High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC

Phase 2

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Icotinib

• Registration Number: NCT02960607
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-09
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18
• Primary Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Icotinib	Icotinib	250mg, tid until disease progression or unacceptable toxicities occurred

Primary Outcome Measures

Name	Time	Method
Progression Free survival	2 years

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China