Phase II Iressa & Carbo/Gem in NSCLC

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: December 12, 2005
Last updated: June 11, 2009
Last verified: June 2009
The primary objective is to demonstrate in chemotherapy naïve patients with advanced (Stage IIIB or IV) NSCLC and ECOG PS 2 non-inferiority in progression free survival (PFS) for ZD1839 compared to gemcitabine/carboplatin.

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Gefitinib
Drug: Gemcitabine
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Phase II Study Of ZD1839 (IRESSA™) Versus Gemcitabine And Carboplatin In Chemotherapy-Naive Patients With Advanced (Stage IIIB OR IV) Non-Small Cell Lung Cancer And ECOG Performance Status 2

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Date of randomization to earliest date of objective disease progression ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: October 2004
Study Completion Date: June 2008
Arms Assigned Interventions
Active Comparator: 1
Gemcitabine + Carboplatin
Drug: Gemcitabine
intravenous injection
Other Name: Gemzar
Drug: Carboplatin
intravenous injection
Other Name: CBDCA
Experimental: 2
Drug: Gefitinib
oral tablet
Other Names:
  • ZD1839


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Advanced Non Small cell Lung Cell Lung cancer
  • Never received chemotherapy
  • Up and about 50% of waking hours

Exclusion Criteria:

  • Spread of lung cancer to the brain
  • Low level of white blood cells
  • Radiotherapy within 4 weeks

Patients were entered to this study, initiated in 2004, before the significance of predictive factors such as smoking history, adenocarcinoma histology and mutation status was described.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00264498

Canada, Quebec
Research Site
Montreal, Quebec, Canada
Sponsors and Collaborators
Study Director: AstraZeneca Canada Oncology Medical Director, MD AstraZeneca
  More Information

Additional Information:
No publications provided Identifier: NCT00264498     History of Changes
Other Study ID Numbers: 1839IL/0551 
Study First Received: December 12, 2005
Results First Received: June 11, 2009
Last Updated: June 11, 2009
Health Authority: Canada: Health Canada

Keywords provided by AstraZeneca:
Non-Small-Cell Lung Cancer
Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses processed this record on February 11, 2016