Status:
COMPLETED
Icotinib for Completed Resected IB NSCLC With EGFR Mutation
Lead Sponsor:
Sun Yat-sen University
Conditions:
Lung Neoplasms
Squamous Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well icotinib works in treating patients with completely resected stage IB NSCLC harboring EGFR mutation.
Detailed Description
Adjuvant chemotherapy have shown little evidence of survival benefit in patients with stages IB non-small cell lung cancer (NSCLC) after complete resection. Epidermal growth factor receptor tyrosine k...
Eligibility Criteria
Inclusion
- Written informed consent provided.
- Males or females, Aged 18-75 years.
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- Had completely resected pathological confirmed stage IIA-IIIA NSCLC.
- EGFR activating mutation in exon 19 or 21.
- Patient who can start the investigational therapy within 3-6 weeks after the complete resection.
- ECOG performance status of 0-1.
- Had a life expectancy of 12 weeks or more.
- Adequate hematological function, adequate liver function and renal function.
- Female patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.
Exclusion
- Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- Inability to comply with protocol or study procedures.
- Had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder.
- Any evidence confirmed tumor recurrence before investigational therapy.
- Known severe hypersensitivity to icotinib or any of the excipients of this product.
- Evidence of clinically active interstitial lung disease.
- Eye inflammation not fully controlled or conditions predisposing the subject to this.
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Known human immunodeficiency virus (HIV) infection.
- Pregnancy or breast-feeding women.
- Ingredients mixed with small cell lung cancer patients.
- History of neurologic or psychiatric disorders.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT02264210
Start Date
January 1 2015
End Date
July 1 2022
Last Update
September 25 2024
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060