Iressa vs Placebo as Maintenance Therapy in Locally Advanced 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: NCT00234468
Recruitment Status : Terminated (Closed due to insufficient recruitment)
First Posted : October 7, 2005
Last Update Posted : May 20, 2011
Information provided by:

October 5, 2005
October 7, 2005
May 20, 2011
January 2004
Not Provided
Time to progression (2 years after Last patient in)
Same as current
Complete list of historical versions of study NCT00234468 on Archive Site
  • Modalities of relapse or progression (2 years after Last patient in)
  • Overall survival (2 years after Last patient in)
Same as current
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Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC
A Phase III, Double-Blind, Randomised Study Comparing ZD1839 (IressaTM) Versus Placebo As Maintenance Therapy In Subjects With Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) After Combined Modality Therapy
The aim of the study if to determine if Iressa can prolong the period of time without any disease worsening (Time to progression) in patients previously treated with combined therapy such as surgery and chemotherapy with or without radiotherapy or chemotherapy and radiotherapy
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Non Small Cell Lung Carcinoma
Drug: Iressa (Gefitinib)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2007
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Inclusion Criteria:

  • Histologically Confirmed Non Small Cell Lung Cancer.
  • Locally advanced disease previously treated with combined therapy (chemotherapy and surgery with or without radiotherapy, or chemotherapy and radiotherapy).
  • Chemotherapy with regimens containing cisplatin or carboplatin is mandatory
  • Response to combined therapy

Exclusion Criteria:

  • No previous treatment with ZD1839 or any other EGFR-targeted therapy
  • No progressive disease after combined therapy for locally advanced NSCLC
  • No presence of metastatic disease
  • No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  • Any unresolved chronic toxicity from previous anticancer therapy.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Principal Investigator: Lucio Crino, MD Bologna Italy
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP