Overview

First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia

Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients with the objective of demonstrating non-inferiority.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Albumin-Bound Paclitaxel
Carboplatin
Gefitinib
Paclitaxel
Criteria
Inclusion Criteria:

- Locally advanced Stage IIIB not amenable to local therapy or Stage IV (metastatic)
NSCLC with adenocarcinoma histology.

- Never smokers or light ex-smokers.(ceased smoking at least 15 years before Day 1 of
study treatment and 10 pack-years or fewer)

Exclusion Criteria:

- Had prior chemotherapy, biological (including targeted therapies such as EGFR and
vascular epidermal growth factor (VEGF) inhibitors) or immunological therapy.

- Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline.