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Trial 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

NCT ID: NCT05514314

Condition: Non-Small Cell Lung Cancer

Conditions: Official terms:
Recurrence

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Icotinib
Description: 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
Arm group label: Icotinib

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Start date: September 1, 2022

Completion date: June 30, 2025

Lead sponsor:
Agency: Wu Nan
Agency class: Other

Source: Peking University Cancer Hospital & Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05514314

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