drugset / Trial / NCT00369447

A Study of Nimotuzumab in Combination With External Radiotherapy in Non-Small Cell Lung Cancer

NCT00369447

Phase 1/2 Terminated 52 enrolled YM BioSciences CIMYM BioSciences · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a Phase I-II study designed to investigate nimotuzumab (TheraCIM h-R3) in combination with external radiation in patients with non-small cell lung cancer. The purpose of the Phase I portion 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 and to select the optimal dose for the Phase II component of the study. The primary objective for the Phase II portion of the study is to examine the efficacy of this combination treatment. The Phase I component of this study has been completed. The Phase II is now closed to recruitment.

Timeline

Start
2009-03
Primary completion
2011-06
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Nimotuzumab Monoclonal antibody 200 mg