A Phase II, Open-label, Multicenter and Multi-cohorts Study to Evaluate the Efficacy and Safety of PLB1001 in Advanced Non-small Cell Lung Cancer With c-Met Dysregulation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This is a Phase II, open-label, multicenter and multi-cohorts study of PLB1001 administered orally twice daily to locally advanced/metastatic NSCLC patients with c-Met dysregulation.
详细描述
PLB1001 will be administrated 200mg twice daily. The treatment will be discontinued for the patients who experience disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent. A cycle of study treatment will be defined as 28 days of continuous dosing. The study includes 4 cohorts.
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
- •Signed Informed Consent Form
- •Age≥18 years
- •Histologically or cytologically confirmed advanced non-small cell lung cancer
- •Must have evidence of c-Met dysregulation from the results of molecular pre-screening evaluations
- •At least one measurable lesion as per RECIST v1.1
- •Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1
- •ECOG Performance Status of 0-1.
排除标准
- •Symptomatic central nervous system (CNS) metastases that are neurologically unstable or requiring increasing doses of steroids to control, and patients with any CNS deficits.
- •Clinically significant, uncontrolled heart diseases Unstable angina History of documented congestive heart failure (New York Heart Association functional classification > II) Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 160 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 100 mm Hg Arrhythmias
- •Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia
- •Major surgery within 4 weeks prior to starting PLB1001
- •Previous anti-cancer and investigational agents within 2 weeks before first dose of PLB
- •If previous treatment is a monoclonal antibody, then the treatment must be discontinued at least 4 weeks before first dose of PLB1001
- •Pregnant or nursing women
- •Involved in other clinical trials < 2 weeks prior to Day. If previous treatment of clinical trial is a monoclonal antibody, then the treatment must be discontinued at least 4 weeks before first dose of PLB1001.
研究组 & 干预措施
PLB1001
Subjects will receive 200mg of PLB1001 twice daily in cycles of 28-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
干预措施: PLB1001 (Drug)
结局指标
主要结局
Objective response rate
时间窗: 2 years
Objective response rate will be determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Objective response rate is defined as the percentage of patients who experienced either a complete response (CR) or partial response (PR) from first administration of trial treatment to first observation of progressive disease (PD). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
次要结局
- Progression free survival(2 years)
- Overall survival(4 years)
- Occurrence of Treatment emergent adverse event (TEAEs)(2 years)
- Time to response(2 years)
- Disease control rate(2 years)
- Duration of response(2 years)
- Maximum Plasma concentration (Cmax) of drug(Cycle 1, Day 1 and on Cycle 1, Day 15)