Icotinib Following Chemotherapy Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA NSCLC With EGFR Mutation
Lung Cancer
Study Type
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: 6-month Icotinib Type: Drug
Name: 12-month icotinib Type: Drug
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Si-Yu Wang, MD - +86 20 87343439 - wsysums@163.net
Start Date
January 2014
Completion Date
January 2021
Sun Yat-sen University
Sun Yat-sen University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page