Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy

Safety and Efficacy of Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy: a Single-arm, Phase 3 Study

This study was a single-arm, multi-center, prospective, phase 3 trial aimed to evaluate the efficacy and safety of icotinib in patients with locally advanced or metastatic NSCLC after failure of at least one platinum-based chemotherapy regimen.

Inclusion Criteria:

• Histologically or cytologically confirmed locally advanced/metastatic (stage IIIB/stage IV, using the American Joint Committee on Cancer [AJCC] 6th edition of tumor-node-metastasis [TNM] staging system) NSCLC patients
• Progressed after at least one platinum-based chemotherapy regimen at entry
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
• At least one measurable lesion by Response Evaluation Criteria in Solid Tumors version 1.0
• Adequate hematologic and biochemical values

Exclusion Criteria:

• Patients with symptomatic brain metastases
• Malignant tumor within the previous five years
• Severe infection; congestive heart failure
• Previous treatment with drugs targeting EGFR
• History of interstitial lung disease