癌研連線CancerLink
招募中 NCT04613596

Adagrasib单药治疗和与Pembrolizumab联合治疗的2期试验，以及Adagrasib在KRAS G12C突变KRYSTAL-7患者中联合治疗的3期试验

非小细胞肺癌Phase IIIII 期IV 期KRASPD-L1

本研究的第2阶段部分评估MRTX849单药治疗和与pembrolizumab合并治疗在伴有KRAS G12C突变和任何PD-L1 TPS的晚期NSCLC患者群组中的有效性和安全性，这些患者是一线治疗的候选者。 研究的第3阶段部分比较了adagrasib联合pembrolizumab与pembrolizumab在不可切除、局部晚期或转移性鳞状或

适应症：Advanced Non-Small Cell Lung Cancer、Metastatic Non-Small Cell Lung Cancer

入组条件

纳入标准

  • 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 squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\>=50%
  • Phase 3: Presence of measurable disease per RECIST1.1
  • 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 2: Active brain metastases
  • Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:
  • Any untreated brain lesions \> 2.0 cm in size
  • Any brainstem lesions
  • Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \> 10 mg of prednisone (or equivalent) prior to randomization.
  • Have poorly controlled (\> 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 \> 30 Gy within 6 months prior to the first dose of study treatment

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。