A Randomized, Double-Blind, Multicenter, Phase III Study to Compare Clinical Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination with Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Patients with ES-SCLC
| Title | A Randomized, Double-Blind, Multicenter, Phase III Study to Compare Clinical Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination with Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Patients with ES-SCLC |
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| 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. |
| Organism | Homo sapiens |
| Data Type | Other Type of Clinical information |
| Data Accessibility | Open-access |
| BioProject | PRJCA014383 |
| Release Date | 2023-01-13 |
| Submitter | nan zhao (1165095416@qq.com) |
| Organization | Jilin Cancer Hospital |
| Submission Date | 2023-01-12 |
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| File ID | File Title | Number/Samples | File Type | File Size | File Suffix | Download Times | Download |
|---|---|---|---|---|---|---|---|
| OMIX002797-01 | PK and ADA and PD-L1 | 25 | Other Type of Clinical information | 2.0 MB | zip | 0 |