癌研連線CancerLink
進行中（不再收案） NCT03333343

EGF816 聯合選定標靶藥物於 EGFR 突變非小細胞肺癌的研究

非小細胞肺癌Phase IIII 期IV 期EGFRBRAFMET

本研究旨在評估在 EGF816 基礎上加入 INC280、trametinib、ribociclib、gefitinib 或 LXH254 於晚期表皮生長因子受體突變（EGFR 突變）非小細胞肺癌成人患者的安全性、耐受性及初步療效。

適應症：EGFR-mutant Non-small Cell Lung Cancer

收案條件

納入條件

  • Patients must have histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) EGFR mutant (ex19del, L858R) NSCLC.
  • Requirements of EGFR mutation status and prior lines of treatment:
  • Treatment naive patients, who have locally advanced or metastatic NSCLC with EGFR sensitizing mutation (e.g., L858R and/or ex19del), have not received any systemic antineoplastic therapy for advanced NSCLC and are eligible to receive EGFR TKI treatment. Patients with EGFR exon 20 insertion/duplication are not eligible. Note: patients who have received only one cycle of chemotherapy in the advanced setting are allowed.
  • Patients who have locally advanced or metastatic NSCLC with EGFR sensitizing mutation AND an acquired T790M mutation (e.g., L858R and/or ex19del, T790M+) following progression on prior treatment with a 1st-generation EGFR TKI or 2nd-generation EGFR TKI. These patients may not have received more than 4 prior lines of antineoplastic therapy in the advanced setting, including EGFR TKI, and may not have received any agent targeting EGFR T790M mutation (i.e., 3rd-generation EGFR TKI).
  • Patients who have locally advanced or metastatic NSCLC with EGFR sensitizing mutation and a "de novo" T790M mutation (i.e., no prior treatment with any agent known to inhibit EGFR including EGFR TKI). These patients may not have received more than 3 prior lines of antineoplastic therapy in the advanced setting, and may not have received any prior 3rd generation EGFR TKI.
  • Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patients must be willing to undergo a new tumor biopsy during therapy on this study, and at screening if an archival tumor sample obtained since the diagnosis of advanced disease (1L patients) or since last treatment failure (2L+ patients) is not available.

排除條件

  • Patients with a history or presence of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis.
  • Patients with unstable brain metastases.
  • Patients with a history of another malignancy.
  • Patients with a known history of human immunodeficiency virus (HIV) seropositivity.
  • Patients with clinically significant, uncontrolled heart disease.
  • Patients participating in additional parallel investigational drug or medical device studies.
  • Prior therapies:
  • Patients who have been treated with EGFR TKI in the adjuvant setting within 6 months, unless acquired EGFR T790M is present in a tumor or blood sample obtained since the discontinuation of the EGFR TKI.
  • Patients who have been treated with prior EGFR TKI targeting T790M (3rd generation).
  • Patients who have been treated with systemic anti-neoplastic therapy within:
  • weeks for fluoropyrimidine monotherapy
  • weeks for nitrosoureas and mitomycin
  • weeks or ≤ 5 half-lives (whichever is shorter) for biological therapy (including monoclonal antibodies) and continuous or intermittent small molecule therapeutics or any other investigational agent

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。