癌研連線CancerLink
进行中（不再招募） NCT03333343

EGF816 联合选定靶向药物于 EGFR 突变非小细胞肺癌的研究

非小细胞肺癌Phase IIII 期IV 期EGFRBRAFMET

本研究旨在评估在 EGF816 基础上加入 INC280、trametinib、ribociclib、gefitinib 或 LXH254 于晚期表皮生长因子受体突变（EGFR 突变）非小细胞肺癌成人患者的安全性、耐受性及初步疗效。

适应症：EGFR-mutant Non-small Cell Lung Cancer

入组条件

纳入标准

  • 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.

排除标准

  • 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

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。