Temozolomide for Treatment of Brain Metastases From Non-Small Cell Lung Cancer (Study P03247)

A Randomized, Open-Label Phase 2 Study of Temozolomide Added to Whole Brain Radiation Therapy Versus Whole Brain Radiation Therapy Alone for the Treatment of Brain Metastasis From Non-Small Cell Lung Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00076856

Enrollment

Registered

2004-02-06

Start date

2004-03-31

Completion date

2006-03-31

Last updated

2017-05-09

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

Conditions

Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

Brief summary

The purpose of this study is to demonstrate improvement in overall survival for the combination of whole brain radiation therapy (WBRT) plus temozolomide (TMZ) versus WBRT alone. Secondary objective is to demonstrate an improvement in the time to radiological CNS progression with the addition of TMZ to WBRT.

Interventions

DRUGTemozolomide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age greater than or equal to 18 * Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) * At least one brain metastasis diagnosed within 30 days of randomization * Brain metastases must not have been previously treated with WBRT or radiosurgery * No more than 2 sites of extracranial metastases * May have received prior radiation therapy to the primary tumor and/or systemic metastatic sites * Meets protocol requirements for specified laboratory values. * Written informed consent and cooperation of patient * Appropriate use of effective contraception if of childbearing potential. * Karnofsky Performance Status KPS greater than 70 * Score less than 2 on all criteria of the Comprehensive Neurological Outcome Scale (CNOS)

Design outcomes

Primary

Measure	Time frame
Overall Survival	—

Secondary

Measure	Time frame
Time to radiological CNS progression	—

Outcome results

None listed

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