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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05514314
• Other study ID #: BD-IC-IV96
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2022
• Source: Peking University Cancer Hospital & Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Non-Small Cell Lung Cancer
• Recurrence

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wu Nan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival (OS)	OS is defined as the time from the date of randomisation until death due to any cause.	Up to approximately 10 years
Secondary	Safety and tolerability	AEs graded by CTCAE version 5.0	Up to approximately 10 years