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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02272127
Recruitment Status : Recruiting
First Posted : October 22, 2014
Last Update Posted : October 22, 2014
Information provided by (Responsible Party):
Kaican Cai, Nanfang Hospital of Southern Medical University

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.

Condition or disease Intervention/treatment Phase
NSCLC Drug: icotinib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intercalated Combination of Chemotherapy Plus Icotinib for Patients Undergoing Resection of EGRF Mutation-positive Non-small-cell Lung Cancer
Study Start Date : July 2014
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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 Measures :
  1. Number of Participants with Adverse Effects [ Time Frame: duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02272127

Contact: Kaican Cai, MD 8620-61641822
Contact: Siyang Feng, MM

China, Guangdong
Nanfang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Kaican Cai, MD    8620-61641822   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Principal Investigator: Kaican Cai, MD Nanfang Hospital of Southern Medical University

Responsible Party: Kaican Cai, Chief Physician,Associate Professor, Nanfang Hospital of Southern Medical University Identifier: NCT02272127     History of Changes
Other Study ID Numbers: NFEC-2014-069
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: October 2014

Keywords provided by Kaican Cai, Nanfang Hospital of Southern Medical University:
EGFR tyrosine kinase inhibitor

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases