Adenocarcinoma of the Lung, Adenosquamous Cell Lung Cancer, Bronchial Neoplasms, Large Cell Lung Cancer, Lung Neoplasms, Squamous Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer
Conditions
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.
Interventions
DRUGIcotinib
Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year Disease-Free Survival | From randomization to the time of disease recurrence or death as a result of any cause, assessed up to 3 years | 3-year DFS was defined as the percentage of patients who were disease free at 3 years. 3-year DFS were calculated by the Kaplan-Meier method, and the difference in 3-year DFS between groups was compared by the Z test. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Icotinib: Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months. | 63 |
| Observation Group Observation only group. | 65 |
| Total | 128 |
Baseline characteristics
| Characteristic | Intervention Group | Observation Group | Total |
|---|---|---|---|
| Age, Continuous | 56 Years | 57 Years | 56 Years |
| EGFR mutation site Exon 18 G719X | 2 Participants | 1 Participants | 3 Participants |
| EGFR mutation site Exon 19 deletion | 32 Participants | 30 Participants | 62 Participants |
| EGFR mutation site Exon 21 L858R | 29 Participants | 34 Participants | 63 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 63 Participants | 65 Participants | 128 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 37 Participants | 38 Participants | 75 Participants |
| Sex: Female, Male Male | 26 Participants | 27 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 3 / 65 |
| other Total, other adverse events | 49 / 63 | 0 / 65 |
| serious Total, serious adverse events | 4 / 63 | 0 / 65 |
Outcome results
Primary
3-year Disease-Free Survival
3-year DFS was defined as the percentage of patients who were disease free at 3 years. 3-year DFS were calculated by the Kaplan-Meier method, and the difference in 3-year DFS between groups was compared by the Z test.
Time frame: From randomization to the time of disease recurrence or death as a result of any cause, assessed up to 3 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | 3-year Disease-Free Survival | 96.1 Percentage of patients at 3 years |
| Observation Group | 3-year Disease-Free Survival | 84.0 Percentage of patients at 3 years |