NCT05203276

Envafolimab Combined With Endostar in the First-line Treatment of Advanced NSCLC

A Prospective, Multi-center, Single-arm Exploratory Clinical Study of Envafolimab Combined With Endostar in the First-line Treatment of Driver Gene-negative Advanced Non-small Cell Lung Cancer With PD-L1 Positive Expression

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The First People's Hospital of Lianyungang · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

To evaluate the efficacy and safety of envafolimab combined with endostar in the first-line treatment of advanced Non-small Cell Lung Cancer With PD-L1 positive expression

Detailed description

Endostar indication: ENDOSTAR + NP chemotherapy regimen is used to treat Stage III/IV NSCLC patients either untreated or pretreated. This indication is based on a completed multi-center Phase III clinical trial. Envafolimab indication: Envolimab is the world's first subcutaneous injection of PD-L1 monoclonal antibody.Suitable for adult patients with advanced solid tumors with unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects (dMMR).

Conditions

• Lung Neoplasms

Interventions

Type	Name	Description
DRUG	Envafolimab	300mg，SC，Q3W，d1
DRUG	Endostar	210mg，CIV，Q3W，d1-3

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-05-30
• Completion: 2024-06-30
• First posted: 2022-01-24
• Last updated: 2023-06-22

Locations

1 site across 1 country: China