall Survival (OS) in current smokers
时间窗: Up to 3 years from first dose of study drug
Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.
次要结局
- Progressive-Free Survival (PFS) in current smokers and in all subjects(Up to 3 years from first dose of study drug)
- Objective Response Rate (ORR) in current smokers and in all subjects(Up to 3 years from first dose of study drug)
- Overall Survival (OS) in all subjects(Up to 3 years from first dose of study drug)