进行中(不再招募) NCT04793958

MRTX849 联合 cetuximab 对比化疗用于 KRAS G12C 突变晚期结直肠癌患者的第三期研究(KRYSTAL-10)

结直肠癌Phase IIIIII 期IV 期EGFRKRAS

研究 CA239-0006 是一项开放标签、随机第三期临床试验,比较 MRTX849 联合 cetuximab 与化疗在 KRAS G12C 突变结直肠癌患者第二线治疗中的疗效。

适应症:Advanced Colorectal Cancer、Metastatic Colorectal Cancer

入组条件

纳入标准

  • Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue.
  • Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment.

排除标准

  • Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510).
  • Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).
  • Active brain metastasis

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。