Clinical Trials /

Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma

NCT01665417

Description:

This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance treatment with icotinib.

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

Unknown status

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma
  • Official Title: Randomized, Open Label, Positive Controlled, Multicenter Trial to Evaluate Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma

Clinical Trial IDs

  • ORG STUDY ID: BD-IC-IV08
  • NCT ID: NCT01665417

Conditions

  • EGFR Positive Non-small Cell Lung Cancer
  • Adenocarcinoma

Interventions

DrugSynonymsArms
ExperimentalBPI-2009, CommanaExperimental Icotinib
ChemotherapyPemetrexe, ALIMTAChemotherapy Regimen 1
ChemotherapyDocetaxel, TaxotereChemotherapy Regimen 1

Purpose

This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance treatment with icotinib.

Detailed Description

      This study is designed to compare the efficacy and safety of first-line icotinib treatment
      and first-line chemotherapy followed by maintenance with icotinib.

      Primary endpoint:

      Progression-free survival between first-line icotinib treatment and first-line chemotherapy
      followed by maintenance with icotinib

      Secondary endpoint:

        1. Overall survival between icotinib and chemotherapy

        2. Time to Progression between icotinib and chemotherapy

        3. Objective response rate and disease control rate between icotinib and chemotherapy
    

Trial Arms

NameTypeDescriptionInterventions
Experimental IcotinibExperimentalIcotinib: 125mg, oral administration, three times per day.
  • Experimental
Chemotherapy Regimen 1Active ComparatorChemotherapy Regimen 1:Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.
  • Chemotherapy
  • Chemotherapy
Chemotherapy Regimen 2Active ComparatorChemotherapy Regimen 2:Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.
  • Chemotherapy
  • Chemotherapy

Eligibility Criteria

        Inclusion Criteria:

          -  Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at
             least one lesion that can be accurately measured in at least one dimension (longest
             diameter to be recorded on CT); Patients must have previously untreated locally
             advanced or metastatic NSCLC; Patients must have lung cancer with a documented EGFR
             activating mutation (exon 19 deletion, L858R).

        Exclusion Criteria:

          -  Prior chemotherapy Prior treatment with gefitinib, erlotinib, or other drugs that
             target EGFR Patients must not be receiving any other investigational agents Any
             evidence of interstitial lung disease
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival
Time Frame:8 months
Safety Issue:
Description:PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.

Secondary Outcome Measures

Measure:Overall survival
Time Frame:24 months
Safety Issue:
Description:OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive.
Measure:Time to Tumor Progression
Time Frame:8 months
Safety Issue:
Description:TTP was defined as the time from the date of first dose of study medication to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.
Measure:Objective response rate
Time Frame:3 months
Safety Issue:
Description:Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors(RECIST)1.1.
Measure:Number of participants with adverse events
Time Frame:24 months
Safety Issue:
Description:Adverse events assessed by CTCAE4.0.

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Betta Pharmaceuticals Co.,Ltd.

Trial Keywords

  • Icotinib
  • EGFR positive mutation
  • First-line treatment
  • Maintenance treatment

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