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

NCT ID: NCT01996098

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 251 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2024-02-15

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

6-month icotinib

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

Group Type: EXPERIMENTAL

6-month Icotinib

Intervention Type: DRUG

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

12-month icotinib

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

Group Type: EXPERIMENTAL

12-month icotinib

Intervention Type: DRUG

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

Chemotherapy alone

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

6-month Icotinib

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

Intervention Type: DRUG

12-month icotinib

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

Intervention Type: DRUG

Other Intervention Names

BPI-2009; Conmana; BPI-2009; Conmana

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Si-Yu Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Si-Yu Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

wsy003

Identifier Type: OTHER

Identifier Source: secondary_id

GASTO1002

Identifier Type: -

Identifier Source: org_study_id