Accession |
PRJCA014383 |
Title |
A Randomized, Double-blind, PlaceboControlled Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy (Carboplatin- Etoposide) in Patients with ES-SCLC |
Relevance |
Medical |
Data types |
PK and ADA and PD-L1 and MSITMB
|
Organisms |
Homo sapiens
|
Description |
PK and ADA samples of HLX10 or placebo are collected and sent to the central laboratory for evaluation. PK and ADA samples for HLX10 or placebo will be collected at the following time points:Within 7 days pre-dose in Cycle 1, within 3 days pre-dose in Cycles 2,4,6,8 and every 4 cycles thereafter,within 2 hours after the end of dosing in Cycles 1 and 8 of treatment period(for PK only),and at EOT visit and safety follow-up. |
Sample scope |
Multiisolate |
Release date |
2023-01-12 |
Grants |
Agency |
program |
Grant ID |
Grant title |
No funding support
|
|
|
|
|
Submitter |
zhao
nan (1165095416@qq.com)
|
Organization |
Jilin Cancer Hospital |
Submission date |
2023-01-12 |