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.

Study Overview

• Status: Unknown
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Icotinib

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Icotinib; 250mg, tid until disease progression or unacceptable toxicities occurred	Drug: Icotinib; Icotinib (250mg tid) until disease progression or unacceptable toxicities occurred.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression Free survival	2 years

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: November 8, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (Estimate): November 9, 2016

Study Record Updates

• Last Update Posted (Estimate): November 18, 2016
• Last Update Submitted That Met QC Criteria: November 16, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CH-L-059