Clinical Trials /

High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC

NCT02960607

Description:

The purpose of this study is to investigate whether high-dose icotinib treatment beyond disease progression is beneficial for NSCLC patients who have EGFR mutation and who have responded to EGFR TKI.

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

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC
  • Official Title: A Phase II Study of High-dose Icotinib in Previously Treated Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor Mutation

Clinical Trial IDs

  • ORG STUDY ID: CH-L-059
  • NCT ID: NCT02960607

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DrugSynonymsArms
IcotinibIcotinib

Purpose

The purpose of this study is to investigate whether high-dose icotinib treatment beyond disease progression is beneficial for NSCLC patients who have EGFR mutation and who have responded to EGFR TKI.

Trial Arms

NameTypeDescriptionInterventions
IcotinibExperimental250mg, tid until disease progression or unacceptable toxicities occurred
  • Icotinib

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed stage IIIB/IV NSCLC

          -  Investigator confirmed progression according RECIST 1.1 during previous icotinib
             treatment

          -  Patients whose tumors:

               -  are EGFR mutation-positive or

               -  T790M mutation-negative

          -  Performance status: WHO 0-2

          -  Measurable disease according to RECIST 1.1

               -  at least one measureable lesion .if only one measureable lesion, the biological
                  nature must be confirmed by cytology or histology

               -  a single diameter of lesion could be measured by at least one of the following
                  methods: Chest or abdominal computed tomography(CT)or magnetic resonance
                  imaging(MRI),conventional methods of diameter at least 20mm diameter spiral CT OR
                  at least 10mm

          -  ANC ≥ 1.5*109/L, Platelets ≥ 75*109/L, Hgb≥ 9g/dL, Alanine amino transferase ≤ 2 ×
             Upper limit of normal (ULN), Alkaline phosphatase ≤ 2.5 × ULN (< 5 × ULN if liver
             metastases), Serum Creatinine ≤ 1.5 × ULN

          -  Women of childbearing age must have a pregnancy test 7 days before treatment and the
             result were negative ,men of childbearing age: surgical sterilization or treatment
             during and after the end of three months to take contraceptive measures

          -  Patient must be able to comply with the protocol

        Exclusion Criteria:

          -  Patient with symptomatic central nervous system metastases

          -  Patient has known active hepatitis B or C, or HIV infection

          -  Pregnant or breastfeeding.

          -  Patient with uncontrolled undercurrent illness or circumstances that could limit
             compliance with 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:2 years
Safety Issue:
Description:

Details

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

Last Updated

November 16, 2016