癌研連線CancerLink
招募中 NCT07185997

與研究者選擇EGFR抑制劑作為一線治療相比，評估Firmonertinib在患有EGFR P-環和α C-螺旋壓縮（ PACC ）罕見突變的局部晚期或轉移性NSCLC的參與者中的有效性和安全性的研究

非小細胞肺癌Phase IIIIII 期IV 期EGFR

與研究者選擇奧西替尼（ 80 mg QD ）或阿法替尼（ 40 mg QD ）相比，評估劑量水平為240 mg QD的firmonertinib在患有EGFR PACC突變的局部晚期或轉移性NSCLC參與者中的有效性和安全性的全球、隨機、多中心、開放標籤研究。

適應症：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

收案條件

納入條件

  • 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.

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。