MedTrace Logo

Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients

NCT01040780 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 399

Last updated 2014-02-14

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine whether Icotinib is at least non-inferior to Gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients after one or two chemotherapies.

Conditions

Interventions

DRUG

Icotinib

125 mg three times daily (375 mg per day) by mouth

DRUG

Gefitinib

250 mg every 24 hours by mouth

Sponsors & Collaborators

  • Betta Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yan Sun, M.D. · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Li Zhang, M.D. · Sun Yat-sen University

  • Fenlai Tan, M.D./Ph.D. · Zhejiang Betapharma Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-03-31
Completion
2011-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01040780 on ClinicalTrials.gov