EUCTR2020-003101-58-AT招募中1 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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 806
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Phase 2: Histologically confirmed diagnosis of unresectable or metastatic
- •NSCLC with KRAS G12C mutation and any PD-L1 TPS
- •Phase 3: Histologically confirmed diagnosis of unresectable or metastatic
- •NSCLC (squamous or nonsquamous) with KRAS G12C mutation and PDL1 TPS = 50% confirmed (qualifying results using Qiagen therascreen
- •KRAS RGQ PCR kit and PharmDx 22C3 must be obtained either locally or
- •centrally).
- •Phase 3: Presence of evaluable or measurable disease per RECIST
- •version 1.1.
- •Phase 3: CNS Inclusion–- Based on screening brain imaging, patients
- •must have one of the following:
- •1. No evidence of brain metastases
- •2. Untreated brain metastases not needing immediate local therapy
- •3. Previously treated brain metastases not needing immediate local
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 403
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 403
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., sotorasib)
- •Phase 2 and Phase 3: Radiation to the lung > 30 Gy within 6 months
- •prior to the first dose of study treatment.
- •Phase 2: Active brain metastases
- •Phase 3: Patients with known central nervous system (CNS) lesions
- •must not have any of the following:
- •1. Any untreated brain lesions > 1.0 cm in size
- •2. Any brainstem lesions
- •3. Ongoing use of systemic corticosteroids for control of symptoms of
- •brain lesions at a total daily dose of > 10 mg of prednisone (or
- •equivalent) prior to randomization.
- •4. Have poorly controlled (> 1/week) generalized or complex partial
- •seizures, or manifest neurologic progression due to brain lesions
- •notwithstanding CNS-directed therapy
研究者
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