Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505837
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-19
Brief Title:
JS001sc or JS001 Plus Chemotherapy is Indicated for Relapsed or Metastatic First-Line Non-Squamous Non Small Cell Lung CancerNSCLC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Open-Label Randomized Phase III Clinical Study Comparing the Pharmacokinetic Profile Efficacy and Safety of JS001sc and JS001 in Combination With Standard Chemotherapy as First-Line Treatment for Recurrent Metastatic Non-Squamous Non Small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter open-Lable randomized phase III clinical study to compare the pharmacokinetic profile efficacy and safety of Toripalimab injection subcutaneous JS001sc and Toripalimab injection JS001 in combination with standard chemotherapy as first-line treatment for recurrent or metastatic Non-Squamous Non small cell lung cancer
Detailed Description:
A randomized open-labelmulticenter phase III clinical study was designed to enroll 356 participants with recurrent or metastatic Non-Squamous Non small cell lung cancer without EGFR sensitive mutations or ALK fusion They will be randomly assigned in a 11 ratio to one of two treatment groupsGroup A JS001sc platinum-based chemotherapyJS001sc 360 mg was administered subcutaneously SC once every 3 weeks Q3WChemotherapy pemetrexed carboplatincisplatin Q3W up to 4 cycles non-progressive subjects pemetrexed monotherapy maintenance therapy Group B JS001 platinum-based chemotherapyJS001 240 mg IV Q3WChemotherapy pemetrexed carboplatincisplatin Q3W up to 4 cycles non-progressive subjects pemetrexed monotherapy maintenance therapy Both groups were treated until treatment termination criteria were met
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None