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Icotinib for Completed Resected IB NSCLC With EGFR Mutation (CORIN)

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ClinicalTrials.gov Identifier: NCT02264210
Recruitment Status : Recruiting
First Posted : October 15, 2014
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Si-Yu Wang, Sun Yat-sen University

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
Lung Neoplasms Squamous Cell Lung Cancer Adenocarcinoma of the Lung Adenosquamous Cell Lung Cancer Large Cell Lung Cancer Bronchial Neoplasms Stage IB Non-small Cell Lung Cancer Drug: Icotinib 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2015
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Overall survival [ Time Frame: 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


Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 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

  2. Number of Participants with Adverse Events [ Time Frame: Up to 5 years ]
    The NCI Common Terminology Criteria for Adverse Events version 3.0 will be used



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264210


Contacts
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Contact: Si-Yu Wang, MD +86 20 87343314 wsysums@163.net

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Si-Yu Wang, Doctor    +86 20 87343439    wsysums@163.net   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Si-Yu Wang, MD Guangdong Province Association Study of Thoracic Oncology
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Responsible Party: Si-Yu Wang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02264210    
Other Study ID Numbers: GASTO1003
wsy004 ( Other Identifier: Guangdong Province Association Study of Thoracic Oncology )
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
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Lung Neoplasms
Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma of Lung
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bronchial Diseases