A Randomized, Double-blind, Phase 3 Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib (RMC-9805) as First Line Treatment in Patients With Metastatic Non-squamous RAS G12D-Mutated Non-small Cell Lung Cancer (RASolve 308)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with pembrolizumab and platinum-based chemotherapy doublet compared to placebo in combination with pembrolizumab and platinum-based chemotherapy doublet.
详细描述
This is a Phase 3, global, randomized, double-blind study designed to evaluate whether treatment with zoldonrasib in combination with pembrolizumab and platinum-based chemotherapy doublet will improve progression-free survival compared to placebo in combination with pembrolizumab and platinum-based chemotherapy doublet when given to patients with previously untreated, 1L metastatic RAS G12D-mutated, non-squamous non-small cell lung cancer (NSCLC).
Patients will be randomized to one of two arms: zoldonrasib + pembrolizumab + platinum-based chemotherapy doublet (Arm A) or placebo + pembrolizumab + platinum-based chemotherapy doublet (Arm B).
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
- Double (Participant, Investigator)
盲法说明
Chemotherapy and pembrolizumab administration will be open label. This study is double-blind with respect to zoldonrasib versus placebo. Treatment assignments will remain blinded to Investigator, study center staff, patient, Sponsor and study vendors.
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
- •Histologically or cytologically confirmed, previously untreated metastatic non-squamous NSCLC.
- •Known PD-L1 status
- •Documented RAS G12D mutation status.
- •Measurable disease per RECIST v1.
- •Adequate organ function (bone marrow, liver, kidney, coagulation, thyroid).
- •Able to take oral medications.
排除标准
- •Prior treatment with systemic anticancer therapy in metastatic setting for NSCLC.
- •Prior systemic therapy with any RAS-directed therapy.
- •Untreated (symptomatic or asymptomatic) central nervous system metastatic disease.
- •Any conditions that may affect the ability to take or absorb study drug.
- •Major surgery on or within 28 days prior to randomization.
- •Patient is unable or unwilling to comply with protocol-required study visits or procedures.
- •Additional inclusion and exclusion criteria may apply
结局指标
主要结局
Progression free survival (PFS)
时间窗: Up to approximately 5 years
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per response evaluation criteria in solid tumors (RECIST) v1.1 by blinded independent central review (BICR).
次要结局
- Overall survival (OS)(Up to approximately 5 years)
- Objective response rate (ORR)(Up to approximately 5 years)
- Duration of response (DOR)(Up to approximately 5 years)
- Incidence of adverse events (AEs)(Up to approximately 5 years)
- Changes in vital signs(Up to approximately 5 years)
- Changes in clinical laboratory test values(Up to approximately 5 years)
- Quality of life as assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(Up to approximately 5 years)
- Time to confirmed deterioration in physical function and global health status, as measured by EORTC QLQ-C30(Up to approximately 5 years)
- Changes in Non-Small Cell Lung Cancer (NSCLC)-related symptoms, measured by the NSCLC-Symptom Assessment Questionnaire (NSCLC-SAQ)(Up to approximately 5 years)
- Time to Confirmed Deterioration of NSCLC-related symptoms, as measured by NSCLC-SAQ(Up to approximately 5 years)
- Concentration of zoldonrasib in Arm A(Up to Cycle 5 Day 1 (each cycle is 21 days))