Ignite Creation Date:
2024-07-17 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496048
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
Lurbinectedin or in Combination With Irinotecan Versus Topotecan in Patients With Relapsed SCLC
Sponsor:
Luye Pharma Group Ltd
Organization:
Luye Pharma Group Ltd
Study Overview
Official Title:
A Phase III Multicenter Randomized Open-label Study of Lurbinectedin as Monotherapy or in Combination With Irinotecan Versus Topotecan in Patients With Relapsed Small-cell Lung Cancer SCLC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multicenter open-label randomized controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of Lurbinectedin monotherapy or Lurbinectedin Irinotecan combined therapy versus Topotecan comparator in Small-cell Lung Cancer SCLC patients who failed one prior platinum-containing line
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None