Clinical Trials /

Icotinib in Non-small Cell Lung Cancer Patients With Uncommon EGFR Mutation

NCT02961270

Description:

This study aims to evaluate the efficacy of icotinib, a first generation EGFR TKI, in non-small cell lung cancer patients harboring uncommon EGFR mutation

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

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Icotinib in Non-small Cell Lung Cancer Patients With Uncommon EGFR Mutation
  • Official Title: Clinical Activity of Icotinib in Patients With Advanced Non-small-cell Lung Cancer Harbouring Uncommon EGFR Mutations: a Single-arm, Prospective, Phase 2 Study

Clinical Trial IDs

  • ORG STUDY ID: CAMS-ZH-001
  • NCT ID: NCT02961270

Conditions

  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
Icotinibicotinib

Purpose

This study aims to evaluate the efficacy of icotinib, a first generation EGFR TKI, in non-small cell lung cancer patients harboring uncommon EGFR mutation

Trial Arms

NameTypeDescriptionInterventions
icotinibExperimentalpatients will be administered study drug (icotinib) until disease progression or unacceptable toxicity
  • Icotinib

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with stage IIIB/IV non-small cell lung cancer

          -  Patients with uncommon epidermal growth factor receptor (EGFR) mutation

          -  Targeted-therapy-naive patients

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

          -  Evaluable target lesions according to RECIST 1.1 for tumour response assessment

        Exclusion Criteria:

          -  Wild-type EGFR

          -  Positive 19 del and/or 21 L858R mutation

          -  Previous treatment with EGFR TKIs such as gefitinib, erlotinib, and afatinib

          -  Patients who have documented history of interstitial lung disease
      
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:10 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:tumor response rate
Time Frame:2 months
Safety Issue:
Description:
Measure:overall survival
Time Frame:24 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Chinese Academy of Medical Sciences

Last Updated

November 10, 2016