Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06256237
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-02-05
Brief Title:
Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum Chemotherapy for Limited-stage Small Cell Lung Cancer A Phase 2 Trial
Sponsor:
Shanghai Pulmonary Hospital Shanghai China
Organization:
Shanghai Pulmonary Hospital Shanghai China
Study Overview
Official Title:
Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum Chemotherapy for Limited-stage Small Cell Lung Cancer A Single-arm Phase 2 Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
For limited-stage small cell lung cancer SCLC neoadjuvant chemotherapy plus PD-1 antibody is recommended However most patients cannot achieve a complete pathological response CPR A new immunotherapeutic strategy is needed to achieve a higher CPR rate JS004 is a new antibody targeting B and T lymphocyte attenuator BTLA which restrains immune cells39 function and leads to immune escape of tumor cells The combination of PD-1 and BTLA antibodies has shown a good therapeutic effect in solid tumors This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 plus etoposide and platinum Chemotherapy in limited-stage SCLC
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