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

Primary Purpose

Lung Neoplasms, Squamous Cell Lung Cancer, Adenocarcinoma of the Lung

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Icotinib

About this trial

This is an interventional treatment trial for Lung Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Observation group

Arm Description

Icotinib 125 mg three times daily (375 mg per day) orally for 12 months.

Observation.

Outcomes

Primary Outcome Measures

Disease-free survival

DFS will be estimated by the method of Kaplan-Meier

Secondary Outcome Measures

Overall survival

OS will be estimated by the method of Kaplan-Meier

Number of Participants with Adverse Events

The NCI Common Terminology Criteria for Adverse Events version 3.0 will be used

Full Information

NCT ID

NCT02264210

First Posted

October 8, 2014

Last Updated

July 29, 2021

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02264210

Brief Title

Icotinib for Completed Resected IB NSCLC With EGFR Mutation

Acronym

CORIN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Recruiting

Study Start Date

January 2015 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Neoplasms, Squamous Cell Lung Cancer, Adenocarcinoma of the Lung, Adenosquamous Cell Lung Cancer, Large Cell Lung Cancer, Bronchial Neoplasms, Stage IB Non-small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

Icotinib 125 mg three times daily (375 mg per day) orally for 12 months.

Arm Title

Observation group

Arm Type

No Intervention

Arm Description

Observation.

Intervention Type

Drug

Intervention Name(s)

Icotinib

Other Intervention Name(s)

BPI-2009, Conmana

Intervention Description

Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months.

Primary Outcome Measure Information:

Title

Disease-free survival

Description

DFS will be estimated by the method of Kaplan-Meier

Time Frame

From randomization to the time of disease recurrence or death as a result of any cause, assessed up to 5 years

Secondary Outcome Measure Information:

Title

Overall survival

Description

OS will be estimated by the method of Kaplan-Meier

Time Frame

From randomization to the time of death as a result of any cause, assessed up to 5 years

Title

Number of Participants with Adverse Events

Description

The NCI Common Terminology Criteria for Adverse Events version 3.0 will be used

Time Frame

Up to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Si-Yu Wang, MD

Phone

+86 20 87343314

wsysums@163.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Si-Yu Wang, MD

Organizational Affiliation

Guangdong Province Association Study of Thoracic Oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Si-Yu Wang, Doctor

Phone

+86 20 87343439

wsysums@163.net

12. IPD Sharing Statement

Learn more about this trial

Icotinib for Completed Resected IB NSCLC With EGFR Mutation

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