Clinical Trials /

Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation

NCT02044328

Description:

Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage IIA-IIIA adenocarcinoma patients with EGFR mutation. The primary endpoint is disease-free survival.

Related Conditions:
  • Lung Adenocarcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation
  • Official Title: Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation: a Prospective, Exploratory Study

Clinical Trial IDs

  • ORG STUDY ID: BD-IC-IV57
  • NCT ID: NCT02044328

Conditions

  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
IcotinibCommana, BPI-2009Icotinib

Purpose

Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage IIA-IIIA adenocarcinoma patients with EGFR mutation. The primary endpoint is disease-free survival.

Trial Arms

NameTypeDescriptionInterventions
IcotinibExperimentalPatients receive icotinib 125 mg three times daily as adjuvant chemotherapy with for 18 months after surgery.
  • Icotinib

Eligibility Criteria

        Inclusion Criteria:

          -  The patients present with operable stage IIA-IIIA (N0-1) lung adenocarcinoma with 19
             or 21 exon mutation

          -  The patients have no history of anti-cancer therapies including chemotherapy,
             radiation therapy

          -  The patients' Eastern Cooperative Oncology Group scores are ≤ 0-1

          -  The patients signed the written informed consent

        Exclusion Criteria:

          -  Patients with unresected tumor

          -  Wild EGFR type

          -  Allergic to the study drug

          -  Patients have severe non-cancerous diseases

          -  Patients are undergoing current administration of anti-cancer therapies, or are
             attending some other clinical trials
      
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:2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:1-year Survival Rates
Time Frame:1 year
Safety Issue:
Description:
Measure:3-year Survival Rates
Time Frame:3 years
Safety Issue:
Description:
Measure:Number of patients suffered adverse events
Time Frame:42 months
Safety Issue:
Description:Adverse events are evaluated and coded by Common Terminology Criteria for Adverse Events version 4.0

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Betta Pharmaceuticals Co.,Ltd.

Last Updated

July 1, 2016