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

Phase II Trial of Single Agent ZD1839 (Iressa) in Poor Performance Status Patients With Previously Untreated Advanced Non-Small Cell Lung Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193336

Enrollment

Registered

2005-09-19

Start date

2003-03-31

Completion date

2005-09-30

Last updated

2011-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

NSCLC Lung Cancer, Non Small Cell Lung Cancer

Brief summary

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

Detailed description

Upon determination of eligibility, patients will be receive: * ZD1839

Interventions

DRUGZD1839

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
Overall response rate	—

Secondary

Measure	Time frame
Overall toxicity	—
Quality of life	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026