Iressa in the Treatment of Brain Metastases From Non Small Cell Lung Cancer

A Phase II, Multicentre, Non-Comparative, Open-Label Study To Evaluate The Efficacy And Tolerability Of ZD1839 (Iressa™) In Asymptomatic Radio-Naive Patients With Brain Metastases From Non-Small Cell Lung Carcinoma (NSCLC) Who Have Relapsed Following Prior Chemotherapy

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00234442

Enrollment

Registered

2005-10-07

Start date

2004-07-31

Completion date

2006-02-28

Last updated

2009-06-30

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

Conditions

Brain Neoplasms, Non Small Cell Lung Cancer

Keywords

Non symptomatic brain metastases, Iressa

Brief summary

The aim of the study is to determine if Iressa is effective in the treatment of Brain metastases from NCSLC

Interventions

DRUGIressa (Gefitinib)

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

* Radiologically confirmed brain metastases from Non Small Cell Lung Cancer * No symptoms due to brain metastases * No previous radiotherapy treatment for the Brain metastases

Exclusion criteria

* No prior chemotherapy * 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 evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)

Design outcomes

Primary

Measure	Time frame
Disease control rate (complete response, partial response and stable disease)	—

Secondary

Measure	Time frame
Duration of response	—
Time to progression	—
Overall Survival	—

Countries

Italy

Outcome results

None listed

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