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

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

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.

Study Overview

• Status: Terminated
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: 6-month Icotinib; Drug: 12-month icotinib

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.

• Study Type: Interventional
• Enrollment (Actual): 251
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 6-month icotinib; Icotinib 125 mg three times daily (375 mg per day) by mouth for 6 months	Drug: 6-month Icotinib; 125 mg three times daily (375 mg per day) by mouth for 6 months; Other Names: BPI-2009; Conmana
Experimental: 12-month icotinib; Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months	Drug: 12-month icotinib; 125 mg three times daily (375 mg per day) by mouth for 12 months; Other Names: BPI-2009; Conmana
No Intervention: Chemotherapy alone; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall survival was assessed from randomization to death as a result of any cause.	5 years after the last patient is randomized
Number of Participants with Adverse Events	To assess if the addition of icotinib to chemotherapy is safe.	2 years
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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Si-Yu Wang, MD, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: November 21, 2013
• First Submitted That Met QC Criteria: November 21, 2013
• First Posted (Estimated): November 27, 2013

Study Record Updates

• Last Update Posted (Actual): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 1, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: GASTO1002; wsy003 (Other Identifier: Guangdong Province Association Study of Thoracic Oncology)