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

Project Data

Resource name Description