進行中(不再收案) NCT06593522

Anvumetostat 用於 MTAP 缺失晚期 NSCLC 受試者的第二期研究(MTAPESTRY 201)

非小細胞肺癌Phase IIIII 期IV 期EGFRALKROS1KRASHER2BRAFMETRETNTRK

本研究的主要目標為描述由研究者評估的 2 個 anvumetostat 劑量水平的安全性及療效,並透過盲性獨立中央審查(BICR)評估 anvumetostat 單藥治療的療效。

適應症:MTAP-deleted NSCLC

收案條件

納入條件

  • 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.

排除條件

  • 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.

收案條件維持 ClinicalTrials.gov 原始英文登錄資料,實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源:ClinicalTrials.gov,每兩週自動更新,最後同步:2026年10月8日。