Back to resultsA Multicenter Prospective Study to Assess the Effects of Adjuvant Icotinib in EGFRm Stage I NSCLC With High-risk of Disease Recurrence After Complete Resection
Primary Purpose
Non-Small Cell Lung Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Icotinib
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
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:
- 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.
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Icotinib
Arm Description
Icotinib oral 125mg tid for 2 years
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall Survival (OS)
OS is defined as the time from the date of randomisation until death due to any cause.
Safety and tolerability
AEs graded by CTCAE version 5.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05514314
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wu Nan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Icotinib
Arm Type
Experimental
Arm Description
Icotinib oral 125mg tid for 2 years
Intervention Type
Drug
Intervention Name(s)
Icotinib
Intervention 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
Primary Outcome Measure Information:
Title
Recurrence-Free Survival (RFS)
Description
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.
Time Frame
Up to approximately 10 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomisation until death due to any cause.
Time Frame
Up to approximately 10 years
Title
Safety and tolerability
Description
AEs graded by CTCAE version 5.0
Time Frame
Up to approximately 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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:
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.
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.
12. IPD Sharing Statement
Learn more about this trial
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
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