Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA NSCLC With EGFR-mutation

• Status: Active, not recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage II-IIIA non-small cell lung cancer patients with EGFR mutation. The primary endpoint is disease-free survival.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.; Betta Pharmaceuticals Co.,Ltd.
• Treatments: Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• Pathologically confirmed non-small cell lung cancer after surgical resection

• Stage II-IIIA disease according to 7th edition of TNM staging

• Positive EGFR gene mutation (19/21)

• ECOG 0-1

• At least 1-year life expectancy

• Adequate organ function

Exclusion Criteria:

• Previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc

• Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ

• Pneumonectomy of right lung

• Any unresolved chronic toxicity from previous anticancer therapy

• Allergic to study drug