Actively Recruiting
Evaluating High-dose Furmonertinib with Bevacizumab and Pemetrexed for EGFRm NSCLC with Leptomeningeal Metastasis
Led by Henan Cancer Hospital · Updated on 2025-03-06
60
Participants Needed
2
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this clinical study is to evaluate the efficacy of high-dose furmonertinib combined with bevacizumab and pemetrexed (triple therapy) in the treatment of non-small cell lung cancer (NSCLC) with leptomeningeal metastasis and epidermal growth factor receptor mutation (EGFRm) through overall survival (OS). The secondary objectives are to further assess the efficacy of the triple therapy in patients with EGFRm and leptomeningeal metastasis, including time to treatment failure (TTF), leptomeningeal objective response rate (ORR-LM), and clinical response rate.The study will also evaluate the impact of the triple therapy on quality of life using the EORTC QLQ-C30 scale and assess the safety of the therapy in EGFRm NSCLC patients with leptomeningeal metastasis, focusing primarily on adverse events and their severity (graded according to CTCAE v5.0), as well as their frequency.The exploratory objectives are to assess changes in intracranial pressure and the improvement rate of cerebrospinal fluid (CSF) before and after the triple therapy treatment. Additionally, the study will compare the genomic and epigenomic profile changes in circulating tumor DNA (ctDNA) from peripheral blood and cell-free DNA (cfDNA) from cerebrospinal fluid before and after treatment, and analyze their correlation with clinical outcomes, drug efficacy, and other clinical indicators. The primary endpoint of this study is overall survival (OS). The secondary endpoints include time to treatment failure (TTF), leptomeningeal objective response rate (ORR-LM), clinical response rate, and quality of life assessment (EORTC QLQ-C30).The safety endpoints are adverse events and their severity (graded according to CTCAE v5.0), as well as the frequency of occurrence. A total of 60 patients are planned to be enrolled, targeting eligible advanced NSCLC patients with EGFR mutations and leptomeningeal metastasis. The intervention consists of furmonertinib (240 mg/d, po) combined with bevacizumab (15 mg/kg, every 3 weeks, ivgtt) and pemetrexed (50 mg) intrathecal chemotherapy / pemetrexed (500 mg/m²) intravenous chemotherapy, administered every 3 weeks.
CONDITIONS
Official Title
Evaluating High-dose Furmonertinib with Bevacizumab and Pemetrexed for EGFRm NSCLC with Leptomeningeal Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained from the patient or legal representative
- Age 18 years or older, any gender
- Diagnosis of non-small cell lung cancer confirmed by pathology
- Positive for classical or non-classical EGFR mutations by genetic testing
- Definite leptomeningeal metastasis confirmed by clinical evaluation, imaging, and/or cerebrospinal fluid pathology
- Includes newly diagnosed leptomeningeal metastases and those with progression after prior therapy
- ECOG Performance Status between 0 and 3
- Prior radiation or surgery targeting the central nervous system allowed
- Patients may have CNS symptoms or signs that are not life threatening
- Fertile patients must use effective contraception during the trial and for 12 months after treatment ends
You will not qualify if you...
- Presence of tumors other than NSCLC
- History of other malignancies within last 5 years except controlled basal cell carcinoma of skin, carcinoma in situ of cervix, and ductal carcinoma in situ of breast
- Serious digestive diseases affecting drug use or absorption (e.g., peptic ulcer, inflammatory bowel disease)
- Severe or uncontrolled systemic diseases including uncontrolled hypertension, diabetes, active bleeding, or active infections like hepatitis B/C or HIV
- History or evidence of interstitial lung disease or radiation pneumonia requiring steroids
- Significant arrhythmias (e.g., prolonged QT interval > 500ms) or heart failure (left ventricular ejection fraction < 50%)
- Pregnant or breastfeeding women
- Receipt of live vaccine within 4 weeks before treatment
- Participation in another clinical trial within 4 weeks
- Other severe medical or psychiatric conditions or lab abnormalities that increase risk or interfere with study participation or interpretation
- Subjects unable to complete or comply with study requirements for any reason
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Actively Recruiting
2
Henan Cancer Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
Research Team
Q
Qi Zhao, MS
CONTACT
H
Haiyang Chen, 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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