NCT01945021已完成2 期
Phase II, Open Label, Single Arm Study of the Efficacy and Safety of Crizotinib in East Asian Patients With Advanced ALK-Negative NSCLC Harboring a Translocation or Inversion Involving the c-ROS Oncogene (ROS1) Locus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 129
- 试验地点
- 44
- 主要终点
- Independent Radiology Reviewed Overall Objective Response (ORR)
研究概览
简要总结
To assess treatment effectiveness and safety of oral crizotinib administered to East Asian patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a ROS1 positive gene mutation (translocation or inversion) and confirmed negative for an ALK mutation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic
- •treatment-naïve or have received no more than 3 systemic treatment regimen(s)
- •Positive for translocation or inversion events involving the ROS1 gene
- •Negative for translocation or inversion events involving the ALK gene
- •Patients with brain metastases are eligible if asymptomatic, or if treated, must be neurologically stable for at least 2 weeks and are not taking any contraindicated medications
- •Any prior treatment (chemotherapy, radiation [except for palliative], or surgery) must have been completed at least 2 weeks prior to initiation of study medication
- •At least 1 measurable tumor lesion as per RECIST v1.1
- •Female or male, 18 years of age or older
- •ECOG performance status 0 to 1
- •Adequate organ function
- •Signed and dated informed consent
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including completion of the PRO measures
- •Agree to use effective contraception during the study period and for at least 90 days after completion of the study treatment
排除标准
- •Current treatment on another therapeutic clinical trial
- •Prior therapy specifically directed against ALK or ROS1 fusion genes
- •Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease
- •known interstitial fibrosis or interstitial lung disease
- •myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack within 3 months prior to start of study treatment
- •Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade >/=2, uncontrolled atrial fibrillation of any grade, or QTc >470 msec
- •Pregnant or breast feeding
- •Use of drugs or foods that are known potent CYP3A4 inhibitors or inducers
- •Use of other anti-cancer drugs including traditional Chinese medicine on the SFDA list
- •Evidence of active malignancy within last 3 years
研究组 & 干预措施
Crizotinib
Experimental
Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
干预措施: Crizotinib (Drug)
结局指标
主要结局
Independent Radiology Reviewed Overall Objective Response (ORR)
时间窗: Starting from the first dose study treatment until the first documented CR or PR (every 8 weeks then after 8 cycles at every 12 weeks in duration of 94.0 weeks)
Overall objective response (ORR) was defined as the number of patients with a best overall response of confirmed Complete Response or confirmed Partial Response according to RECIST v1.1 (as determined by Independent Radiology Review \[IRR\]), relative to the total population of response-evaluable participants. Per RECIST v1.1, CR: disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis); PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. Confirmed responses were those that persisted on repeat imaging at least 4 weeks after the initial documentation of response.
次要结局
- IRR-Assessed Duration of Response (DR)(From first documentation of objective tumor response to first documentation of objective PD or death due to any cause, whichever occurred first (every 8 weeks then after 8 cycles at every 12 weeks in duration of 151.3 weeks))
- IRR-Assessed Time to Tumor Response (TTR)(From date of first dose of crizotinib to first documentation of objective response was observed (every 8 weeks then after 8 cycles at every 12 weeks in duration of 151.3 weeks))
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs, Treatment Emergent Treatment Related AEs and SAEs, Grade 3 or 4 Treatment Emergent AEs and Grade 3 or 4 Treatment Emergent Treatment Related AEs(Baseline up to 28 days after the last dose of study treatment (maximum up to 295.9 weeks))
- IRR Assessed Disease Control Rate (DCR) at 8 Weeks(At 8 weeks after the start of study treatment)
- IRR-Assessed Progression Free Survival (PFS)(From the date of first dose of crizotinib until the first documentation of objective PD or death (every 8 weeks then after 8 cycles at every 12 weeks in duration of 151.3 weeks))
- Overall Survival (OS)(From date of the first dose of crizotinib until the date of death from any cause (up to 291.9 weeks))
- Number of Participants With a Shift in Hematology Laboratory Results From Baseline Grade </=2 to Worst Grade 3 or Grade 4(Baseline up to 28 days after the last dose of study treatment (maximum up to 295.9 weeks))
- Number of Participants With a Shift of Chemistry Laboratory Results From Baseline Grade </=2 to Worst Grade 3 or Grade 4(Baseline up to 28 days after the last dose of study treatment (maximum up to 295.9 weeks))
- Change From Baseline to Cycle 60 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) Scores(Baseline up to Cycle 60)
- Change From Baseline to Cycle 60 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 Scores(Baseline up to Cycle 60)
研究者
研究点 (44)
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