drugset / Trial / NCT06618391
Local Injection and Systemic Therapy in the Treatment of NSCLC.
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a prospective, exploratory Phase II clinical study aimed at evaluating the safety and efficacy of Envafolimab and recombinant human endostatin and Recombinant Human Adenovirus Type 5 Intratumor local injection combined with systemic therapy in patients with locally advanced or advanced non-small cell lung cancer(NSCLC).
Timeline
- Start
- 2024-10-08
- Primary completion
- 2026-03-02
- Completion
- 2026-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Endostar | Protein / enzyme biologic | 15 mg | Intravenous |
| Subject | Endostar | Protein / enzyme biologic | 210 mg | Intravenous |
| Subject | Envafolimab | Monoclonal antibody | 150 mg | Intrathecal |
| Subject | Envafolimab | Monoclonal antibody | 300 mg | Intrathecal |
| Subject | H101 | Other / unclassified | 1 ml | Intrathecal |
| Background | Docetaxel | Small molecule | 60 mg/m2 | Intravenous |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |