Icotinib for Completed Resected IB NSCLC With EGFR Mutation
CORIN
A Randomized, Phase II Trial of Icotinib Versus Observation as Adjuvant Treatment in Stage IB Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutation
2 other identifiers
interventional
128
1 country
1
Brief Summary
This phase II trial studies how well icotinib works in treating patients with completely resected stage IB NSCLC harboring EGFR mutation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2015
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2014
CompletedFirst Posted
Study publicly available on registry
October 15, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedResults Posted
Study results publicly available
September 25, 2024
CompletedSeptember 25, 2024
September 1, 2024
5.9 years
October 8, 2014
January 18, 2024
September 19, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
3-year Disease-Free Survival
3-year DFS was defined as the percentage of patients who were disease free at 3 years. 3-year DFS were calculated by the Kaplan-Meier method, and the difference in 3-year DFS between groups was compared by the Z test.
From randomization to the time of disease recurrence or death as a result of any cause, assessed up to 3 years
Study Arms (2)
Intervention group
EXPERIMENTALIcotinib 125 mg three times daily (375 mg per day) orally for 12 months.
Observation group
NO INTERVENTIONObservation.
Interventions
Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months.
Eligibility Criteria
You may qualify if:
- Written informed consent provided.
- Males or females, Aged 18-75 years.
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- Had completely resected pathological confirmed stage IIA-IIIA NSCLC.
- EGFR activating mutation in exon 19 or 21.
- Patient who can start the investigational therapy within 3-6 weeks after the complete resection.
- ECOG performance status of 0-1.
- Had a life expectancy of 12 weeks or more.
- Adequate hematological function, adequate liver function and renal function.
- Female patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.
You may not qualify if:
- Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- Inability to comply with protocol or study procedures.
- Had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder.
- Any evidence confirmed tumor recurrence before investigational therapy.
- Known severe hypersensitivity to icotinib or any of the excipients of this product.
- Evidence of clinically active interstitial lung disease.
- Eye inflammation not fully controlled or conditions predisposing the subject to this.
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Known human immunodeficiency virus (HIV) infection.
- Pregnancy or breast-feeding women.
- Ingredients mixed with small cell lung cancer patients.
- History of neurologic or psychiatric disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Related Publications (1)
Ou W, Li N, Wang BX, Zhu TF, Shen ZL, Wang T, Chang WG, Chang ZH, Hu XX, Pu Y, Ding LM, Wang SY. Adjuvant icotinib versus observation in patients with completely resected EGFR-mutated stage IB NSCLC (GASTO1003, CORIN): a randomised, open-label, phase 2 trial. EClinicalMedicine. 2023 Feb 3;57:101839. doi: 10.1016/j.eclinm.2023.101839. eCollection 2023 Mar.
PMID: 36816343DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Si-Yu Wang
- Organization
- Sun Yat-sen University Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Si-Yu Wang, MD
Guangdong Province Association Study of Thoracic Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 8, 2014
First Posted
October 15, 2014
Study Start
January 1, 2015
Primary Completion
December 1, 2020
Study Completion
July 1, 2022
Last Updated
September 25, 2024
Results First Posted
September 25, 2024
Record last verified: 2024-09