Clinical trial NCT02264210: Icotinib for Completed Resected IB NSCLC With EGFR Mutation
Official title: A Randomized, Phase II Trial of Icotinib Versus Observation as Adjuvant Treatment in Stage IB Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Neoplasms
Squamous Cell Lung Cancer
Adenocarcinoma of the Lung
Adenosquamous Cell Lung Cancer
Large Cell Lung Cancer
Bronchial Neoplasms
Stage IB Non-small Cell Lung Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-10-15
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 kinase inhibitors (EGFR-TKIs) show great efficacy in patients with EGFR mutant non-small cell lung cancer (NSCLC). Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. In the phase III ICOGEN trial, icotinib had non-inferiority efficacy to gefitinib with better safety. This study is studying icotinib to see how well it works in treating patients with fully resected stage IB NSCLC harboring EGFR mutation.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: 3-year Disease-Free Survival
timeFrame: From randomization to the time of disease recurrence or death as a result of any cause, assessed up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Guangdong Province Association Study of Thoracic Oncology
name: Si-Yu Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: