进行中(不再招募) NCT06593522

Anvumetostat 用于 MTAP 缺失晚期 NSCLC 受试者的第二期研究(MTAPESTRY 201)

非小细胞肺癌Phase IIIII 期IV 期EGFRALKROS1KRASHER2BRAFMETRETNTRK

本研究的主要目标为描述由研究者评估的 2 个 anvumetostat 剂量水平的安全性及疗效,并通过盲性独立中央审查(BICR)评估 anvumetostat 单药治疗的疗效。

适应症:MTAP-deleted NSCLC

入组条件

纳入标准

  • Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP) NSCLC
  • Participants will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease.
  • Either an archival tissue sample or an archival block must be available.
  • Life expectancy of greater than 3 months, in the opinion of the investigator.
  • Participants who have had brain metastases and have been appropriately treated with radiation therapy or surgery ending at least 14 days before study day 1 are eligible.
  • Participants with untreated asymptomatic brain metastases smaller or equal to 2 cm in size (per lesion if more than one) and not requiring corticosteroid treatment are eligible.

排除标准

  • Disease Related
  • Tumors harboring the following mutations amenable to targeted therapies: epidermal growth factor receptor (EGFR), ALK receptor tyrosine kinase (ALK), ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), MET proto-oncogene (MET), B-Raf proto-oncogene (BRAF), RET proto-oncogene (RET), Human epidermal growth factor receptor 2 (HER2/ERBB2), KRAS proto-oncogene G12C (KRAS G12C).
  • Other Medical Conditions
  • Major surgery within 28 days of study day 1.
  • Untreated symptomatic central nervous system (CNS) metastatic disease regardless of size or asymptomatic brain metastases greater than 2 cm per lesion.

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。