Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449209
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-03
Brief Title:
Safety Preliminary Effectiveness of BNT327 an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Sponsor:
BioNTech SE
Organization:
BioNTech SE
Study Overview
Official Title:
A Phase II Multi-site Open-label Parallel Group Trial of BNT327 in Combination With Chemotherapy for Participants With Untreated Extensive-stage Small-cell Lung Cancer and Participants With Previously Treated Small-cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
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:
This is a Phase II multi-site open-label parallel group study in participants with untreated extended-stage small-cell lung cancer ES-SCLC Cohort 1 or small-cell lung cancer SCLC progressed on first- or second-line treatment Cohort 2 and Cohort 3
Detailed Description:
Patients will be treated until disease progression intolerable toxicity patient withdrawal study termination or up to 2 years whichever occurs first
Participants will be assigned to either Cohort 1 or Cohort 2Cohort 3 based on their disease type ie untreated ES-SCLC for Cohort 1 and SCLC progressed on first- or second-line treatment for Cohort 2 and Cohort 3 Assignment to either Cohort 2 or Cohort 3 will be the investigators choice
Participants will be assigned to either Cohort 1 or Cohort 2Cohort 3 based on their disease type ie untreated ES-SCLC for Cohort 1 and SCLC progressed on first- or second-line treatment for Cohort 2 and Cohort 3 Assignment to either Cohort 2 or Cohort 3 will be the investigators choice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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