Actively Recruiting
Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations
Led by Betta Pharmaceuticals Co., Ltd. · Updated on 2023-09-22
570
Participants Needed
3
Research Sites
348 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This multicenter, randomized, controlled, double-blind, double-simulated, Phase III study is designed to evaluate the efficacy and safety of Befotertinib compared with Icotinib as adjuvant treatment in EGFR-sensitive mutation-positive stage IB-IIIB (T3N2M0) non-small cell lung cancer after surgical resection.
CONDITIONS
Official Title
Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to sign informed consent and able to follow study visits and procedures
- Male or female aged 18 years or older
- Histologically confirmed non-small cell lung cancer, mainly non-squamous cell carcinoma
- No evidence of brain metastasis
- Complete surgical resection of Stage IB, II, IIIA, or IIIB (T3N2M0) lung cancer with negative margins
- Tumor tested positive for common EGFR mutations Ex19del or L858R
- Fully recovered from surgery with complete wound healing and able to start treatment within 4-10 weeks after surgery
- ECOG performance status 0 or 1 with expected survival over 12 weeks
- Female participants with fertility potential must have a negative pregnancy test
- Participants who can use effective contraception during the study and for 3 months after treatment ends
You will not qualify if you...
- Presence of unresectable or metastatic disease, positive surgical margins, extranodal invasion, or residual lesions after surgery
- Upper lung groove cancer
- Complete resection of the right lung with NSCLC
- Other malignancies within 5 years except certain treated cancers
- Previous systemic anti-tumor therapy before enrollment
- Major surgery within 3 weeks before first dose
- Use of Traditional Chinese medicine with anti-tumor effects within 14 days before first dose
- Need for systemic or local anti-tumor treatment after study starts
- Significant cardiovascular diseases including abnormal ECG, low heart function, uncontrollable hypertension, recent heart failure, arrhythmias needing treatment, severe angina, or recent stroke
- History or presence of interstitial lung disease or drug-induced lung disease
- History or risk of thrombosis
- Serious active infections or diseases affecting drug acceptance
- Significant gastrointestinal disorders affecting drug intake or absorption
- Abnormal lab tests
- Known allergy to befotertinib, icotinib, or their ingredients
- Use of strong CYP3A inhibitors or inducers within 1 week before first dose
- Use of warfarin within 7 days before first dose
- Participation in other clinical trials with investigational drugs within 4 weeks before first dose
- Live vaccination within 180 days before first dose
- Conditions affecting ability to comply with study or provide informed consent such as mental illness, drug abuse, or other significant diseases
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Peking University International Hospital
Beijing, China
Actively Recruiting
2
Jiangsu Cancer Hospital
Nanjing, China
Actively Recruiting
3
Shanghai chest hospital
Shanghai, China
Actively Recruiting
Research Team
S
Shun Lu, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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