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First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: June 26, 2006
Last updated: June 24, 2010
Last verified: June 2010
The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of Gefitinib.

Condition Intervention Phase
Pulmonary Cancer
Drug: Gefitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multi-centre Study to Evaluate Efficacy and Safety of Gefitinib as the First-line Treatment for Locally Advanced (IIIB), Metastatic (IV) or Recurrent Pulmonary Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation.

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria. [ Time Frame: baseline to 12 months ]

    Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients.

    RECIST criteria:

    CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria

Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: baseline to 4 months ]
    Progression free survival calculated using Kaplan-Meier Product Limit. Median PFS was not able to be calculated because the rate of PFS was below 50% at the end of follow-up period. Therefore, PFS percentage at 4 months is provided.

  • Overall Survival (OS) [ Time Frame: baseline to 12 months ]
    Median Overal survival was not able to be calculated because the rate of OS was below 50% at the end of follow-up period. Therefore, OS percentage at 12 months is provided.

  • Safety Profile: Participants With Adverse Events [ Time Frame: baseline to end of study ]
    Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section.

Enrollment: 46
Study Start Date: March 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gefitinib
Gefitinib 250mg tablet once daily
Drug: Gefitinib
250mg tablet oral tablet once daily
Other Names:
  • ZD1839


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients require histological biopsy and paraffin block more than 5mg from the original tumour or metastatic site to perform EGFR mutational analysis
  • WHO Performance Status 0-2
  • No prior chemotherapy, biological or immunological therapy/surgery

Exclusion Criteria:

  • Any evidence of clinically active interstitial lung disease
  • Newly diagnosed CNS metastases that have not yet been definitively treated with surgery /radiation
  • Patients with previously diagnosed and treated CNS metastases or spinal cord compression
  Contacts and Locations
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Please refer to this study by its identifier: NCT00344773

Korea, Republic of
Research Site
Seongnam-Si, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Sponsors and Collaborators
Study Director: HyeJong Yoo AstraZeneca
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00344773     History of Changes
Other Study ID Numbers: D7913L00056
Study First Received: June 26, 2006
Results First Received: December 19, 2008
Last Updated: June 24, 2010

Keywords provided by AstraZeneca:
Locally advanced (IIIB) pulmonary adenocarcinoma with EGFR mutation
Metastatic (IV) pulmonary adenocarcinoma with EGFR mutation
Recurrent pulmonary adenocarcinoma with EGFR mutation

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Mitosis Modulators processed this record on May 25, 2017