2023-507263-19-00招募中3 期
A Randomized Phase 3 Study of MRTX849 versus Docetaxel in Patients with Previously Treated Non-Small Cell Lung Cancer with KRAS G12C Mutation
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 557
- 试验地点
- 118
- 主要终点
- Progression-free Survival (PFS) Defined as time from randomization until disease progression or death from any cause, whichever occurs first.
研究概览
简要总结
This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.
- •Candidacy to receive treatment with docetaxel.
- •Crossover Inclusion Criteria: Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR
- •Crossover Inclusion Criteria: ECOG performance status 0 - 2.
排除标准
- •Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, sotorasib).
- •Active brain metastases
- •Crossover Exclusion Criteria: Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.
结局指标
主要结局
Progression-free Survival (PFS) Defined as time from randomization until disease progression or death from any cause, whichever occurs first.
Progression-free Survival (PFS) Defined as time from randomization until disease progression or death from any cause, whichever occurs first.
次要结局
- Secondary efficacy endpoints:- Overall Survival (OS)− Objective Response Rate (ORR),− Duration of Response (DOR), and− 1-Year Survival Rate.
- Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events (AEs), laboratory abnormalities, and number of patients discontinuing study treatment due to an adverse event.
- Population PK parameters of MRTX849.
- Patient Reported Outcome (PRO) scores using the following:− Lung Cancer Symptom Scale (LCSS), and− European Quality of Life Five Dimensions Questionnaire(EQ-5D-5L).
研究者
Mirati Study Locator
Scientific
Mirati Therapeutics Inc.
研究点 (118)
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