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

Primary Purpose

NSCLC

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
icotinib
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSCLC focused on measuring EGFR tyrosine kinase inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanfang Hospital of Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intercalated treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Disease free survival

Secondary Outcome Measures

Number of Participants with Adverse Effects

Full Information

First Posted
September 27, 2014
Last Updated
October 20, 2014
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02272127
Brief Title
Study of Chemotherapy Plus Icotinib to Treat EGFR Mutation-positive Non-small-cell Lung Cancer
Official Title
Intercalated Combination of Chemotherapy Plus Icotinib for Patients Undergoing Resection of EGRF Mutation-positive Non-small-cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC
Keywords
EGFR tyrosine kinase inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intercalated treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
icotinib
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Effects
Time Frame
duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kaican Cai, MD
Phone
8620-61641822
Email
doc_cai@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Siyang Feng, MM
Email
fengsy89@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaican Cai, MD
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaican Cai, MD
Phone
8620-61641822
Email
doc_cai@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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