癌研連線CancerLink
招募中 NCT07185997

与研究者选择EGFR抑制剂作为一线治疗相比，评估Firmonertinib在患有EGFR P-环和α C-螺旋压缩（ PACC ）罕见突变的局部晚期或转移性NSCLC的参与者中的有效性和安全性的研究

非小细胞肺癌Phase IIIIII 期IV 期EGFR

与研究者选择奥西替尼（ 80 mg QD ）或阿法替尼（ 40 mg QD ）相比，评估剂量水平为240 mg QD的firmonertinib在患有EGFR PACC突变的局部晚期或转移性NSCLC参与者中的有效性和安全性的全球、随机、多中心、开放标签研究。

适应症：Non-Small-Cell Lung Cancer、Metastatic Non-Small-Cell Lung Cancer、Advanced Non-Small-Cell Lung Cancer、EGFR P-Loop and Alpha C-Helix Compressing、EGFR PACC、EGFR Uncommon Mutations

入组条件

纳入标准

  • Key Eligibility Criteria:
  • Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
  • Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing.
  • No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).
  • Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months.
  • Patients with asymptomatic CNS metastases are eligible.

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。