Icotinib Following Chemotherapy Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA NSCLC With EGFR Mutation
- Registration Number
- NCT01996098
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
The purpose of this study is studying icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation.
- Detailed Description
Adjuvant chemotherapy is recommended for routine use in patients with fully resected stage IIA-IIIA non-small cell lung cancer (NSCLC). Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced non-small cell lung cancer (NSCLC) with EGFR mutation. Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists. In the phase III ICOGEN trial, icotinib had non-inferiority efficacy to gefitinib with better safety. In phase II trial, chemotherapy followed by 6-month gefitinib as adjuvant therapy can confer longer disease-free survival compared with chemotherapy alone in patients with resected stage IIIA-N2 non-small cell lung cancer harboring EGFR mutations. This study is to studying 6-month or 12-month icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 318
- Written informed consent provided.
- Aged 18-75 years.
- Had completely resected pathological confirmed stage IIA-IIIA NSCLC.
- EGFR activating mutation in exon 19 or 21.
- Had completed four cycles of platinum-based adjuvant chemotherapy.
- Able to start the investigational therapy within 4 weeks after the completion of four cycles of adjuvant chemotherapy.
- ECOG performance status of 0-1.
- Had a life expectancy of 12 weeks or more.
- Adequate hematological function, adequate liver function and renal function.
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- Female patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.
- Had had previous chemotherapy besides four cycles of adjuvant chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 6-month icotinib 6-month Icotinib Icotinib 125 mg three times daily (375 mg per day) by mouth for 6 months 12-month icotinib 12-month icotinib Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months
- Primary Outcome Measures
Name Time Method Disease-Free Survival 5 years after the last patient is randomized Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.
- Secondary Outcome Measures
Name Time Method Number of Participants with Adverse Events 2 years To assess if the addition of icotinib to chemotherapy is safe.
Change from baseline in patient reported Lung Cancer Functional Assessment 2 years Quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire.
Overall Survival 5 years after the last patient is randomized Overall survival was assessed from randomization to death as a result of any cause.
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China