Clinical Trials /

Icotinib Following Chemotherapy Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA NSCLC With EGFR Mutation

NCT01996098

Description:

The purpose of this study is studying icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation.

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

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Icotinib Following Chemotherapy Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA NSCLC With EGFR Mutation
  • Official Title: A Multicenter, Randomized, Phase III Trial of Chemotherapy Followed by 6-month or 12-month Icotinib Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA Non-small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutation

Clinical Trial IDs

  • ORG STUDY ID: GASTO1002
  • SECONDARY ID: wsy003
  • NCT ID: NCT01996098

Conditions

  • Lung Cancer

Interventions

DrugSynonymsArms
6-month IcotinibBPI-2009, Conmana6-month icotinib
12-month icotinibBPI-2009, Conmana12-month icotinib

Purpose

The purpose of this study is studying icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation.

Detailed Description

      Adjuvant chemotherapy is recommended for routine use in patients with fully resected stage
      IIA-IIIA non-small cell lung cancer (NSCLC). Epidermal growth factor receptor tyrosine kinase
      inhibitors (EGFR-TKIs) show great efficacy in patients with advanced non-small cell lung
      cancer (NSCLC) with EGFR mutation. Icotinib is a novel EGFR-TKI developed by a group of
      Chinese scientists. In the phase III ICOGEN trial, icotinib had non-inferiority efficacy to
      gefitinib with better safety. In phase II trial, chemotherapy followed by 6-month gefitinib
      as adjuvant therapy can confer longer disease-free survival compared with chemotherapy alone
      in patients with resected stage IIIA-N2 non-small cell lung cancer harboring EGFR mutations.
      This study is to studying 6-month or 12-month icotinib following chemotherapy to see how well
      it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC
      harboring EGFR mutation.
    

Trial Arms

NameTypeDescriptionInterventions
6-month icotinibExperimentalIcotinib 125 mg three times daily (375 mg per day) by mouth for 6 months
  • 6-month Icotinib
12-month icotinibExperimentalIcotinib 125 mg three times daily (375 mg per day) by mouth for 12 months
  • 12-month icotinib
Chemotherapy aloneNo InterventionNo intervention

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Written informed consent provided.
    
              -  Aged 18-75 years.
    
              -  Had completely resected pathological confirmed stage IIA-IIIA NSCLC.
    
              -  EGFR activating mutation in exon 19 or 21.
    
              -  Had completed four cycles of platinum-based adjuvant chemotherapy.
    
              -  Able to start the investigational therapy within 4 weeks after the completion of four
                 cycles of adjuvant chemotherapy.
    
              -  ECOG performance status of 0-1.
    
              -  Had a life expectancy of 12 weeks or more.
    
              -  Adequate hematological function, adequate liver function and renal function.
    
              -  Able to comply with the required protocol and follow-up procedures, and able to
                 receive oral medications.
    
              -  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 besides four cycles of adjuvant chemotherapy,
                 radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib,
                 cetuximab, trastuzumab).
    
              -  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:Disease-Free Survival
    Time Frame:5 years after the last patient is randomized
    Safety Issue:
    Description:Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.

    Secondary Outcome Measures

    Measure:Overall Survival
    Time Frame:5 years after the last patient is randomized
    Safety Issue:
    Description:Overall survival was assessed from randomization to death as a result of any cause.
    Measure:Number of Participants with Adverse Events
    Time Frame:2 years
    Safety Issue:
    Description:To assess if the addition of icotinib to chemotherapy is safe.
    Measure:Change from baseline in patient reported Lung Cancer Functional Assessment
    Time Frame:2 years
    Safety Issue:
    Description:Quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire.

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Sun Yat-sen University

    Last Updated