Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC

May 19, 2011 updated by: AstraZeneca

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

490

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Avellino, Italy
        • Research Site
      • Bergamo, Italy
        • Research Site
      • Bologna, Italy
        • Research Site
      • Cagliari, Italy
        • Research Site
      • Campobasso, Italy
        • Research Site
      • Catania, Italy
        • Research Site
      • Catanzaro, Italy
        • Research Site
      • Chieti, Italy
        • Research Site
      • Cosenza, Italy
        • Research Site
      • Della Fratte, Italy
        • Research Site
      • Emilia, Italy
        • Research Site
      • Fano, Italy
        • Research Site
      • Firenze, Italy
        • Research Site
      • Forli, Italy
        • Research Site
      • Frattamaggiore, Italy
        • Research Site
      • Livorno, Italy
        • Research Site
      • Messina, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Novara, Italy
        • Research Site
      • Orbassano, Italy
        • Research Site
      • Padova, Italy
        • Research Site
      • Palermo, Italy
        • Research Site
      • Pavia, Italy
        • Research Site
      • Potenza, Italy
        • Research Site
      • Ravenna, Italy
        • Research Site
      • Rimini, Italy
        • Research Site
      • Roma, Italy
        • Research Site
      • San Giovanni Rotondo, Italy
        • Research Site
      • Sassari, Italy
        • Research Site
      • Taormina, Italy
        • Research Site
      • Venezia-Mestre, Italy
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to progression (2 years after Last patient in)

Secondary Outcome Measures

Outcome Measure
Modalities of relapse or progression (2 years after Last patient in)
Overall survival (2 years after Last patient in)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Lucio Crino, MD, Bologna Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

October 5, 2005

First Submitted That Met QC Criteria

October 5, 2005

First Posted (Estimate)

October 7, 2005

Study Record Updates

Last Update Posted (Estimate)

May 20, 2011

Last Update Submitted That Met QC Criteria

May 19, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1839IL/0126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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