2025-521681-10-00尚未招募2 期
A Phase 2, Open-Label, Multicenter Study of Zoldonrasib(RMC-9805) in Previously Treated Patients with RAS G12DMutant Non-Small Cell Lung Cancer (NSCLC) – Subprotocol D
Revolution Medicines Inc.41 个研究点 分布在 9 个国家目标入组 84 人开始时间: 2025年9月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 41
- 主要终点
- Confirmed ORR per RECIST v1.1 as assessed by BICR
研究概览
简要总结
To evaluate the ORR as assessed by RECIST v1.1 criteria of zoldonrasib monotherapy in patients with RAS G12D-mutant NSCLC who have been previously treated with systemic 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
- •Patients that are at least 18 years of age
- •Patients that have NSCLC with RAS-G12D mutation
- •Patients that have had cancer treatment before or are not able to tolerate regular treatments.
- •Patients that have at least 1 measurable tumor (lesion).
- •Patients that have adequate organ function (bone marrow, liver, kidney) and blood clotting.
排除标准
- •Patients that have primary brain and spinal cord tumor.
- •Patients thathave gastrointestinal problems that may affect absorption of RMC-9805
- •Patients thathad any major surgery in the last 4 weeks.
- •Patients that have any other medical condition that may interfere with the study medicine.
- •Patient that have a history of severe allergic reactions to the study medicine.
- •Patients that have previously taken targeted therapy for KRAS mutation.
结局指标
主要结局
Confirmed ORR per RECIST v1.1 as assessed by BICR
Confirmed ORR per RECIST v1.1 as assessed by BICR
次要结局
- •PFS
- • OS
- • DOR
- • TTR
- • DCR
- • PFS rate at 6 months and 12 months and OS rate at 12 months
- • Incidence of TEAEs, SAEs, and changes from baseline in clinical laboratory values and vital signs.
- • Zoldonrasib blood concentration over time
研究者
Melanie Caruno
Scientific
Revolution Medicines Inc.
研究点 (41)
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