A Multicenter Prospective Study to Assess the Effects of Adjuvant Icotinib in EGFRm Stage I NSCLC With High-risk of Disease Recurrence After Complete Resection

Wu Nan

Status and phase

Not yet enrolling

Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Icotinib

Study type

Interventional

Funder types

Other

Identifiers

NCT05514314

BD-IC-IV96

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.