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
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Icotinib Icotinib oral 125mg tid for 2 years |
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
|
Outcome Measures
Primary Outcome Measures
- Recurrence-Free Survival (RFS) [Up to approximately 10 years]
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.
Secondary Outcome Measures
- Overall Survival (OS) [Up to approximately 10 years]
OS is defined as the time from the date of randomisation until death due to any cause.
- Safety and tolerability [Up to approximately 10 years]
AEs graded by CTCAE version 5.0
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female, at least ≥ 18 years，and ≦ 80 years
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Lung adenocarcinoma.
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Stage I disease(IA or IB), based on TNM8 classification.
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There is at least one of the following high-risk factors:
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pathologically confirmed vascular invasion positive;
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pathologically confirmed lung adenocarcinoma containing solid or micropapillary or complex gland histology, with a percentage > 20%;
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pathologically confirmed invasive tumor size > 2 cm;
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pathologically confirmed visceral pleural involvement (T2a).
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Started adjuvant therapy in this study 4-6 weeks after complete resection without any previous antitumor therapy.
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A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R) ,without KRAS mutation
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World Health Organization performance status of 0 or 1.
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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.
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Good adherence to follow-up.
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During the trial and for 3 months after the trial，Participants must be using highly effective contraceptive measures.
Exclusion Criteria:
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Prior treatment with any anticancer therapy for NSCLC (including chemotherapy, radiotherapy, immunotherapy, and EGFR-TKIs).
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Local radiotherapy.
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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.
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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).
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Any clinical evidence suggestive of active interstitial lung disease.
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An eye inflammation or eye infection that is not fully controlled, or any condition that could lead to one of these eye conditions.
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Known human immunodeficiency virus (HIV) infection.
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Known hypersensitivity to EGFR-TKI drugs or related components.
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Mixed small cell and non-small cell cancer history.
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Substance abuse, or illnesses such as psychological or psychiatric disorders that may interfere with study compliance.
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Patients with epilepsy requiring medication (e.g. steroids or anti-epileptic drugs).
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Other conditions deemed unsuitable for enrollment by the investigator.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Wu Nan
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BD-IC-IV96