Icotinib for Completed Resected IB NSCLC With EGFR Mutation (CORIN)

July 29, 2021 updated by: Si-Yu Wang, Sun Yat-sen University

A Randomized, Phase II Trial of Icotinib Versus Observation as Adjuvant Treatment in Stage IB Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutation

This phase II trial studies how well icotinib works in treating patients with completely resected stage IB NSCLC harboring EGFR mutation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Adjuvant chemotherapy have shown little evidence of survival benefit in patients with stages IB non-small cell lung cancer (NSCLC) after complete resection. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with EGFR mutant non-small cell lung cancer (NSCLC). Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. In the phase III ICOGEN trial, icotinib had non-inferiority efficacy to gefitinib with better safety. This study is studying icotinib to see how well it works in treating patients with fully resected stage IB NSCLC harboring EGFR mutation.

Study Type

Interventional

Enrollment (Anticipated)

128

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 Contact

  • Name: Si-Yu Wang, MD
  • Phone Number: +86 20 87343314
  • Email: wsysums@163.net

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • 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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent provided.
  • Males or females, Aged 18-75 years.
  • Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
  • Had completely resected pathological confirmed stage IIA-IIIA NSCLC.
  • EGFR activating mutation in exon 19 or 21.
  • Patient who can start the investigational therapy within 3-6 weeks after the complete resection.
  • ECOG performance status of 0-1.
  • Had a life expectancy of 12 weeks or more.
  • Adequate hematological function, adequate liver function and renal function.
  • Female patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.

Exclusion Criteria:

  • Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
  • Inability to comply with protocol or study procedures.
  • Had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder.
  • Any evidence confirmed tumor recurrence before investigational therapy.
  • Known severe hypersensitivity to icotinib or any of the excipients of this product.
  • Evidence of clinically active interstitial lung disease.
  • Eye inflammation not fully controlled or conditions predisposing the subject to this.
  • Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
  • Known human immunodeficiency virus (HIV) infection.
  • Pregnancy or breast-feeding women.
  • Ingredients mixed with small cell lung cancer patients.
  • History of neurologic or psychiatric disorders.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Icotinib 125 mg three times daily (375 mg per day) orally for 12 months.
Drug: Icotinib
Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months.
Other Names:
  • BPI-2009
  • Conmana
No Intervention: Observation group
Observation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: From randomization to the time of disease recurrence or death as a result of any cause, assessed up to 5 years
DFS will be estimated by the method of Kaplan-Meier
From randomization to the time of disease recurrence or death as a result of any cause, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From randomization to the time of death as a result of any cause, assessed up to 5 years
OS will be estimated by the method of Kaplan-Meier
From randomization to the time of death as a result of any cause, assessed up to 5 years
Number of Participants with Adverse Events
Time Frame: Up to 5 years
The NCI Common Terminology Criteria for Adverse Events version 3.0 will be used
Up to 5 years

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Si-Yu Wang, MD, Guangdong Province Association Study of Thoracic Oncology

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 (Actual)

January 1, 2015

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

October 8, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (Estimate)

October 15, 2014

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

July 29, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GASTO1003
  • wsy004 (Other Identifier: Guangdong Province Association Study of Thoracic Oncology)

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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