A Study of Nimotuzumab in Combination With External Radiotherapy in Non-Small Cell Lung Cancer
- Conditions
- Non-small-cell Lung Cancer
- Interventions
- Procedure: External radiotherapyBiological: nimotuzumab
- Registration Number
- NCT00369447
- Lead Sponsor
- YM BioSciences
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 52
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 nimotuzumab 200 mg dose 2 External radiotherapy - 1 External radiotherapy 200 mg dose 2 nimotuzumab -
- Primary Outcome Measures
Name Time Method Phase II: Overall survival Every 8 weeks until disease progression
- Secondary Outcome Measures
Name Time Method Local response rate Every 8 weeks until disease progression Progression-free survival 1 year Phase I: Biologically effective dose 2.5 Years Time to progression Every 8 weeks until disease progression Phase II: Overall response rate Every 8 weeks until disease progression Overall clinical benefit Every 8 weeks until disease progression Time to local progression Every 8 weeks until disease progression Local clinical benefit Every 8 weeks until disease progression Phase II: Quality of life At week 4, week 8, every 2 months thereafter
Trial Locations
- Locations (13)
The Ottawa Hospital Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Segal Cancer Center - Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Thunderbay Regional hospital Center
🇨🇦Thunderbay, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Tom Baker Cancer Center
🇨🇦Calgary, Alberta, Canada
Florida Cancer Institute - New Hope
🇺🇸New Port Richey, Florida, United States
Cancer Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
Dr. H. Bliss Murphy Cancer Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
London Regional Cancer Center
🇨🇦London, Ontario, Canada
Hopital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
National Cancer Center Singapore
🇸🇬Singapore, Singapore
Centre Hospitalier de L'Universite de Montreal - Hôpital Notre Dame
🇨🇦Montreal, Quebec, Canada
Hotel Dieu Hospital
🇨🇦Quebec City, Quebec, Canada