Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients

• Status: Completed
• Trial end date: 2017-02-07
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare icotinib with induction and maintenance chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation.

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

Details

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

Criteria

Inclusion Criteria:

• Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.

• Positive EGFR Mutation.

• No previous systemic anticancer therapy.

• Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.

• Provision of written informed consent.

Exclusion Criteria:

• Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.

• Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).

• Known 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.