Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06095583
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-10-09
Brief Title:
Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer LS-SCLC
Sponsor:
Shanghai Junshi Bioscience Co Ltd
Organization:
Shanghai Junshi Bioscience Co Ltd
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multi-Regional Phase III Clinical Study of Toripalimab Alone or in Combination With Tifcemalimab JS004TAB004 as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Disease Progression Following Chemoradiotherapy
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The Study is a Phase 3 randomized three-arm double-blind placebo-controlled multi-regional clinical research study to evaluate the safety and efficacy use of toripalimab alone or in combination with tifcemalimab as consolidation therapy in patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy
Tifcemalimab is a monoclonal antibody against B and T lymphocyte attenuator BTLA Toripalimab is a monoclonal antibody against programmed death protein-1 PD-1 Neither drug is approved for treatment of This combination regimen is investigational in limited stage-small cell lung cancer in any country
Tifcemalimab is a monoclonal antibody against B and T lymphocyte attenuator BTLA Toripalimab is a monoclonal antibody against programmed death protein-1 PD-1 Neither drug is approved for treatment of This combination regimen is investigational in limited stage-small cell lung cancer in any country
Detailed Description:
None
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