Study of Chemotherapy Plus Icotinib to Treat EGFR Mutation-positive Non-small-cell Lung Cancer

October 20, 2014 updated by: Kaican Cai, Nanfang Hospital of Southern Medical University

Intercalated Combination of Chemotherapy Plus Icotinib for Patients Undergoing Resection of EGRF Mutation-positive Non-small-cell Lung Cancer

Non-small-cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor (EGFR) mutations are exquisitely sensitive to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) which is widely used in advanced patients. Whether treatment with EGFR-TKIs improves outcomes in patients with resected NSCLC harboring EGFR mutations is still under investigated. This study aims to observe and compare the efficacy and safety of intercalated combination of chemotherapy plus icotinib in patients undergoing resection of EGRF mutation-positive non-small cell lung cancer stagingⅠB (with high risk factor) to ⅢA.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital of Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing completely resection of EGRF mutation-positive NSCLC
  • Staging ⅠB (with high risk factor) to ⅢA
  • PS<2
  • Adequate hematological, biochemical and organ functions.

Exclusion Criteria:

  • Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intercalated treatment
Patients will receive 4 cycles treatment: chemotherapy(day 1) plus intercalated icotinib(day 8-21) every 3 weeks, and then oral icotinib continuously for 2 years or until disease progression or unacceptable toxic effects
Drug: icotinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease free survival
Time Frame: from the date of surgery until the date of first confirmed disease relapse or metastasis, assessed up to 5 years
from the date of surgery until the date of first confirmed disease relapse or metastasis, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Effects
Time Frame: duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years
duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Investigators

  • Principal Investigator: Kaican Cai, MD, Nanfang Hospital of Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

September 27, 2014

First Submitted That Met QC Criteria

October 20, 2014

First Posted (Estimate)

October 22, 2014

Study Record Updates

Last Update Posted (Estimate)

October 22, 2014

Last Update Submitted That Met QC Criteria

October 20, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2014-069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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