A Phase II Study to Assess the Safety and Efficacy of D-0316 in Patients With Locally Advanced/Metastatic Non Small Cell Lung Cancer Whose Tumors Are Epidermal Growth Factor Receptor Mutation Positive
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Objective response rate based on independent radiology review
研究概览
简要总结
A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of D-0316 in Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours are Epidermal Growth Factor Receptor Mutation and T790M Mutation Positive
详细描述
This is a phase II, open label, single arm study assessing the safety and efficacy of D-0316 (Firstly, D-0316 was orally given 75mg for a cycle(21 days), if tolerated, the dose will be increased to 100mg. Otherwise, the dose will be maintained at 75mg.) in patients with a confirmed diagnosis of Epidermal Growth Factor Receptor mutation positive and T790M mutation positive NSCLC,who have progressed following prior therapy with an approved Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) agent. The primary objective of the study is to assess the efficacy of D-0316 by assessment of Objective Response Rate according to RECIST 1.1 by an Independent Central Review.
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
- •Aged at least 18 years.
- •Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic.
- •Radiological documentation of disease progression while on a previous continuous treatment with an first or second generation of EGFR TKI e.g. gefitinib or erlotinib.
- •patients must also have confirmation of tumour T790M mutation status (confirmed positive) after disease progression on the prior EGFR TKI.
- •Eastern cooperative oncology group performance status (ECOG PS) of 0-
- •a minimum life expectancy of 12 weeks.
- •At least one lesion, not previously irradiated during the study screening period, that can be accurately measured at baseline according to RECIST 1.
- •Agree to use routine adequate and effective contraceptive measures during the entire study period and within 6 weeks after the last dose pre-menopausal fertility possible; Female patients need to exclude pregnancy (ie negative pregnancy test) and in non-lactation period.
排除标准
- •Treatment with a first or second generation of EGFR-TKI within 10 days of study entry; previous treatment with a third generation of EGFR-TKI.
- •Unresolved toxicities from prior therapy.
- •Unstable spinal cord compression/brain metastases.
- •Severe/uncontrolled systemic diseases, including uncontrolled hypertension, bleeding diatheses or infection.
- •QTcF≥470 msec（female）or QTcF≥450 msec（male）during the screening period.
- •Severe respiratory diseases such as interstitial lung disease, severe asthma, pulmonary embolism, etc.
- •previous treatment with 2 or more lines of Chemotherapy or immunotherapy.
研究组 & 干预措施
D-0316
Firstly, D-0316 was orally given 75mg for a cycle(21 days), if tolerated, the dose will be increased to 100mg. Otherwise, the dose will be maintained at 75mg.
干预措施: D-0316 (Drug)
结局指标
主要结局
Objective response rate based on independent radiology review
时间窗: 24 months
ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).
次要结局
- Progression-free survival (PFS) as assessed by independent radiology review and investigator(36 months)
- Overall survival (OS)(36 months)
- Disease control rate(DCR)(24 months)
- Duration of response(DoR)(24 months)
- Intracranial Progression-free survival(iPFS)(36 months)
- Intracranial objective response rate(iORR)(24 months)