Gefitinib After Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

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: NCT00091156
Recruitment Status : Terminated (low accrual)
First Posted : September 8, 2004
Last Update Posted : July 16, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether giving gefitinib after initial chemotherapy is effective in delaying the recurrence of non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying gefitinib to see how well it works compared to placebo in delaying tumor recurrence in patients who have undergone initial chemotherapy for stage IIIB or stage IV non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: gefitinib Procedure: adjuvant therapy Phase 3

Detailed Description:



  • Compare overall survival of patients with stage IIIB or IV non-small cell lung cancer that did not progress on prior first-line palliative induction chemotherapy when treated with adjuvant gefitinib vs placebo.


  • Compare progression-free survival of patients treated with these regimens.
  • Determine the safety and toxicity of gefitinib in these patients.

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to initial disease stage (IIIB vs IV), WHO performance status at the end of prior first-line palliative induction chemotherapy (0-1 vs 2), best patient response to prior first-line palliative induction chemotherapy (objective response vs stable disease), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral gefitinib once daily.
  • Arm II: Patients receive oral placebo once daily. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 598 patients (299 per treatment arm) will be accrued for this study within 8.5 years.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 598 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study of Follow Up With or Without Adjuvant Gefitinib (Iressa™) Following Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
Study Start Date : May 2004
Actual Primary Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib

Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Progression-free survival
  2. Toxicity as assessed by CTC

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed non-small cell lung cancer meeting 1 of the following stage criteria:

    • Stage IIIB

      • Pleural fluid and/or supraclavicular nodes allowed provided patient is not eligible for consolidation radiotherapy
    • Stage IV disease
  • No disease progression after 2-6 courses of prior platinum-containing first-line palliative induction chemotherapy
  • Brain metastases allowed provided patients are asymptomatic after cranial irradiation completed at least 4 weeks ago



  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No history, signs, or symptoms of clinically active interstitial lung disease

    • Patients with chronic, stable, asymptomatic radiographic changes are eligible


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
  • No other malignant disease within the past 5 years except basal cell skin cancer or adequately treated superficial carcinoma of the cervix


Biologic therapy

  • No concurrent immunotherapy


  • See Disease Characteristics
  • Recovered from prior chemotherapy (alopecia allowed)
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified


  • See Disease Characteristics


  • Not specified


  • No prior epidermal growth factor receptor inhibitors
  • No concurrent administration of any of the following drugs:

    • Phenytoin
    • Carbamazepine
    • Rifampin
    • Phenobarbital
    • Hypericum perforatum (St. John's wort)
  • No other concurrent anticancer therapy
  • No other concurrent experimental drugs

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): NCT00091156

Ziekenhuis Netwerk Antwerpen Middelheim
Antwerpen, Belgium, B-2020
Ghent University
Ghent, Belgium, B-9000
CHR - Clinique Saint Joseph - Hopital de Warqueguies
Mons, Belgium, B-7000
Clinique Sainte Elisabeth
Namur, Belgium, 5000
Bank Of Cyprus Oncology Centre
Nicosia, Cyprus, 2006 Strovolos
National Cancer Institute of Egypt
Cairo, Egypt
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24100
Ospedale Santa Croce
Cuneo, Italy, 12100
Universita di Ferrara
Ferrara, Italy, 44100
Presidio Ospedaliero di Livorno
Livorno, Italy, 57100
Ospedale Luigi Sacco
Milan, Italy, 20157
Ospedale Niguarda Ca'Granda
Milan, Italy, 20162
Azienda Ospedaliera - Universitaria di Modena
Modena, Italy, 41100
Azienda Ospedaliera Maggiore Della Carita
Novara, Italy, 28100
Azienda Ospedale S. Luigi at University of Torino
Orbassano, Italy, 10043
Azienda Ospedaliera Policlinico Paolo Giaccone
Palermo, Italy, 90127
Azienda Ospedaliera Di Parma
Parma, Italy, 43100
Azienda Ospedaliera "Santa Maria Degli Angeli"
Pordenone, Italy, 33170
Ospedale Sta. Maria Delle Croci
Ravenna, Italy, 48100
Arcispedale S. Maria Nuova
Reggio Emilia, Italy, 42100
Azienda Ospedaliera S. Camillo-Forlanini
Rome, Italy, 00152
Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
Ospedale Civile Maggiore - Borgo Trento
Verona, Italy, 37126
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands, 5211 NL
Rijnstate Hospital
Arnhem, Netherlands, 6800 TA
Kennemer Gasthuis - Locatie EG
Haarlem, Netherlands, 2000
Leiden University Medical Center
Leiden, Netherlands, 2300 RC
St. Franciscus Gasthuis
Rotterdam, Netherlands, 3045 PM
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Jan P. Van Meerbeeck, MD, PhD Universitair Ziekenhuis Gent

Publications of Results:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00091156     History of Changes
Other Study ID Numbers: EORTC-08021
2004-001331-36 ( EudraCT Number )
First Posted: September 8, 2004    Key Record Dates
Last Update Posted: July 16, 2012
Last Verified: July 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action