Actively Recruiting
Befotertinib and Icotinib for NSCLC With Uncommon EGFR Mutations
Led by Sun Yat-sen University · Updated on 2024-07-25
23
Participants Needed
1
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research study aims to explore the combination of two targeted drugs as first-line treatment for Non-Small Cell Lung Cancer (NSCLC) with uncommon EGFR mutation.
CONDITIONS
Official Title
Befotertinib and Icotinib for NSCLC With Uncommon EGFR Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Pathologically confirmed lung adenocarcinoma with locally advanced or metastatic disease (stage IIIB, IIIC, or IV) not suitable for curative surgery or radiotherapy
- Treatment-naive for systemic antitumor therapy for locally advanced or metastatic NSCLC; prior adjuvant or neoadjuvant therapy allowed if completed at least 6 months before disease progression
- Confirmed rare EGFR mutations including exon 18 G719X, exon 20 S768I, or exon 21 L861Q
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Predicted survival of 3 months or more
- At least one measurable tumor lesion without prior radiotherapy as per RECIST v1.1
- Agreement to use effective contraception during the study and for at least 3 months after treatment
- Provision of informed consent before any study procedures
You will not qualify if you...
- Presence of other malignancies except clinically cured in situ cervix carcinoma, basal cell or squamous epithelial skin cancer, or thyroid papillary carcinoma
- Prior treatment with any EGFR-TKIs
- Prior systemic antitumor therapy for locally advanced or metastatic NSCLC
- Use of traditional Chinese medicine with antitumor indication within 2 weeks before first study drug dose
- Major surgery within 4 weeks before first study drug dose or planned major surgery during study
- Symptoms or signs worsened within 2 weeks before first study drug dose
- Unresolved toxicities from prior treatment greater than grade 2 (NCI CTCAE v4.03)
- Symptomatic or unstable central nervous system metastases requiring steroids; stable CNS status allowed if stable for at least 4 weeks
- Serious or uncontrolled systemic diseases including uncontrolled hypertension after treatment, active bleeding disorders, thrombus, uncontrolled cardiovascular or cerebrovascular diseases
- Active infections including hepatitis B, hepatitis C, syphilis, or HIV
- Prolonged QT interval or significant ECG abnormalities, or left ventricular ejection fraction ≤50%
- History or clinical evidence of interstitial lung disease or drug-induced lung toxicity
- Conditions affecting ability to swallow drugs or causing oral malabsorption
- Laboratory abnormalities including: absolute neutrophil count <1500/mcL, platelets <100,000/mcL, hemoglobin <9.0 g/dL, elevated liver enzymes or bilirubin beyond specified limits, serum creatinine >1.5 times upper limit of normal or creatinine clearance ≤50 mL/min
- Known allergy or hypersensitivity to study drugs or their components
- Use of potent inhibitors or inducers of CYP enzymes within 1 week before first study drug dose
- Use of warfarin within 1 week before first study drug dose
- Participation in another therapeutic clinical trial within 4 weeks before first study drug dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
X
Xue Hou, 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