RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 Versus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 590
- 试验地点
- 226
- 主要终点
- Overall survival (OS) in the RAS G12X-C population
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.
详细描述
This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve progression free survival (PFS) or overall survival (OS) compared to docetaxel chemotherapy in patients with NSCLC who were previously treated. Patients will be randomized in a 1:1 ratio to receive daraxonrasib or docetaxel chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The central reader of the tumor scans will be masked to the patients' treatment arm.
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
- •At least 18 years old and has provided informed consent.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Pathologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy.
- •Measurable disease per RECIST v1.
- •Adequate organ function (bone marrow, liver, kidney, coagulation).
- •One to two prior lines of therapy including an anti-PD-1/anti-PD(L)-1 agent and platinum-based chemotherapy.
- •Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
- •Able to take oral medications.
排除标准
- •Prior therapy with direct RAS-targeted therapy or docetaxel.
- •Untreated central nervous system (CNS) metastases.
- •Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function).
- •Ongoing anticancer therapy.
- •Pregnant or breastfeeding.
研究组 & 干预措施
docetaxel
Patients randomized to the comparator control arm will receive docetaxel as the standard of care therapy.
干预措施: docetaxel (Drug)
daraxonrasib
study drug
干预措施: daraxonrasib (Drug)
结局指标
主要结局
Overall survival (OS) in the RAS G12X-C population
时间窗: Up to approximately 4 years
OS is defined as the time from randomization until death from any cause.
Progression free survival (PFS) per Investigator in the RAS G12X-C population (i.e RAS G12X excluding G12C)
时间窗: Up to approximately 4 years
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by Investigator.
Overall survival (OS) in the RAS G12X-C population
时间窗: Up to approximately 4 years
OS is defined as the time from randomization until death from any cause.
次要结局
- Objective response per Investigator in the RAS (G12X-C) and RAS (MUT) populations(Up to approximately 4 years)
- Objective response per BICR in the RAS (G12X-C) and RAS (MUT) populations(Up to approximately 4 years)
- PFS in the RAS (MUT) population per Investigator(Up to approximately 4 years)
- OS in the RAS (MUT) population(up to approximately 4 years)
- PFS per BICR in the RAS (G12X-C) and RAS (MUT) populations(Up to approximately 4 years)
- Duration of response (DOR) per Investigator and BICR in the RAS (G12X-C) and RAS (MUT) populations(Up to approximately 4 years)
- Time to response (TTR) per Investigator and per BICR in the RAS (G12X-C) and RAS (MUT) populations(Up to approximately 4 years)
- Treatment effect on quality of life (QoL) using EORTC QLQ-LC13 In the RAS (G12X-C) and RAS (MUT) populations(Up to approximately 4 years)
- Treatment effect on quality of life (QoL) using EORTC QLQ-C30 In the RAS (G12X-C) and RAS (MUT) populations(Up to approximately 4 years)
- Safety and tolerability in the RAS (G12X-C) and RAS (MUT) population(Up to approximately 4 years)
- PK characterization of daraxonrasib In the RAS (MUT) population(Up to approximately 4 years)