Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-24 @ 4:48 PM
Study NCT ID:
NCT05844150
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-12
First Post:
2023-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC
Sponsor:
Biotheus Inc.
Organization:
Study Overview
Official Title:
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of PM8002 in Combination With Etoposide and Platinum in First-line Treatment of Extensive-Stage Small Cell Lung Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
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:
PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study to evaluate the efficacy and safety of PM8002 in combination with etoposide and platinum in first-line treatment of extensive-stage small cell lung cancer
Detailed Description:
The study is divided into two parts.
The first part is single-arm study, 50 participants were enrolled as of 21 Nov 2023，and recruitment was completed.
The second part is randomized, double-blind study, active controlled design , which will be integrated to another global III study （NCT06712355）.
The first part is single-arm study, 50 participants were enrolled as of 21 Nov 2023，and recruitment was completed.
The second part is randomized, double-blind study, active controlled design , which will be integrated to another global III study （NCT06712355）.
Study Oversight
Has Oversight DMC:
False
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?: