A Phase II/III Randomized Study of Rilotumumab Plus Erlotinib Versus Erlotinib as Second Line Therapy for C-Met Positive Patients With Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 620
- 主要终点
- Objective Response Rate (Confirmed and Unconfirmed, Complete and Partial) Between Arms
研究概览
简要总结
This randomized phase II/III compares rilotumumab when given together with erlotinib hydrochloride against erlotinib hydrochloride alone in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a sub-study that includes all screened patients positive for the met proto-oncogene (MET)/hepatocyte growth factor (HGF) biomarker. HGF can interact with MET and can cause tumor cells to grow more quickly. Rilotumumab may decrease the activity of HGF and may be able to shrink tumors. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving rilotumumab with erlotinib hydrochloride works better than erlotinib hydrochloride alone (standard treatment) in treating squamous cell lung cancer.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate if there is sufficient evidence to continue to the phase III component of S1400E by comparing investigator-assessed progression-free survival (IA-PFS) between rilotumumab plus erlotinib versus erlotinib in patients registered to S1400E. (Phase II) II. To determine if there is both a statistically and clinically-meaningful difference in IA-PFS between patients randomized to receive rilotumumab plus erlotinib versus erlotinib. (Phase III) III. To compare overall survival (OS) in patients randomized to rilotumumab plus erlotinib versus erlotinib. (Phase III)
SECONDARY OBJECTIVES:
I. To compare response rates (confirmed and unconfirmed, complete and partial responses) among patients randomized to receive rilotumumab plus erlotinib versus erlotinib. (Phase II) II. To evaluate the frequency and severity of toxicities associated with rilotumumab plus erlotinib versus erlotinib. (Phase II) III. To compare the response rates (confirmed and unconfirmed, complete and partial) among patients randomized to receive rilotumumab plus erlotinib versus erlotinib. (Phase III) IV. To evaluate the frequency and severity of toxicities associated with rilotumumab plus erlotinib versus erlotinib. (Phase III)
TERTIARY OBJECTIVES:
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
- •Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
- •Patients must be assigned to S1400E; S1400E biomarker eligibility defined as C-MET positive is defined as follows:
- •Analyte: C-MET
- •Assay: Immunohistochemistry (IHC)
- •Eligible definition: IHC positive based on Dako MET-IHC pharm DX kit
- •If randomized to arm I rilotumumab plus erlotinib, patients must be willing to provide blood specimens for anti-rilotumumab anti-body testing
- •Patients must not have peripheral edema > grade 1 at the time of sub-study registration
- •Patients must not have received prior treatment with MET pathway, inhibitors or EGFR inhibitors (e.g., erlotinib)
- •Patients must have total bilirubin =< 1.5 x institutional upper limits of normal (IULN) within 28 days prior to sub-study registration
- •Patients must not have abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjorgren?s syndrome), congenital abnormality (e.g., Fuch?s dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose), and/or abnormal corneal sensitivity test (Schirmer test or similar tear production test)
- •Patients must not be taking, nor plan to take while on protocol treatment and for 14 days post the last dose of study treatment, drugs, herbal supplements or foods that are known to be strong/moderate CYP3A4 substrates
排除标准
- 未提供
研究组 & 干预措施
Arm I (rilotumumab, erlotinib)
Patients receive rilotumumab IV over 60-120 minutes on day 1 and erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AND INTERVENTION 11/25/2014)
干预措施: Erlotinib Hydrochloride (Drug)
Arm I (rilotumumab, erlotinib)
Patients receive rilotumumab IV over 60-120 minutes on day 1 and erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AND INTERVENTION 11/25/2014)
干预措施: Laboratory Biomarker Analysis (Other)
Arm I (rilotumumab, erlotinib)
Patients receive rilotumumab IV over 60-120 minutes on day 1 and erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AND INTERVENTION 11/25/2014)
干预措施: Rilotumumab (Biological)
Arm II (erlotinib)
Patients receive erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AND INTERVENTION 11/25/2014)
干预措施: Erlotinib Hydrochloride (Drug)
Arm II (erlotinib)
Patients receive erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AND INTERVENTION 11/25/2014)
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Objective Response Rate (Confirmed and Unconfirmed, Complete and Partial) Between Arms
时间窗: Up to 3 years
Investigator-assessed Progression-free Survival Between Arms
时间窗: From date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 18 months since completion of accrual
A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to investigator-assessed progression-free survival, comparing the two treatment arms.
次要结局
- Frequency and Severity of Toxicities Associated With Investigational Therapy Versus Standard of Care(Up to 3 years)