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

NCT05514314 | Unknown Phase 2

• 1 other identifier: BD-IC-IV96
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Recurrence-Free Survival (RFS)

  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.

  Up to approximately 10 years

Secondary Outcomes (2)

• Overall Survival (OS)

  Up to approximately 10 years

• Safety and tolerability

  Up to approximately 10 years

Study Arms (1)

Icotinib

EXPERIMENTAL

Icotinib oral 125mg tid for 2 years

Drug: Icotinib

Interventions

Icotinib 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

Icotinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• pathologically confirmed vascular invasion positive;
• pathologically confirmed lung adenocarcinoma containing solid or micropapillary or complex gland histology, with a percentage \> 20%;
• pathologically confirmed invasive tumor size \> 2 cm;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wu Nan: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

icotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: September 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: June 30, 2025
• Last Updated: August 24, 2022

Record last verified: 2022-08