drugset / Trial / NCT05346952
A Study of TQB2450 Injection Plus Chemotherapy Followed by TQB2450 Plus Anlotinib Versus Tislelizumab Plus Chemotherapy Followed by Tislelizumab in the Treatment of First-line Non-squamous Non-small Cell Lung Cancer(NSCLC).
RandomizedParallel-groupOpen-labelTreatment
Summary
This is Phase 3, randomized, open-label, parallel controlled study designed to compare the efficacy and safety of TQB2450 in combination with platinum-containing chemotherapy followed by TQB2450 plus Anlotinib versus tislelizumab in combination with platinum-containing chemotherapy followed by tislelizumab in locally advanced (stage ⅢB/ⅢC), metastatic or recurrent ( Stage IV) non-squamous NSCLC cancer. The primary endpoint is Progression Free Survival (PFS) assessed by IRC.
Timeline
- Start
- 2022-01-25
- Primary completion
- 2023-12
- Completion
- 2023-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Benmelstobart | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | Catequentinib | Small molecule | 10 mg | Oral |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |