Actively Recruiting
Evaluating High-dose Furmonertinib with Bevacizumab and Pemetrexed for EGFR-mutated NSCLC with Leptomeningeal Metastasis in Advanced Patients
Led by Henan Cancer Hospital · Updated on 2025-03-06
60
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a combination treatment using high-dose furmonertinib with bevacizumab and pemetrexed for patients with advanced non-small cell lung cancer (NSCLC) that has spread to the leptomeninges and has mutations in the epidermal growth factor receptor (EGFR). This study aims to measure overall survival while also assessing treatment failure time, response rates of leptomeningeal lesions, clinical response, quality of life, and safety. The study also explores changes in intracranial pressure and genomic profiles before and after treatment. The intervention involves giving patients furmonertinib orally at 240 mg per day, bevacizumab intravenously at 15 mg/kg every three weeks, and pemetrexed either as 50 mg intrathecal chemotherapy or 500 mg/m² intravenous chemotherapy every three weeks. This triple therapy is designed to improve drug penetration into the central nervous system and target leptomeningeal metastases effectively. Patients may have newly diagnosed leptomeningeal metastases or disease progression after prior therapies. Participants will be monitored through symptom evaluations, imaging tests, cerebrospinal fluid pathology, and genetic testing. Researchers will track overall survival, time to treatment failure, response rates, quality of life using the EORTC QLQ-C30 scale, and adverse events graded by CTCAE v5.0. The study plans to enroll 60 patients and will also analyze changes in circulating tumor DNA and cerebrospinal fluid DNA to understand treatment impacts better. Safety and tolerability will be closely observed throughout the study period.
CONDITIONS
Brief 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...
- Provide written informed consent
- Age 18 years or older, any gender
- Confirmed diagnosis of non-small cell lung cancer by pathology
- Positive test for classical or non-classical EGFR mutations
- Confirmed leptomeningeal metastasis by clinical evaluation, imaging, or cerebrospinal fluid pathology
- Newly diagnosed leptomeningeal metastasis or progression after previous cancer therapy
- ECOG performance status between 0 and 3
- Prior radiation or surgery targeting the central nervous system allowed
- CNS symptoms or signs allowed if not life-threatening
- Use of effective contraception during the study and for 12 months after treatment if fertile
You will not qualify if you...
- Presence of tumors other than non-small cell lung cancer
- History of other cancers within the last 5 years except certain controlled skin or cervical/breast cancers
- Serious digestive diseases affecting drug absorption
- Severe or uncontrolled systemic diseases including hypertension, diabetes, active bleeding, or infections such as hepatitis B, C, or HIV
- History or evidence of interstitial lung disease or radiation pneumonia requiring steroids
- Significant heart arrhythmias or heart failure with low ejection fraction
- Pregnant or breastfeeding women
- Received live vaccines within 4 weeks before treatment
- Participation in another clinical study within 4 weeks
- Other severe medical, psychiatric, or laboratory conditions that increase risk or interfere with study participation
- Inability to complete or comply with study requirements for administrative or other reasons
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated every 3 weeks until treatment failure or discontinuation
Participants receive high-dose furmonertinib combined with bevacizumab and pemetrexed chemotherapy to treat EGFR-mutated NSCLC with leptomeningeal metastasis.
Visits every 3 weeks for drug administration and monitoring
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
H
Haiyang Chen, MD
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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