Actively Recruiting
Furmonertinib Combined With Intrathecal Chemotherapy and Stereotactic Radiotherapy (SRT) for EGFR-Mutated NSCLC Patients With Brain Parenchymal and Leptomeningeal Metastases
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-12-26
30
Participants Needed
3
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Furmonertinib Combined With Intrathecal Chemotherapy and Stereotactic Radiotherapy (SRT) for EGFR-Mutated NSCLC Patients With Brain Parenchymal and Leptomeningeal Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Confirmed, unresectable, locally advanced or metastatic lung adenocarcinoma
- Confirmed EGFR mutation: 19Del or L858R
- No prior systemic anti-tumor treatment for advanced or metastatic NSCLC
- At least one measurable tumor lesion by RECIST1.1
- Presence of both brain parenchymal and leptomeningeal metastases
- Adequate organ function based on laboratory tests
- ECOG score 0-2 without significant disease worsening in past 2 weeks
- Expected survival over 12 weeks
- Non-pregnant females of childbearing potential with no pregnancy plan and agreement to use contraception during and 6 months post-study
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- NSCLC dominated by squamous cells or presence of small cell lung cancer or neuroendocrine carcinoma
- Presence of other driver gene mutations except TP53, RB1, BRAC
- Need for other antitumor therapies beyond this trial during study
- Major surgery within 4 weeks before or during the trial (excluding minor procedures)
- Use of strong CYP3A4 inhibitors within 7 days or inducers within 21 days before first dose
- Use of Chinese herbal anti-tumor medicines within 2 weeks before first dose or during trial
- Participation in another investigational drug or device trial within 4 weeks or 5 half-lives before first dose
- Antitumor drug treatment within 14 days before first dose
- Symptomatic or unstable pleural or peritoneal effusion
- Unrecovered toxicities from prior therapy above grade 1, except alopecia or residual neurotoxicity from platinum therapy
- History or current other malignancies except those treated with no recurrence for 5 years
- History or signs of interstitial lung disease or radiation pneumonitis requiring steroids
- Severe or uncontrolled systemic diseases including certain heart, infectious, and gastrointestinal conditions
- Resting QT interval >470 msec or significant arrhythmias
- Active psychiatric disorders or drug abuse
- Hypersensitivity to Furmonertinib or its components
- Pregnancy or breastfeeding, or partner plans for pregnancy during study
- Poor compliance or other conditions making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
CANGZHOU People's Hospital
Cangzhou, Hebei, China, 061001
Actively Recruiting
2
Tianjin medical university cancer hospital and institute
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
3
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China, 300350
Actively Recruiting
Research Team
M
Maobin Meng, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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