Phase II Study in Patients With Recurrent Non-Small-Cell Lung Cancer
Phase 2
Completed
- Conditions
- Non-Small-Cell Lung Cancer
- Interventions
- Biological: Cetuximab
- Registration Number
- NCT00063388
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Determine tumor response rate and time to disease progression, survival and safety in total populations.
- Detailed Description
To determine the tumor response rate and time to disease progression, survival and safety in the EGFR-positive, EGFR-negative and total populations.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Cetuximab Cetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes).
- Primary Outcome Measures
Name Time Method The primary objective of this study was to determine the tumor response rate for single-agent cetuximab in EGFR+ subjects. Every 8 weeks
- Secondary Outcome Measures
Name Time Method Determine the tumor response rate in the total population and in EGFR- subjects Every 8 weeks Time to disease progression in the EGFR+ and total populations. Every 8 weeks Survival in the EGFR+ and total populations. Every 8 weeks Safety in the EGFR+ and total populations. Every 8 weeks
Trial Locations
- Locations (1)
ImClone Investigational Site
🇺🇸Saint Louis, Missouri, United States