None listed
Conditions
Interventions
Intervention1: Nimotuzumab: Nimotuzumab 200 mg will be administered by IV route in Isotonic saline solution over 30 minutes weekly during radiotherapy
Control Intervention1: WBRT: Radiotherpy will con
Sponsors
Biocon India Limited on behalf of YM Biosciences Inc., Ontario, Canada.
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. Tissue samples and serum will be collected for future correlative studies. Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr. Anand Eshwariah
Clinigene International Limited
Outcome results
None listed