Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.; Betta Pharmaceuticals Co.,Ltd.

Criteria

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