drugset / Trial / NCT05465733

First-line Replacement Maintenance of Envafolimab in Advanced NSCLC

NCT05465733

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

EvaluationDrugModalityDoseRoute
Subject Envafolimab Monoclonal antibody 300 mg
Background Pemetrexed Small molecule