2023-503523-25-00招募中2 期
A Randomized Study of Two Dosing Regimens of Adagrasib in Patients with Previously Treated Non-Small Cell Lung Cancer with KRAS G12C Mutation
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 57
- 主要终点
- Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per BICR.
研究概览
简要总结
To evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID without regard to food versus 400 mg BID with food) in patients with NSCLC with KRAS G12C mutation and who have received prior treatment with a platinum-based regimen and immune checkpoint inhibitor therapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Are at least 18 years old (or old enough to legally make their own treatment decisions, according to local laws).
- •Have advanced NSCLC or metastatic NSCLC (NSCLC that started in the lungs and then spread to other parts of the body) with the KRAS G12C mutation.
- •Have had previous treatment with 1) chemotherapy that included a drug called cisplatin or a drug called carboplatin and 2) a type of drug called an immune checkpoint inhibitor.
- •Have recovered from their prior treatment and blood tests are within a safe range.
排除标准
- •Have had previous treatment with a drug that targets KRAS G12C.
- •Have cancer that can potentially be removed with surgery.
- •Have certain medical conditions or need to take certain medications that, in the opinion of a trial doctor, could make it unsafe for them to participate or difficult to complete the trial assessments, or are pregnant.
结局指标
主要结局
Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per BICR.
Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per BICR.
次要结局
- Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, laboratory abnormalities, and number of patients modifying or discontinuing study treatment due to an AE.
- Secondary efficacy endpoints: Overall Survival (OS), Progression-Free Survival (PFS) per BICR, Duration of Response (DOR) per BICR.
- Summary statistics of adagrasib plasma concentrations.
- Patient-Reported Outcome (PRO) scores using PRO-CTCAE and EQ-5D-5L.
研究者
GSM-CT
Scientific
Mirati Therapeutics Inc.
研究点 (57)
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