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)

Mirati Therapeutics, Inc.0 个研究点目标入组 532 人开始时间: 2020年6月16日最近更新: 2024年3月4日

适应症

试验速览

暂无简介。

•1. Diagnosis of Non-Squamous Non-Small Cell Lung Cancer
•2. Receipt of at least one but not more than two prior treatment regimens in the advanced setting
•3. 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)
•4. Most recent treatment regimen must have included a checkpoint inhibitor therapy with radiographic disease progression on or after treatment
•5. Candidate to receive docetaxel as second or third line therapy
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 266
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 266

•1. Uncontrolled brain metastases
•2. Tumors that have tested positive for EGFR, ROS1, ALK mutations, or ALK fusions
•3. Unacceptable toxicity with prior checkpoint inhibitor therapy
•4. Receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than maintenance chemotherapy
•5. Impaired heart function

发起方