NCT02368990撤回不适用
T-STAR - T790M Mutation Positive 2nd Line STandard of cAre Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- AstraZeneca
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The aim of the study is to collect real world information on patients with locally advanced or metastatic non small cell lung cancer (NSCLC) who progressed after first line treatment with an approved Tyrosine-Kinase Inhibitor (TKI), who are known to be T790M positive and have been prescribed second line platinum-based chemotherapy (Pemetrexed + Cisplatin /Carboplatin).
详细描述
The study is an observational prospective cohort study that plans to enroll approximately 200 patients worldwide. There are Epidermal Growth Factor Receptor (EGFR) mutations known to be associated with EGFR-targeted TKI sensitivity ( Ex19Del, L858R, L861Q, and G719X). Further tests on biopsied tissue or cytology at progression after treatment with an approved EGFR targeted TKI are used to determine positivity to T790M mutation. Primary objectives of the study are :
- To estimate overall survival
- To estimate disease progression (as assessed and defined by physician)
- To estimate time on treatment by line of therapy
- To describe time to subsequent therapies (or death)
- To describe healthcare resource utilization patterns
- To capture patient reported symptoms, functioning, and health-related quality of life (HRQoL) data using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items (EORTC QLQ-LC13)
- To describe the use of pemetrexed + cisplatin/carboplatin as the 2nd line treatment
- To describe treatment patterns for 3rd line treatment and beyond
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Provision of signed and dated written informed consent prior to any study specific procedure.
- •Patients with histologically- or cytologically-documented NSCLC who present with Stage IIIB/ Stage IV disease.
- •Evidence of radiological disease progression following 1st line treatment for advanced/metastatic NSCLC with an approved EGFR-targeted TKI monotherapy without any additional concurrent NSCLC treatment. Chemotherapy received in the adjuvant setting is permitted.
- •Patients prescribed platinum based doublet chemotherapy (pemetrexed + cisplatin/carboplatin) for 2nd line treatment of NSCLC. Treatment must have been selected by physician as part of routine standard of care, prior to confirming eligibility for the study. Patient must be enrolled into the study within two cycles of beginning treatment. Treatment must be given in accordance with local prescribing information.
- •Confirmation prior to enrolment into the study that the tumour harbours the following EGFR mutations known to be associated with EGFR-targeted TKI sensitivity: Ex19Del, L858R, L861Q, and G719X.
- •Patients must have had confirmation that tumour is T790M mutation positive from a biopsy or cytology sample taken after confirmed disease progression on 1st line treatment with an approved EGFR-targeted TKI.
- •WHO performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
排除标准
- •Treatment with any of the following:
- •Prior treatment with more than one line of treatment for advanced NSCLC.
- •Major surgery (excluding placement of vascular access) within 4 weeks prior to enrolment.
- •Palliative radiotherapy with a limited field of radiation within 1 week prior to enrolment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed within 4 weeks prior to enrolment.
- •Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to enrolment.
- •Patients who are known to be entering an alternative interventional clinical study at the time of enrolment into this study will be excluded. However, inclusion in this study does not preclude participation in any other clinical study after enrolment. Patients who participate in clinical studies after enrolment into this study will be followed to the extent possible as permitted by the sponsor of that clinical study.
- •Involvement in the planning and conduct of the study (applies to AstraZeneca staff or staff at the site).
- •Judgment by the physician that the patient should not participate in the study if the patient is unlikely to comply with procedures, restrictions, and requirements.
结局指标
主要结局
Overall Survival
时间窗: 24 months from last subject in
This will be assessed as the time from the start date of 2nd line chemotherapy until death due to any cause or censoring (at end of 24 months).To assess efficacy of permetrexed + cisplatinum/carboplatin as the 2nd line of treatment of NSCLC.
次要结局
- Response to Therapy as assessed by the physician(24 months from last subject in)
- Time on treatment by line of therapy and between therapies(24 months from last subject in)
- Admission of planned/unplanned hospitalizations, emergency department visits and outpatient/physician visits(24 months from last subject in)
- Time to symptom deterioration(24 months from last subject in)
- Symptom Improvement Rate(24 months from last subject in)
- Duration of Response as defined by the physician(24 months from last subject in)
- Progression Free Survival(24 months from last subject in)
研究者
研究点 (1)
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