Clinical trial · Interventional
Icotinib for Completed Resected IB NSCLC With EGFR Mutation
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
NCT02264210CI-TRIAL-00081012CORINcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial studies how well icotinib works in treating patients with completely resected stage IB NSCLC harboring EGFR mutation.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Lung | Lung Adenocarcinoma | ALIAS | 0.90 |
| Adenosquamous Cell Lung Cancer | — | UNRESOLVED | — |
| Bronchial Neoplasms | — | UNRESOLVED | — |
| Large Cell Lung Cancer | Lung Large Cell Carcinoma | ALIAS | 0.90 |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Lung Cancer | Lung Squamous Cell Carcinoma | ALIAS | 0.90 |
| Stage IB Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Icotinib | Drug | Icotinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- Icotinib 125 mg three times daily (375 mg per day) orally for 12 months.
- interventionNames
- Drug: Icotinib
- type
- NO_INTERVENTION
- label
- Observation group
- description
- Observation.
Primary outcomes (1)
- measure
- 3-year Disease-Free Survival
- timeFrame
- From randomization to the time of disease recurrence or death as a result of any cause, assessed up to 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (1)
- DERIVEDOu 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 36816343