A Phase I-II Clinical Study of Nimotuzumab (TheraCIM h-R3) in Combination With External Radiotherapy in Stage IIB, III and IV NSCLC
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Non-small-cell Lung Cancer
- Sponsor
- YM BioSciences
- Enrollment
- 52
- Locations
- 13
- Primary Endpoint
- Phase II: Overall survival
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Phase II: Overall survival
Time Frame: Every 8 weeks until disease progression
Secondary Outcomes
- 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)
- Local response rate(Every 8 weeks until disease progression)
- Progression-free survival(1 year)
- Phase II: Quality of life(At week 4, week 8, every 2 months thereafter)