A clinical study of a monoclonal antibody Plus Whole-Brain Radiation Therapy (WBRT) Compared with WBRT Alone in Patients with Brain Metastases from Non Small Cell Lung Cancer

Phase 2

Registration Number: CTRI/2010/091/000344

Lead Sponsor: Biocon India Limited on behalf of YM Biosciences Inc., Ontario, Canada.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Other (Terminated)

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

Providing a written informed consent
2.Age >18 years
3.Histologic or cytologic confirmed diagnosis of NSCLC of any epithelial type (squamous, adenocarcinoma, large cell, or other)
4.At least one newly diagnosed measurable metastatic lesion from NSCLC in
the brain not suitable for surgical resection
5.Patient with initial diagnosis of brain metastases by image, within 8 weeks
of registration
6.KPS >70

Exclusion Criteria

1. Previous WBRT
2. Brain metastases resection with no other measurable lesion remaining
3. Extracranial metastases in 2 organs
4. Known leptomeningeal or subarachnoid spread
5. Plan to use radiosurgery or radiation boost after completion of WBRT
6. Plan to use chemotherapy or any other antineoplastic modality during WBRT
7. Previous use of an anti-EGFR drug (e.g. Tarceva, Erbitux etc.)
8. Patients receiving any other investigational agents
9. Presence of known seropositive HIV,
10.Severe co morbidities or other malignant neoplasm within the past 5 years (except adequately treated basal- or squamous-cell carcinoma of skin and in situ carcinoma of the uterine cervix)
11. Hypersensitivity or allergy to the drugs to be administered in this study
12. Inability or unwillingness to complete the required assessments

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is to assess the efficacy of Nimotuzumab in combination with WBRT. The primary endpoint is intracranial disease progression over 6 months.Timepoint: 6 months

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints are overall survival (OS); progression of intracranial disease at 2, 4 and 6 months; time to neurologic progression (TNP) or death with evidence of neurologic progression; OS rate at 6 months; time to intracranial disease progression; and time to overall progression.<br>Tissue samples and serum will be collected for future correlative studies.<br>Timepoint: 6 months