drugset / Trial / NCT05465733
First-line Replacement Maintenance of Envafolimab in Advanced NSCLC
NaSingle-groupOpen-labelTreatment
Summary
This study is a single-center, prospective, single-arm phase II clinical study. For newly-treated patients with advanced NSCLC with negative driver gene and positive PD-L1 expression, those patients who did not progress after 4-6 cycles of PD-1 or PD-1 combined with chemotherapy standard treatment, after signing the informed consent form, were screened to meet the criteria for inclusion and exclusion. Standard, will receive Envafolimab combined with chemotherapy/Envafolimab single-agent first-line maintenance therapy until disease progression, withdrawal of informed consent, initiation of other anti-tumor therapy, death, or other protocol-specified conditions that should be discontinued Circumstances, whichever occurs first.
Timeline
- Start
- 2022-08-01
- Primary completion
- 2025-06-30
- Completion
- 2025-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Envafolimab | Monoclonal antibody | 300 mg | — |
| Background | Pemetrexed | Small molecule | — | — |