Completed

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

What is being tested

Data Collection

Who is being recruted

Brain Diseases+16

+ Brain Neoplasms

+ Bronchial Neoplasms

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: March 2004

See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC

Last updated: January 18, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 31, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleA 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

NCT00076856

Principal SponsorMerck Sharp & Dohme LLC

Last updated: January 18, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

95 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesBrain NeoplasmsBronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungCentral Nervous System DiseasesLung DiseasesLung NeoplasmsNeoplasm MetastasisNeoplasmsNeoplasms by SiteNeoplastic ProcessesNervous System DiseasesNervous System NeoplasmsPathologic ProcessesRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsCentral Nervous System Neoplasms

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)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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CompletedNo study centers