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CORIN: Icotinib for Completed Resected IB NSCLC With EGFR Mutation

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02264210
Collaborator
(none)
128
Enrollment
1
Location
2
Arms
131
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase II trial studies how well icotinib works in treating patients with completely resected stage IB NSCLC harboring EGFR mutation.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Adjuvant chemotherapy have shown little evidence of survival benefit in patients with stages IB non-small cell lung cancer (NSCLC) after complete resection. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with EGFR mutant non-small cell lung cancer (NSCLC). Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. In the phase III ICOGEN trial, icotinib had non-inferiority efficacy to gefitinib with better safety. This study is studying icotinib to see how well it works in treating patients with fully resected stage IB NSCLC harboring EGFR mutation.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jan 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

Icotinib 125 mg three times daily (375 mg per day) orally for 12 months.

Drug: Icotinib
Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months.
Other Names:
  • BPI-2009
  • Conmana

    		•
    No Intervention: Observation group

    Observation.

    Outcome Measures

    Primary Outcome Measures

    1. Disease-free survival [From randomization to the time of disease recurrence or death as a result of any cause, assessed up to 5 years]

      DFS will be estimated by the method of Kaplan-Meier

    Secondary Outcome Measures

    1. Overall survival [From randomization to the time of death as a result of any cause, assessed up to 5 years]

      OS will be estimated by the method of Kaplan-Meier

    2. Number of Participants with Adverse Events [Up to 5 years]

      The NCI Common Terminology Criteria for Adverse Events version 3.0 will be used

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen University Cancer Center Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    • Principal Investigator: Si-Yu Wang, MD, Guangdong Province Association Study of Thoracic Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Si-Yu Wang, Professor, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT02264210
    Other Study ID Numbers:
    • GASTO1003
    • wsy004
    First Posted:
    Oct 15, 2014
    Last Update Posted:
    Aug 3, 2021
    Last Verified:
    Jul 1, 2021
    Additional relevant MeSH terms:
    Lung Neoplasms
    Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Adenocarcinoma of Lung
    Bronchial Neoplasms

    Study Results

    No Results Posted as of Aug 3, 2021