Phase II Iressa & Carbo/Gem in NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00264498
Recruitment Status : Completed
First Posted : December 13, 2005
Results First Posted : August 3, 2009
Last Update Posted : August 3, 2009
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Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Gefitinib Drug: Gemcitabine Drug: Carboplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2004
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Date of randomization to earliest date of objective disease progression ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00264498

Canada, Quebec
Research Site
Montreal, Quebec, Canada
Sponsors and Collaborators
Study Director: AstraZeneca Canada Oncology Medical Director, MD AstraZeneca Identifier: NCT00264498     History of Changes
Other Study ID Numbers: 1839IL/0551
First Posted: December 13, 2005    Key Record Dates
Results First Posted: August 3, 2009
Last Update Posted: August 3, 2009
Last Verified: June 2009

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors