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An Expanded Access Clinical Program With ZD1839 (IRESSA®) for Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Phase 3
18 Years
Not Enrolling
Carcinoma, Non-small-cell Lung, Metastases, Neoplasm

Thank you

Trial Information

An Expanded Access Clinical Program With ZD1839 (IRESSA®) for Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Inclusion Criteria

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

- 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).

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Iressa Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2000

Completion Date:

October 2003

Related Keywords:

  • Carcinoma
  • Non-Small-Cell Lung
  • Metastases
  • Neoplasm
  • Locally advanced and/or metastatic non-operable
  • non-small cell lung cancer (stage III or IV)
  • patients who have failed standard therapy.
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Neoplasm Metastasis



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