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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