Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460551
Status:
TERMINATED
Last Update Posted:
2011-12-06
First Post:
2007-04-12
Brief Title:
Zalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer
Sponsor:
Genmab
Organization:
Genmab
Study Overview
Official Title:
A Randomized Open-label Multi-center Trial Investigating Zalutumumab a Human Monoclonal Anti-EGF Receptor Antibody in Combination With Chemo-Radiation in Stage IIIA-IIIB Non Small Cell Lung Cancer Patients
Status:
TERMINATED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to considerations regarding the appropriate therapeutic regimen for these patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to investigate if treatment with zalutumumab in combination with chemotherapy and radiotherapy chemo-radiation will lead to a prolonged life in patients with lung cancer compared to patients treated with chemo-radiation alone
Detailed Description:
Originally the study was planned as Part 1A Part 1B and Part 2 Part 1A was one arm with zalatumumab fixed dose 8 mgkg Part 1B was planned as zalutumumab dose-titration and Part 2 adding a comparator The trial was prematurely closed for enrolment when patients had only been enrolled in Part 1A due to published results showing increased toxicity from induction chemotherapy without any survival benefit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None