A Phase I-II Clinical Study of Nimotuzumab (TheraCIM h-R3) in Combination With External Radiotherapy in Stage IIB, III and IV NSCLC
This is a randomized, double blind, multicenter Phase II study with Phase I lead-in.
Patients enrolled in this study will receive external radiotherapy with or without
nimotuzumab (TheraCIM h-R3). The objective of the Phase I component of the study is to
evaluate the safety and feasibility of the administration of nimotuzumab with palliative
radiation in patients who are unsuitable for radical therapy (curative intent
chemoradiation) and to select the optimal biologically effective dose (BED) for Phase II
component of the study. In the Phase II component, overall survival, local and systemic
response rates and quality of life will be evaluated inpatients treated with nimotuzumab in
combination with palliative radiation vs. radiation alone.
The Phase I component of this study has been completed. The Phase II is now closed to
recruitment.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Phase II: Overall survival
Every 8 weeks until disease progression
Yes
Gwyn Bebb, MD
Principal Investigator
Tom Baker Cancer Center
Canada: Health Canada
YMB1000-010
NCT00369447
March 2009
July 2011
Name | Location |
---|---|
Florida Cancer Institute - New Hope | New Port Richey, Florida 34655 |