Status:

COMPLETED

First Line IRESSA™ Versus Carboplatin/Paclitaxel in Asia

Lead Sponsor:

AstraZeneca

Conditions:

Non-Small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2010

Estimated Enrollment :

1329 Patients enrolled

Trial Details

Trial ID

NCT00322452

Start Date

March 1 2006

End Date

June 1 2010

Last Update

November 7 2013

Active Locations (56)

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Page 1 of 14 (56 locations)

1

Research Site

Fuzhou, Fujian, China

2

Research Site

Guangzhou, Guangdong, China

3

Research Site

Wuhan, Hubei, China

4

Research Site

Nanjing, Jiangsu, China