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

Betta Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

NSCLC

Treatments

Drug: Icotinib

Drug: Chemotherapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT01719536

BD-IC-IV36

Details and patient eligibility

About

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.

Full description

This study is designed to evaluate the efficacy and safety of icotinib and pemetrexed-based first-line induction and maintenance chemotherapy in advanced lung adenocarcinoma with EGFR-mutation，primary endpoint is progress-free survival，second endpoints include overall survival, time to progression, and so on.

Enrollment

296 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.