Clinical Trials /

Study of Chemotherapy Plus Icotinib to Treat EGFR Mutation-positive Non-small-cell Lung Cancer

NCT02272127

Description:

Non-small-cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor (EGFR) mutations are exquisitely sensitive to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) which is widely used in advanced patients. Whether treatment with EGFR-TKIs improves outcomes in patients with resected NSCLC harboring EGFR mutations is still under investigated. This study aims to observe and compare the efficacy and safety of intercalated combination of chemotherapy plus icotinib in patients undergoing resection of EGRF mutation-positive non-small cell lung cancer stagingⅠB (with high risk factor) to ⅢA.

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

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Chemotherapy Plus Icotinib to Treat EGFR Mutation-positive Non-small-cell Lung Cancer
  • Official Title: Intercalated Combination of Chemotherapy Plus Icotinib for Patients Undergoing Resection of EGRF Mutation-positive Non-small-cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: NFEC-2014-069
  • NCT ID: NCT02272127

Conditions

  • NSCLC

Interventions

DrugSynonymsArms
icotinibintercalated treatment

Purpose

Non-small-cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor (EGFR) mutations are exquisitely sensitive to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) which is widely used in advanced patients. Whether treatment with EGFR-TKIs improves outcomes in patients with resected NSCLC harboring EGFR mutations is still under investigated. This study aims to observe and compare the efficacy and safety of intercalated combination of chemotherapy plus icotinib in patients undergoing resection of EGRF mutation-positive non-small cell lung cancer stagingⅠB (with high risk factor) to ⅢA.

Trial Arms

NameTypeDescriptionInterventions
intercalated treatmentExperimentalPatients will receive 4 cycles treatment: chemotherapy(day 1) plus intercalated icotinib(day 8-21) every 3 weeks, and then oral icotinib continuously for 2 years or until disease progression or unacceptable toxic effects
  • icotinib

Eligibility Criteria

        Inclusion Criteria:

          -  Patients undergoing completely resection of EGRF mutation-positive NSCLC

          -  Staging ⅠB (with high risk factor) to ⅢA

          -  PS<2

          -  Adequate hematological, biochemical and organ functions.

        Exclusion Criteria:

          -  Systemic anticancer therapy prior to surgery, other malignancies before or during the
             study, any unstable illness, women who were pregnant or lactating.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease free survival
Time Frame:from the date of surgery until the date of first confirmed disease relapse or metastasis, assessed up to 5 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of Participants with Adverse Effects
Time Frame:duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Nanfang Hospital of Southern Medical University

Trial Keywords

  • EGFR tyrosine kinase inhibitor

Last Updated

October 20, 2014