CTRI/2025/10/096678尚未招募3 期
A Phase 2 Trial of Adagrasib Monotherapy and in Combination with Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab in Patients with Advanced Non Small Cell Lung Cancer with KRAS G12C Mutation
Mirati Therapeutics, Inc. a Bristol Myers Squibb Company16 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2025年11月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 550
- 试验地点
- 16
- 主要终点
- To compare efficacy of Adagrasib in combination with pembrolizumab versus pembrolizumab: Progression Free Survival per RECIST 1.1 by Blinded Independent Central Review (BICR) and Overall Survival
研究概览
简要总结
The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50% and who are candidates for first line treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •• Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS more than equal to 50 percentage. • Phase 3: Presence of evaluable or measurable disease per RECIST • Phase 3: CNS Inclusion.
- •Based on screening brain imaging, patients must have one of the following:
- •No evidence of brain metastases
- •Untreated brain metastases not needing immediate local therapy
- •Previously treated brain metastases not needing immediate local therapy.
排除标准
- •• Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).
- •• Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:
- •Any untreated brain lesions more than 1.0 cm in size
- •Any brainstem lesions
- •Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of more than 10 mg of prednisone (or equivalent) prior to randomization.
- •Have poorly controlled (more than 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy • Phase 3: Radiation to the lung more than 30 Gy within 6 months prior to the first dose of study treatment.
结局指标
主要结局
To compare efficacy of Adagrasib in combination with pembrolizumab versus pembrolizumab: Progression Free Survival per RECIST 1.1 by Blinded Independent Central Review (BICR) and Overall Survival
时间窗: 36 months
次要结局
- To evaluate the safety and tolerability in the study population: Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities.(36 months)
- To evaluate the PK of adagrasib administered in the study population: Pharmacokinetics (PK) Blood plasma Adagrasib and potential metabolite concentrations(36 months)
- To evaluate health-related quality of life (HRQOL) and lung cancer specific symptoms in the study population: Patient Reported Outcomes to measure quality of life(36 months)
- Progression Free Survival per RECIST 1.1 by Investigator: Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.(36 months)
- Duration of Response (DOR) per RECIST 1.1 by Investigator and BICR:Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.(36 months)
- Objective Response Rate (ORR) per RECIST 1.1 by Investigator and BICR: Defined as the percent of patients documented to have a confirmed CR or PR.(36 months)
研究者
研究点 (16)
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