High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC

A Phase II Study of High-dose Icotinib in Previously Treated Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor Mutation

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.

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