Furmonertinib Combined With Intrathecal Chemotherapy and Stereotactic Radiotherapy (SRT) f
A Single-Arm Clinical Study of Furmonertinib (160mg) Combined with Intrathecal Chemotherapy (ITC) and Stereotactic Radiotherapy (SRT) as First-Line Treatment in EGFR Classic Mutation-Positive NSCLC Patients with Brain Parenchymal and Leptomeningeal Metastases
| Condition(s) | Non Small Cell Lung Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | A Single-Arm Clinical Study of Furmonertinib (160mg) Combined with Intrathecal Chemotherapy (ITC) and Stereotactic Radiotherapy (SRT) as First-Line Treatment in EGFR Classic Mutation-Positive NSCLC Patients with Brain Parenchymal and Leptomeningeal Metastases |
| Who can participate | Inclusion Criteria: * 18 to 75 years old, male or female; * Histopathologically confirmed, unresectable, and not amenable to curative radiotherapy treatment-naïve locally advanced or metastatic lung adenocarcinoma; * The patient was confirmed by a local laboratory to have one of the following EGFR mutations :19Del or L858R; * The patient has not received any systemic anti-tumor treatment in the locally advanced (the researcher judged that it was not suitable for surgery or radiotherapy) or metastatic NSCLC; * At least one measurable tumor lesion (according to RECIST1.1); * Confirm the simultaneous presence of brain parenchymal and meningeal metastasis; * Laboratory tests indicated that the subjects had adequate organ functions, including: 1) ANC ≥1.5×109/L; PLT ≥100×109/L; HGB ≥90g/L; 2) T |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Locations | Cangzhou, Hebei, China; Tianjin, Tianjin Municipality, China; Tianjin, Tianjin Municipality, China |
| Start date | 2025-12-22 |
| NCT ID | NCT07304739 |
| Official listing | https://clinicaltrials.gov/study/NCT07304739 |