Clinical Trials /

Icotinib for Completed Resected IB NSCLC With EGFR Mutation

NCT02264210

Description:

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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Icotinib for Completed Resected IB NSCLC With EGFR Mutation
  • 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

Clinical Trial IDs

  • ORG STUDY ID: GASTO1003
  • SECONDARY ID: wsy004
  • NCT ID: NCT02264210

Conditions

  • 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

Interventions

DrugSynonymsArms
IcotinibBPI-2009, ConmanaIntervention group

Purpose

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

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.
    

Trial Arms

NameTypeDescriptionInterventions
Intervention groupExperimentalIcotinib 125 mg three times daily (375 mg per day) orally for 12 months.
  • Icotinib
Observation groupNo InterventionObservation.

    Eligibility 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.
          
    Maximum Eligible Age:75 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Overall survival
    Time Frame:From randomization to the time of death as a result of any cause, assessed up to 5 years
    Safety Issue:
    Description:OS will be estimated by the method of Kaplan-Meier

    Secondary Outcome Measures

    Measure: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
    Safety Issue:
    Description:DFS will be estimated by the method of Kaplan-Meier
    Measure:Number of Participants with Adverse Events
    Time Frame:Up to 5 years
    Safety Issue:
    Description:The NCI Common Terminology Criteria for Adverse Events version 3.0 will be used

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Sun Yat-sen University

    Last Updated

    October 9, 2017