A Randomized Phase 2 Study of Abemaciclib (LY2835219) Versus Docetaxel in Patients With Stage IV Squamous Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 9
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The main purpose of this study is to evaluate the effectiveness of the study drug known as abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy.
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
- •Confirmed diagnosis of stage IV NSCLC.
- •Have progressed during or after platinum-based chemotherapy for advanced disease.
- •Have not received prior treatment with docetaxel.
- •Have availability of adequate formalin-fixed paraffin-embedded (FFPE) tumor derived material.
- •Have adequate organ function including hematology, renal, and liver.
- •Have good performance score (0-1).
- •Have measurable disease per RECIST 1.
- •Agree to use a reliable medically approved method of birth control.
排除标准
- •Have received prior treatment with any cyclin dependent kinase (CDK) 4 and 6 inhibitor or participated in a clinical trial with a CDK 4 and 6 inhibitor and the treatment administered is not known.
- •Are currently receiving treatment in a clinical trial involving an investigational product or non-approved use of a drug or device.
- •Have the presence of unstable central nervous system (CNS) metastasis.
- •Have had major surgery (excluding biopsy) < 28 days of the initial dose of study drug.
研究组 & 干预措施
Abemaciclib
200 milligram (mg) abemaciclib given orally every 12 hours (Q12H) on days 1 to 21 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
干预措施: Abemaciclib (Drug)
Docetaxel
75 milligram per meter squared (mg/m²) docetaxel given intravenously (IV) on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Baseline to Objective Progression or Death from Any Cause ( Up To 6 Months)
PFS was defined as time from the date of randomization to the date of investigator-determined disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, with reference the smallest sum on study and an absolute increase of at least 5mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant was not known to have died or have objective progression, PFS time will be censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available.
次要结局
- Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR): Disease Control Rate (DCR)(Baseline through Measured Progressive Disease or Death Due to Any Cause (Up To 6 Months))
- Pharmacokinetics (PK): Clearance of Abemaciclib(Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose)
- PK: Volume of Distribution of Abemaciclib(Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose)
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])(Baseline to Objective Progression (Up To 6 Months))
- Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores(Baseline through End of Study (Up To 6 Months))
- Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire Index Value(Baseline to Measured Progressive Disease (Up To 6 Months))
- Overall Survival (OS)(Baseline to Date of Death from Any Cause (Up To 28 Months))
- Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status of >/=2(Randomization to ECOG PFS of >/=2 (Up To 11.5 Months))
- Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire EQ VAS Overall Self-rated Health Score(Baseline to Measured Progressive Disease (Up To 6 Months))