A Randomized Study of Two Dosing Regimens of Adagrasib in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 282
- 主要终点
- Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
研究概览
简要总结
This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.
详细描述
CA239-0012 is a phase 2 study of adagrasib monotherapy in which patients are randomized between two dosing regimens. The study will 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •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.
- •Patients with brain lesions are not eligible if 1) any untreated brain lesions are > 2.0 cm in size 2) any brainstem lesions are present 3) ongoing steroid dosing >10 mg daily prednisone (or equivalent) and 4) poorly controlled (> 1/week) generalized or complex partial seizures or neurologic progression/instability due to brain lesions.
- •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.
研究组 & 干预措施
Adagrasib 400mg BID
Adagrasib 400mg BID with food
干预措施: Adagrasib (Drug)
Adagrasib 600mg BID
Adagrasib 600mg BID without regard to food
干预措施: Adagrasib (Drug)
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).
时间窗: 30 months
ORR evaluation of subjects treated with adagrasib 600 mg BID without regard to food versus 400 mg BID with food having NSCLC with KRAS G12C mutation (Study Population) will be completed per blinded independent central radiology (BICR) review. Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of adagrasib until last dose of adagrasib.
次要结局
- Evaluate Duration of Response (DOR).(30 months)
- Evaluate Overall Survival (OS).(45 months)
- Evaluate Progression Free Survival (PFS).(30 months)
- Population pharmacokinetic (PK) Model Derived Area Under the Curve During the Dosing Interval at Steady State (AUCtau,ss).(Pre-dose and 4-6 hours post dose; up to 6 months.)
- Patient -reported quality of life during adagrasib administration from first dose to End of Treatment visit.(30 months)
- Safety and tolerability in the study population.(30 months)
- Patient-reported symptoms during adagrasib administration from first dose to 28 days after last dose of adagrasib.(30 months)