本研究旨在评估间质上皮转化因子（MET）抑制剂 tepotinib 联合第三代 EGFR 抑制剂 osimertinib 于晚期或转移性非小细胞肺癌（NSCLC）参与者中的抗肿瘤活性、安全性、耐受性及药物动力学（PK）。
适应症：Non-small Cell Lung Cancer
入组条件
纳入标准
- Locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) histology (confirmed by either histology or cytology) with documented activating Epidermal Growth Factor Receptor (EGFR) mutation
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a minimum life expectancy of 12 weeks
- Acquired resistance on previous first-line osimertinib. Participants must meet both of the following 2 criteria:
- Radiological documentation of disease progression on first-line osimertinib
- Objective clinical benefit documented during previous osimertinib therapy, defined by either partial or complete radiological response, or durable stable disease (SD) (SD should last greater than (\>) 6 months after initiation of osimertinib
- Have received only first-line osimertinib as a prior line of therapy in the non curative advanced or metastatic NSCLC setting
- MET amplification as determined by either FISH testing (central or local) on tumor tissue (TBx) or central blood-based next generation sequencing (LBx). Tumor and blood samples must be collected following progression on prior first-line osimertinib at Prescreening
- Submission of tumor tissue and blood sample obtained after progression on first-line osimertinib, is mandatory for all patients for MET amplification testing
- Submission of tumor tissue during Prescreening or Screening is mandatory for patients with tumor tissue tested by local FISH, to confirm MET amplification status. Central confirmation is not mandated prior to the start of study treatment
排除标准
- Spinal cord compression or brain metastasis unless asymptomatic, stable or not requiring steroids for at least 2 weeks prior to start of study intervention
- Any unresolved toxicity Grade 2 or more according to National cancer institute common terminology criteria for adverse events( NCI-CTCAE) version 5, from previous anticancer therapy with the exception of alopecia
- Inadequate hematological, liver and renal function
- Impaired cardiac function
- History of interstitial lung disease(ILD) or interstitial pneumonitis including radiation pneumonitis that required steroid treatment
- Hypertension uncontrolled by standard therapies (not stabilized to \< 150/90 millimeter of mercury (mmHg)
- Contraindication to the administration of osimertinib
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。