癌研連線CancerLink
进行中（不再招募） NCT05261399

Savolitinib 联合 Osimertinib 对比铂类双药化疗用于 Osimertinib 治疗后恶化之非小细胞肺癌参与者的研究

非小细胞肺癌Phase IIIIII 期IV 期EGFRMET

临床研究旨在探讨 savolitinib 联合 osimertinib 对比铂类双药化疗，用于 EGFR 突变、MET 过度表达及／或扩增、局部晚期或转移性 NSCLC 且接受 osimertinib 治疗后恶化之参与者的疗效与安全性。

适应症：Carcinoma、Non-Small-Cell Lung

入组条件

纳入标准

  • Provision of signed and dated written ICF prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses.
  • Participant must be ≥18 years (≥ 19 years of age in South Korea) at the time of signing the informed consent. All genders are permitted.
  • Histologically or cytologically confirmed locally advanced or metastatic NSCLC which is not amenable to curative therapy.
  • Must have at least one documented sensitising EGFR mutation: exon19 deletion, L858R mutation, and/or T790M.
  • Documented radiologic progression on first- or second-line treatment with osimertinib as the most recent anti-cancer therapy.
  • Mandatory provision of FFPE tumour tissue.
  • MET overexpression and/or amplification in tumour specimen collected following progression on prior osimertinib treatment.
  • Measurable disease as defined by RECIST 1.1.
  • Adequate haematological, liver, renal and cardiac functions, and coagulation parameters.
  • ECOG performance status of 0 or 1.

排除标准

  • Predominant squamous NSCLC, and small cell lung cancer.
  • Prior or current treatment with a third-generation EGFR-TKI other than Osimertinib.
  • Prior or current treatment with savolitinib or another MET inhibitors.
  • Spinal cord compression or brain metastases, unless asymptomatic and are stable.
  • History or active leptomeningeal carcinomatosis.
  • Unresolved toxicities from any prior therapy greater than CTCAE Grade 1 and prior platinum-therapy related Grade 2 neuropathies with the exception of alopecia and haemoglobin ≥ 9.0 g/dL.
  • Active/unstable cardiac diseases currently or within the last 6 months, clinically significant ECG abnormalities, and/or factors/medications that may affect QTc intervals.
  • History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement.
  • Known serious active infection including, but not limited to, tuberculosis, or HIV, HBV or HCV or gastrointestinal disease.
  • Receipt of live attenuated vaccine (including against COVID-19) within 30 days prior to the first dose of study intervention.
  • Past medical history of ILD, drug-induced ILD, radiation pneumonitis, which required steroid treatment, or any evidence of clinically active ILD.
  • Participants currently receiving medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP)3A4 or strong inhibitors of CYP1A2.

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。