Actively Recruiting
Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer
Led by Peking Union Medical College Hospital · Updated on 2023-02-16
114
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single arm study to investigate the efficacy and safety furmonertinib 80mg/d as adjuvant treatment for 3 years post surgery of stage IA with high-risk factors and stage IB non-small cell lung cancer. A total of 114 patients would be enrolled. The primary endpoint is the disease-free survival rate at 3 years.
CONDITIONS
Official Title
Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Received radical surgery to remove non-small cell lung cancer without prior anti-tumor treatments
- Diagnosed with non-small cell lung cancer by at least 2 pathologists
- Stage IA with high-risk factors or stage IB disease according to the 8th AJCC lung cancer staging
- Positive for EGFR mutation by tissue-based NGS testing
- ECOG performance status of 0 or 1
- Adequate liver, kidney, and blood function
- Signed informed consent and able to report side effects and follow study rules
You will not qualify if you...
- Lung cancer with small cell or neuroendocrine cancer cells
- Positive for EGFR exon 20 insertion mutation
- Presence of other driver mutations such as ALK, ROS1, or MET
- Pregnant or breastfeeding women
- Use of strong CYP3A4 inhibitors or inducers shortly before starting study drug
- Received other anti-tumor treatments including traditional Chinese medicine within 14 days before enrollment
- Other active cancers except carcinoma in situ
- Uncontrolled serious diseases including heart conditions, infections like HBV, HCV, or HIV
- Gastrointestinal problems affecting drug absorption
- History or risk factors for QT prolongation
- History of interstitial lung disease
- Allergy to any component of furmonertinib
- Mental illness or drug abuse
- Received live vaccine within 30 days before enrollment
- Participation in another investigational drug study or use of study drugs/devices within 4 weeks before enrollment
- Any other condition the investigator considers unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hopital
Beijing, China
Actively Recruiting
Research Team
R
Ruixuan Geng, 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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