Non-Small Cell Lung Cancer
Conditions
Brief summary
This is a multicenter single arm study, with an aim to assess the effects of adjuvant icotinib among EGFR mutant stage I lung adenocarcinoma patients, who have high-risk pathological features of recurrence.
Interventions
DRUGIcotinib
Within 4-6 weeks after surgery, Icotinib 125mg orally, TID was started for 2 years, or treatment was discontinued due to tumor recurrence or intolerance
Sponsors
Wu Nan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, at least ≥ 18 years，and ≦ 80 years * Lung adenocarcinoma. * Stage I disease(IA or IB), based on TNM8 classification. * There is at least one of the following high-risk factors: 1. pathologically confirmed vascular invasion positive; 2. pathologically confirmed lung adenocarcinoma containing solid or micropapillary or complex gland histology, with a percentage \> 20%; 3. pathologically confirmed invasive tumor size \> 2 cm; 4. pathologically confirmed visceral pleural involvement (T2a). * Started adjuvant therapy in this study 4-6 weeks after complete resection without any previous antitumor therapy. * A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R) ,without KRAS mutation * World Health Organization performance status of 0 or 1. * Bood routine: HB \> 80g/L; ANC \> 1.0x109/L; PLT \> 50x109/L.Blood biochemistry： ALT and AST \< 2.5 times the upper limit of normal; Crea \< 1.5 times the upper limit of normal. * Good adherence to follow-up. * During the trial and for 3 months after the trial，Participants must be using highly effective contraceptive measures.
Exclusion criteria
* Prior treatment with any anticancer therapy for NSCLC (including chemotherapy, radiotherapy, immunotherapy, and EGFR-TKIs). * Local radiotherapy. * Patients with cancers other than NSCLC (except cured cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumors) within 5 years prior to the start of treatment in this study. * Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, angina pectoris beginning within the last 3 months, congestive heart failure, myocardial infarction occurring within 6 months prior to enrollment, severe arrhythmia requiring medication, liver, kidney or metabolic disease). * Any clinical evidence suggestive of active interstitial lung disease. * An eye inflammation or eye infection that is not fully controlled, or any condition that could lead to one of these eye conditions. * Known human immunodeficiency virus (HIV) infection. * Known hypersensitivity to EGFR-TKI drugs or related components. * Mixed small cell and non-small cell cancer history. * Substance abuse, or illnesses such as psychological or psychiatric disorders that may interfere with study compliance. * Patients with epilepsy requiring medication (e.g. steroids or anti-epileptic drugs). * Other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-Free Survival (RFS) | Up to approximately 10 years | RFS is defined as the time from the date of curative resection to the first documented recurrence or death due to any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to approximately 10 years | OS is defined as the time from the date of randomisation until death due to any cause. |
| Safety and tolerability | Up to approximately 10 years | AEs graded by CTCAE version 5.0 |
Outcome results
None listed