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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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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 must agree to use effective contraception during the study period and for 6 months after discontinuation of the study drug;

• Understand and voluntarily participate in this study and sign the informed consent form.

Locations
Other Locations
China
CANGZHOU People's Hospital
RECRUITING
Cangzhou
Tianjin Huanhu Hospital
RECRUITING
Tianjin
Tianjin medical university cancer hospital and institute
RECRUITING
Tianjin
Contact Information
Primary
Maobin Meng, MD
mmeng@tmu.edu.cn
+86 15202231270
Time Frame
Start Date: 2025-12-22
Estimated Completion Date: 2029-12-30
Participants
Target number of participants: 30
Treatments
Experimental: Furmonertinib combined with intrathecal chemotherapy and stereotactic radiotherapy group
Sponsors
Leads: Tianjin Medical University Cancer Institute and Hospital

This content was sourced from clinicaltrials.gov