Clinical Trials /

Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma

NCT02125240

Description:

The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.

Related Conditions:
  • Lung Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma
  • Official Title: Icotinib as an Adjuvant Therapy for Stage II-IIIA Adenocarcinoma With EGFR Mutation: A Placebo-controlled, Randomized, Double-blind, Phase III Study

Clinical Trial IDs

  • ORG STUDY ID: BD-IC-IV-59
  • NCT ID: NCT02125240

Conditions

  • EGFR Positive Non-small Cell Lung Cancer
  • Adenocarcinoma

Interventions

DrugSynonymsArms
IcotinibBPI-2009, ConmanaIcotinib
PlaceboPlacebo

Purpose

The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.

Detailed Description

      This study is designed to compare 3 years of disease-free survival (DFS) of Icotinib and
      placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.

      Primary Outcome Measure:

      Disease-free survival between Icotinib group and placebo group.

      Secondary Outcome Measures:

      Overall survival between Icotinib group and placebo group. Lung cancer symptoms and
      health-related quality of life (HRQoL) . Number of participants with adverse events.
    

Trial Arms

NameTypeDescriptionInterventions
IcotinibExperimental125 mg three times daily (375 mg per day) by mouth
  • Icotinib
PlaceboActive Comparator1 tablet three times daily by mouth
  • Placebo

Eligibility Criteria

        Inclusion Criteria:

          -  Pathologically confirmed lung adenocarcinoma after surgical resection

          -  Stage II-IIIA disease according to 7th edition of TNM staging

          -  Patients must harbor sensitive EGFR gene mutation (19/21)

          -  Received four cycles of platinum-based adjuvant chemotherapy.There are many different
             kinds of chemotherapy regimens including vinorelbine, gemcitabine, docetaxel,
             paclitaxel, pemetrexed plus cisplatin or carboplatin.The first cycle of chemotherapy
             with cisplatin dose of 75 mg / m2 ± 10% or carboplatin AUC = 5 ± 10% to calculate the
             dose of chemotherapy

        Exclusion Criteria:

          -  Previous systemic anti-tumor therapy, including chemotherapy or targeted
             therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine
             kinase inhibitor, etc

          -  Presence of metastatic disease

          -  Other co-existing malignancies or malignancies diagnosed within the last 5 years with
             the exception of basal cell carcinoma or cervical cancer in situ

          -  Any unresolved chronic toxicity from previous anticancer therapy

          -  Received antitumor radiation therapy (except for the stage IIIA N2 patients who
             received adjuvant radiotherapy after surgery)
      
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:36 months
Safety Issue:
Description:DFS was defined as the time from the date of first dose of study medication to the date of death due to disease recurrence or disease progression.

Secondary Outcome Measures

Measure:Overall survival
Time Frame:60 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:Lung cancer symptoms and health-related quality of life (HRQoL) differences
Time Frame:60 months
Safety Issue:
Description:
Measure:Number of participants with adverse events
Time Frame:36 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Betta Pharmaceuticals Co.,Ltd.

Last Updated

October 30, 2017