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

Betta Pharmaceuticals

Status and phase: Unknown; Phase 3

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Icotinib; Drug: Chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02448797

CCTC-1501 (Other Identifier)

BD-IC-IV-61

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

icotinib

Experimental group

Description:

125 mg three times daily (375 mg per day) orally for two years.

Treatment:

Drug: Icotinib

standard chemotherapy

Active Comparator group

Description:

Vinorelbine 25 mg/m\^2, intravenously guttae, day 1 and day 8, 21 days/cycle, 4 cycles. cisplatin 75 mg/m\^2, intravenously guttae, day 1, 21 days/cycle, 4 cycles. For adenocarcinoma: pemetrexed (500 mg/m\^2, day 1)/cisplatin (75 mg/m\^2, day 1) for 4 cycles.

Treatment:

Drug: Chemotherapy