Actively Recruiting
High-dose Furmonertinib for First-line Treatment of EGFR Mutated NSCLC With Central Nervous System (CNS) Metastases
Led by Hunan Province Tumor Hospital · Updated on 2024-09-19
40
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
EGFR mutated NSCLC patiens with CNS metastases have poor prognosis. High-dose furmonertinib (160mg/day) have produced high CNS PFS and ORR in second-line for EGFR T790M mutated NSCLC. Whether EGFR mutated NSCLC with CNS metastases can benefit from first-line treatment of high-dose furmonertinib has not been reported. This study aims to investigate the efficacy and safety of high dose furmonertinib in first-line treatment of EGFR mutated NSCLC patiens.
CONDITIONS
Official Title
High-dose Furmonertinib for First-line Treatment of EGFR Mutated NSCLC With Central Nervous System (CNS) Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any study-related procedure.
- Age 18 years or older.
- ECOG performance status of 0 to 1 with no significant decline in the prior 2 weeks.
- Expected survival of at least 12 weeks.
- Histologically or cytologically confirmed metastatic NSCLC with EGFR 19del or exon 21del L858R mutation.
- At least one measurable CNS metastatic lesion without prior radiotherapy or biopsy.
- No prior treatment for advanced/metastatic NSCLC, except allowed adjuvant or neoadjuvant therapy without progression within 6 months.
- Negative pregnancy test for premenopausal women with childbearing potential.
- Not lactating and willing to use contraception.
- Agree to follow study treatment and follow-up plans, able to take oral medicine.
You will not qualify if you...
- Small cell lung carcinoma diagnosis.
- History of hypersensitivity to study drug or similar compounds.
- Confirmed EGFR exon 20 insertion mutation.
- Prior treatment with any EGFR tyrosine kinase inhibitors.
- Intrapleural perfusion therapy within 28 days before enrollment unless pleural effusion is stable.
- Major surgery within 4 weeks before first dose.
- Radiotherapy to over 30% of bone marrow or wide-field radiation within 4 weeks before first dose.
- Use of strong CYP3A4 inhibitors or inducers within 7 days before the first dose or during the study.
- Use of traditional Chinese medicine with anti-tumor indications within 7 days before the first dose or during the study.
- Use of drugs that prolong QTc interval or cause torsade de pointe during the study.
- Treatment with other investigational drugs within 5 half-lives or 14 days before first dose.
- Prior systemic anti-cancer therapy for advanced NSCLC except certain adjuvant/neoadjuvant therapy.
- Unresolved toxicities from prior treatments exceeding specified severities.
- Spinal cord compression or unstable symptomatic brain metastases.
- Other malignant tumors in past 5 years except certain controlled types.
- Severe nausea, vomiting, gastrointestinal disease, or conditions precluding drug absorption.
- Severe or uncontrolled systemic diseases making participation undesirable.
- History or evidence of interstitial lung disease or related lung conditions.
- Corneal injury.
- Inadequate bone marrow or organ function.
- QT prolongation or serious heart rhythm abnormalities.
- Poor compliance judged by investigators.
- Pregnancy or lactation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hunan Cancer hospital
Changsha, Hunan, China
Actively Recruiting
Research Team
N
Nong C Yang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here