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

Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01996098
• Other study ID #: GASTO1002
• Secondary ID: wsy003
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2014
• Est. completion date: January 2023

Study information

• Verified date: August 2018
• Source: Sun Yat-sen University
• Contact: Si-Yu Wang, MD
• Phone: + 86 20 87343439
• Email: wsysums[@]163.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 318
• Est. completion date: January 2023
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• 6-month Icotinib
125 mg three times daily (375 mg per day) by mouth for 6 months
• 12-month icotinib
125 mg three times daily (375 mg per day) by mouth for 12 months

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-Free Survival	Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.	5 years after the last patient is randomized
Secondary	Overall Survival	Overall survival was assessed from randomization to death as a result of any cause.	5 years after the last patient is randomized
Secondary	Number of Participants with Adverse Events	To assess if the addition of icotinib to chemotherapy is safe.	2 years
Secondary	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.	2 years