Clinical Trials /

High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation

NCT02404675

Description:

This randomized, open-label study is aimed to evaluate the efficacy of high-dose icotinib in treating advanced non-small cell lung cancer patients with positive EGFR 21 exon mutation.

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

Recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation
  • Official Title: High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation (INCREASE): a Randomized, Open-label Study

Clinical Trial IDs

  • ORG STUDY ID: AKTN-NSCLC-01
  • NCT ID: NCT02404675

Conditions

  • NSCLC

Interventions

DrugSynonymsArms
icotinibconmana21 icotinib (250mg)

Purpose

This randomized, open-label study is aimed to evaluate the efficacy of high-dose icotinib in treating advanced non-small cell lung cancer patients with positive EGFR 21 exon mutation.

Trial Arms

NameTypeDescriptionInterventions
21 icotinib (250mg)ExperimentalPatients with EGFR 21 exon positive are randomly assigned to higher dose icotinib group to receive icotinib with a dose of 250 mg three times per day, till progressive disease or unaccepted toxicity.
  • icotinib
21 icotinib (125mg)Active ComparatorPatients with EGFR 21 exon positive are randomly assigned to routine dose icotinib group to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity
  • icotinib
19 icotinib (125mg)ExperimentalPatients with EGFR del 19 exon positive are assigned to routine dose icotinib group to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity
  • icotinib

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients
             confirmed by sputum cytology)

          -  Positive EGFR 21 exon mutation or 19 exon deletion

          -  Age 18-75 years old with performance status of 0 to 2

          -  With a measurable disease(longest diameters >=10mm with Spiral computed tomography
             (CT)and >=20mm with conventional CT) according to RECIST Criteria

          -  Adequate hematological, biochemical and organ functions.

        Exclusion Criteria:

          -  Severe systemic disease out of control such as unstable or uncompensated
             respiratory,cardiac,liver,renal diseases.

          -  Evidence of interstitial lung diseases

          -  Evidence of any other significant clinical disorder or laboratory finding that makes
             it undesirable for the subject to participate in the study
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival
Time Frame:12 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall survival
Time Frame:20 months
Safety Issue:
Description:
Measure:Objective response rates
Time Frame:12 weeks
Safety Issue:
Description:

Details

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

Last Updated

July 27, 2017