Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation (ICAPE)

Betta Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Icotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02044328

BD-IC-IV57

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 IIA-IIIA adenocarcinoma patients with EGFR mutation. The primary endpoint is disease-free survival.

Enrollment: 79 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patients present with operable stage IIA-IIIA (N0-1) lung adenocarcinoma with 19 or 21 exon mutation
• The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy
• The patients' Eastern Cooperative Oncology Group scores are ≤ 0-1
• The patients signed the written informed consent

Exclusion criteria

• Patients with unresected tumor
• Wild EGFR type
• Allergic to the study drug
• Patients have severe non-cancerous diseases
• Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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79 participants in 1 patient group

Icotinib

Experimental group

Description:

Patients receive icotinib 125 mg three times daily as adjuvant chemotherapy with for 18 months after surgery.

Treatment:

Drug: Icotinib