High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC

Carcinoma, Non-Small-Cell Lung Clinical Trial

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT02960607
• Other study ID #: CH-L-059
• Status: Recruiting
• Phase: Phase 2
• First received: November 8, 2016
• Last updated: November 16, 2016
• Start date: November 2016

Study information

• Verified date: November 2016
• Source: Chinese Academy of Medical Sciences
• Contact: Yutao Liu
• Email: 13911901165[@]139.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Icotinib
Icotinib (250mg tid) until disease progression or unacceptable toxicities occurred.

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free survival		2 years	Yes