A Randomized, Phase II, Double-Blind Study of Nimotuzumab Plus Whole-Brain Radiation Therapy (WBRT) Compared with WBRT Alone in Patients with Brain Metastases from Non-Small Cell Lung Cancer

• Conditions: Brain metastases from Non-Small Cell Lung Cancer (NSCLC)

• Registration Number: EUCTR2010-019637-96-DE
• Lead Sponsor: YMBiosciences INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Providing written informed consent
Age >|18 years
hystologic or cytologic confirmed diagnoses of NSCLC of any epithelial type
At least one newly diagnosed measurable metastatic lesion from NSCLC in the brain not suitable for surgical resection
Patient had initial diagnosis of brain metastases by image, within 8 weeks of registration
Women of childbearing potential and men must agree to use adequate contraception
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy, lactation or parturition within the previous 30 days
Previous WBRT
Brain metastases resection with no other measurable lesion remaining
Extracranial metastases in >| 2 organs
Known leptomeningeal or subarachnoid spread
Plan to use radiosurgery or radiation boost after completion of WBRT
Plan to use chemotherapy or any other antineoplastic modality during WBRT
Previous use of an anti-EGFR drug (e.g. Tarceva, Erbitux etc.)
Patients receiving any other investigational agents

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified