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

NCT ID: NCT05514314

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2025-06-30

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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Icotinib

Icotinib oral 125mg tid for 2 years

Group Type: EXPERIMENTAL

Icotinib

Intervention Type: DRUG

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

Interventions

Icotinib

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wu Nan

OTHER

Sponsor Role: lead

Responsible Party

Wu Nan

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

BD-IC-IV96

Identifier Type: -

Identifier Source: org_study_id