Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Advanced NSCLC

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomised, controlled, open-label, prospective trial is designed to assess the efficacy and safety of icotinib maintenance therapy after sequential Icotinib plus chemotherapy versus Icotinib maintenance therapy after chemotherapy in stage IIIB/IV non-small cell lung cancer patients with EGFR mutation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.; Betta Pharmaceuticals Co.,Ltd.
• Treatments: Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

• Stage IV or IIIB advanced non-small cell lung cancer patients

• Positive EGFR Mutation

• Non-progressive disease after first-line gemcitabine/cisplatin therapy

• Measurable lesion according to RECIST 1.1 with at least one measurable lesion

Exclusion Criteria:

• Previous anti-EGFR (epidermal growth factor receptor) monoclonal antibody or small molecular agent such as gefitinib, erlotinib and so on

• Patients with wild-type EGFR

• Evidence of interstitial lung diseases

• Severe hypersensitivity to icotinib or any of the excipients of this product.

• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study