Iressa Expanded Access Program (EAP)

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: May 2, 2002
Last updated: January 3, 2013
Last verified: January 2013
A program for patients with non small cell lung cancer who may benefit from Iressa, but cannot enter another clinical trial due to them not being eligible, or for whom no trials are available.

Condition Intervention Phase
Non-small-cell Lung
Drug: ZD1839 (Gefitinib)
Phase 3

AstraZeneca has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Expanded Access Clinical Program With ZD1839 (IRESSA®) for Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Study Start Date: August 2000
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ZD1839 (Gefitinib)
    Other Name: Iressa

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria

For inclusion in this trial, patients must fulfill all of the following criteria:

  • previous documented histologically or cytologically confirmed non-small cell lung cancer;
  • locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV)patients who have received at least one course of standard systemic chemotherapy or radiation therapy or are ineligible for chemotherapy or radiotherapy or are ineligible or not a candidate for enrollment on another ZD1839 trial or who, in the Investigator's opinion, are not medically suitable for chemotherapy.
  • age 18 years or older;
  • written informed consent to participate in the trial.

Exclusion Criteria

Any of the following will exclude a patient from entering the trial:

  • receiving concurrent radiotherapy, chemotherapy, or other systemic anti-cancer medication or any other investigational agent. * Non-cytotoxic or hormonal therapies for the adjuvant treatment of cancer or for previously treated cancers may be allowed per AstraZeneca permission;
  • patients eligible for or previously enrolled on a ZD1839 blinded clinical trial protocol. Patients eligible for or previously enrolled on an open-label or unblinded ZD1839 clinical trial may be considered for acceptance into the Expanded Access Program with AstraZeneca permission;
  • having other active malignancies;
  • incomplete healing from previous oncologic or other major surgery;
  • evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial;
  • pregnancy or breast feeding (women of child-bearing potential).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00034879

  Show 627 Study Locations
Sponsors and Collaborators
Study Director: Iressa Medical Science Director, MD AstraZeneca
  More Information

No publications provided Identifier: NCT00034879     History of Changes
Other Study ID Numbers: 1839IL/0050 
Study First Received: May 2, 2002
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Locally advanced and/or metastatic non-operable
non-small cell lung cancer (stage III or IV)
patients who have failed standard therapy.

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms processed this record on February 04, 2016