Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05891080
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-06
First Post:
2023-05-22
Brief Title:
Neoadjuvant Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy for Resectable or Potentially Resectable Stage III Non-small Cell Lung Cancer A Randomised Controlled Open-label 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 Platinum-based Doublet Chemotherapy for Resectable or Potentially Resectable Stage III Non-small Cell Lung Cancer A Randomised Controlled Open-label Phase 2 Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
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:
For stage III non-small cell lung cancer NSCLC neoadjuvant chemotherapy plus PD-1 antibody is recommended However most patients could not achieve complete pathological response CPR New immunotherapeutic strategy is needed to achieve higher CPR rate JS004 is a new antibody targeting B and T lymphocyte attenuator BTLA which restrains the function of immune cells and leads to immune escape of tumor cells The combination of PD-1 antibody and BTLA antibody has shown good therapeutic effect in solid tumors This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 plus chemotherapy in stage III NSCLC
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