2024-516598-60-00招募中3 期
A Randomized Phase 3 Study of Sitravatinib in Combination with Nivolumab Versus Docetaxel in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer with Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy (SAPPHIRE)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 196
- 试验地点
- 8
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
To compare Overall Survival (OS) in patients with non-squamous NSCLC who have experienced disease progression on or after platinum-based chemotherapy and CIT, treated with sitravatinib and nivolumab versus docetaxel.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Post Treatment
- 盲法
- None
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
- 是
入选标准
- •Diagnosis of Non-Squamous Non-Small Cell Lung Cancer
- •Receipt of at least one but not more than two prior treatment regimens in the advanced setting
- •Prior treatment with PD-1/PD-L1 checkpoint inhibitor therapy and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotheraphy followed by checkpoint inhibitor therapy)
- •Most recent treatment regimen must have included a checkpoint inhibitor therapy with radiographic disease progression on or after treatment
- •Candidate to receive docetaxel as second or third line therapy
排除标准
- •Uncontrolled brain metastases
- •Tumors that have tested positive for EGFR, ROS1, ALK mutations, or ALK fusions
- •Unacceptable toxicity with prior checkpoint inhibitor therapy
- •Receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than maintenance chemotherapy
- •Impaired heart function
结局指标
主要结局
Overall Survival (OS)
Overall Survival (OS)
次要结局
- Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events, laboratory abnormalities, and number of patients discontinuing study treatment due to an adverse event.
- Secondary efficacy endpoints: - Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). - Duration of Response (DOR); - Clinical Benefit Rate (CBR); - Progression-Free Survival (PFS); and - 1-Year Survival Rate.
- Blood plasma concentrations of MGCD516.
- Patient reported outcome (PROs): - Lung Cancer Symptom Scale (LCSS); and - European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).
研究者
Mirati Therapeutics, Inc.
Scientific
Mirati Therapeutics Inc.
研究点 (8)
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