Furmonertinib Combined With Intrathecal Chemotherapy and Stereotactic Radiotherapy (SRT) for EGFR… (NCT07304739) | Clinical Trial Compass
RecruitingPhase 2
Furmonertinib Combined With Intrathecal Chemotherapy and Stereotactic Radiotherapy (SRT) for EGFR-Mutated NSCLC Patients With Brain Parenchymal and Leptomeningeal Metastases
China30 participantsStarted 2025-12-22
Plain-language 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
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) TBIL ≤1.5 times the upper limit of the normal value, AST and ALT ≤2.5 times the upper limit of the normal value (for those with liver metastasis, total bilirubin ≤ 3 times the upper limit of the normal value, AST and ALT≤ 5 times the upper limit of the normal value are allowed); 3) CrCL ≥50 ml/min (calculated according to the Cockcroft-Gault formula);
* The ECOG score at the time of screening was 0-2, and there was no significant deterioration of the disease within 2 weeks before the screening;
* The expected survival period is greater than 12 weeks;
* Non-pregnant female patients of childbearing potential with no pregnancy plan. Female subjects of childbearing potential and male subjects mu…
What they're measuring
1
iPFS
Timeframe: From enrollment to the occurrence of intracranial disease progression (excluding non-intracranial progression) or death,assessed up to 2 year
Trial details
NCT IDNCT07304739
SponsorTianjin Medical University Cancer Institute and Hospital