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Iressa in Poor Performance Status Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer

S

SCRI Development Innovations

Status and phase

Completed
Phase 2

Conditions

Lung Cancer

Treatments

Drug: ZD1839

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00193336
SCRI LUN 71
IRUSIRES0002

Details and patient eligibility

About

Because of the demonstrated single agent activity and excellent tolerability in patients with refractory non-small cell lung cancer, ZD1839 may be of benefit in the first-line treatment of patients with advanced non-small cell lung cancer who have poor performance status. In this phase II trial, we will investigate the single agent activity of first-line ZD1839 in patients with advanced non-small cell lung cancer with poor performance status

Full description

Upon determination of eligibility, patients will be receive:

  • ZD1839

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

To be included in this study, you must meet the following criteria:

  • Biopsy proven non-small cell lung cancer
  • Recurrent non-small cell lung cancer after previous surgery or radiation
  • Advanced disease (stage IIIb or IV)
  • No previous chemotherapy or biological therapy
  • Require significant assistance with activities of daily living
  • Measurable disease
  • Adequate bone marrow, liver and kidney function
  • Give written informed consent

Exclusion criteria

You cannot participate in this study if any of the following apply to you:

  • Brain metastasis
  • Meningeal metastasis
  • Other uncontrolled malignancies
  • Women pregnant or lactating
  • No measurable disease outside previous radiation therapy field

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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