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Icotinib Following Chemotherapy Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA NSCLC With EGFR Mutation (ICTAN)

Primary Purpose

Lung Cancer

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

6-month Icotinib

12-month icotinib

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

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

Inclusion Criteria:

Written informed consent provided.
Aged 18-75 years.
Had completely resected pathological confirmed stage IIA-IIIA NSCLC.
EGFR activating mutation in exon 19 or 21.
Had completed four cycles of platinum-based adjuvant chemotherapy.
Able to start the investigational therapy within 4 weeks after the completion of four cycles of adjuvant chemotherapy.
ECOG performance status of 0-1.
Had a life expectancy of 12 weeks or more.
Adequate hematological function, adequate liver function and renal function.
Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
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 besides four cycles of adjuvant chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
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 3

Arm Type

Experimental

No Intervention

Arm Label

6-month icotinib

12-month icotinib

Chemotherapy alone

Arm Description

Icotinib 125 mg three times daily (375 mg per day) by mouth for 6 months

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

No intervention

Outcomes

Primary Outcome Measures

Disease-Free Survival

Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.

Secondary Outcome Measures

Overall Survival

Overall survival was assessed from randomization to death as a result of any cause.

Number of Participants with Adverse Events

To assess if the addition of icotinib to chemotherapy is safe.

Change from baseline in patient reported Lung Cancer Functional Assessment

Quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire.

Full Information

NCT ID

NCT01996098

First Posted

November 21, 2013

Last Updated

August 25, 2018

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT01996098

Brief Title

Icotinib Following Chemotherapy Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA NSCLC With EGFR Mutation

Acronym

ICTAN

Official Title

A Multicenter, Randomized, Phase III Trial of Chemotherapy Followed by 6-month or 12-month Icotinib Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA Non-small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutation

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

January 2020 (Anticipated)

Study Completion Date

January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is studying icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation.

Detailed Description

Adjuvant chemotherapy is recommended for routine use in patients with fully resected stage IIA-IIIA non-small cell lung cancer (NSCLC). Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with advanced non-small cell lung cancer (NSCLC) with EGFR mutation. Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists. In the phase III ICOGEN trial, icotinib had non-inferiority efficacy to gefitinib with better safety. In phase II trial, chemotherapy followed by 6-month gefitinib as adjuvant therapy can confer longer disease-free survival compared with chemotherapy alone in patients with resected stage IIIA-N2 non-small cell lung cancer harboring EGFR mutations. This study is to studying 6-month or 12-month icotinib following chemotherapy to see how well it works compared to chemotherapy in treating patients with resected stage IIA-IIIA NSCLC harboring EGFR mutation.

6. Conditions and Keywords

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

Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

318 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

6-month icotinib

Arm Type

Experimental

Arm Description

Icotinib 125 mg three times daily (375 mg per day) by mouth for 6 months

Arm Title

12-month icotinib

Arm Type

Experimental

Arm Description

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

Arm Title

Chemotherapy alone

Arm Type

No Intervention

Arm Description

No intervention

Intervention Type

Drug

Intervention Name(s)

6-month Icotinib

Other Intervention Name(s)

BPI-2009, Conmana

Intervention Description

125 mg three times daily (375 mg per day) by mouth for 6 months

Intervention Type

Drug

Intervention Name(s)

12-month icotinib

Other Intervention Name(s)

BPI-2009, Conmana

Intervention Description

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

Primary Outcome Measure Information:

Title

Disease-Free Survival

Description

Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.

Time Frame

5 years after the last patient is randomized

Secondary Outcome Measure Information:

Title

Overall Survival

Description

Overall survival was assessed from randomization to death as a result of any cause.

Time Frame

5 years after the last patient is randomized

Title

Number of Participants with Adverse Events

Description

To assess if the addition of icotinib to chemotherapy is safe.

Time Frame

2 years

Title

Change from baseline in patient reported Lung Cancer Functional Assessment

Description

Quality of life as measured by the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) questionnaire.

Time Frame

2 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. Aged 18-75 years. Had completely resected pathological confirmed stage IIA-IIIA NSCLC. EGFR activating mutation in exon 19 or 21. Had completed four cycles of platinum-based adjuvant chemotherapy. Able to start the investigational therapy within 4 weeks after the completion of four cycles of adjuvant chemotherapy. ECOG performance status of 0-1. Had a life expectancy of 12 weeks or more. Adequate hematological function, adequate liver function and renal function. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications. 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 besides four cycles of adjuvant chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab). 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 87343439

wsysums@163.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Si-Yu Wang, MD

Organizational Affiliation

Sun Yat-sen University

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, MD

Phone

+86 20 87343439

wsysums@163.net

12. IPD Sharing Statement

Learn more about this trial

Icotinib Following Chemotherapy Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA NSCLC With EGFR Mutation

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