A Randomized, Open-Label Phase 2 Study Evaluating LY2875358 Plus Erlotinib and LY2875358 Monotherapy in MET Diagnostic Positive NSCLC Patients With Acquired Resistance to Erlotinib
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 30
- 主要终点
- Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
研究概览
简要总结
The primary purpose of this study is to evaluate the efficacy of the study drug known as LY2875358, administered alone or in combination with a second drug named Erlotinib, in participants affected by a defined type of lung cancer (MET biomarker diagnostic positive Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent treatment with Erlotinib.
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 metastatic Stage IV NSCLC
- •At least 1 measurable extra-central nervous system (CNS) lesion
- •Documented radiographic progression while on continuous treatment with erlotinib monotherapy
- •Objective clinical benefit from erlotinib treatment as defined by either documented partial or complete response or stable disease ≥6 months or, if most recent erlotinib treatment has been initiated based on documented epidermal growth factor receptor mutation (EGFRmt) status, at least 12 weeks stable disease
- •Determined to be MET diagnostic positive (+)
- •Availability of a tumor sample post-erlotinib progression
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- •Have adequate organ function
排除标准
- •Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device
- •Have previously been treated with LY2875358 or any other MET-targeting experimental therapeutic
- •Have a serious concomitant systemic disorder or significant cardiac disease
- •Have interstitial pneumonia or interstitial fibrosis of the lung or have pleural effusion, pericardial fluids or ascites, requiring drainage every other week or more frequently
- •Have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study
- •Have major surgery less than 2 weeks prior initiation of study treatment therapy
- •Pregnant or lactating women
- •Have symptomatic CNS metastasis
研究组 & 干预措施
Arm A: Emibetuzumab plus Erlotinib
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
干预措施: Erlotinib (Drug)
Arm B: Emibetuzumab
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
干预措施: Emibetuzumab (Drug)
Arm A: Emibetuzumab plus Erlotinib
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
干预措施: Emibetuzumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
时间窗: Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Up to 15 Months)
ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) \* 100.
次要结局
- Progression Free Survival (PFS)(Baseline to Objective Disease Progression or Death (Up to 24 Months))
- Time to Progressive Disease(Baseline to Objective Disease Progression (Up to 24 Months))
- Change in Tumor Size (CTS)(Baseline to Measurement with Smallest Tumor Size (Up to 24 Months))
- Secondary: Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)](Baseline to Objective Disease Progression or Participant Stops Study (Up to 24 Months))
- Duration of Response (DoR)(Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months))
- Overall Survival (OS)(Baseline to Death Due to Any Cause (Up to 24 Months))
- Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)(Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months))
- Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)(Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months))
- Change From Baseline in EuroQol 5-Dimensional Scale (EQ-5D)(Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months))
- Pharmacokinetics (PK): Area Under the Concentration (AUC) of Emibetuzumab(Cycle1 Day 1 (C1 D1): Pre-dose and End of infusion; C1 D8: Pre-dose; C1 D15, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15: Pre-dose and End of Infusion)
- Number of Participants With Anti-Emibetuzumab Antibody (ADA) Response(Baseline through 30-Day Follow-Up (Up to 24 Months))