NCT05243355

Envafolimab Combined With Chemotherapy and Recombinant Human Endostatin in the First-line Treatment of Sq-NSCLC

A Prospective, Single-arm, Phase II Study of Envafolimab Combined With Chemotherapy and Recombinant Human Endostatin in the First-line Treatment of Advanced (Stage IIIB-IV) Squamous Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single arm, multicenter phase II study aimed at evaluating the efficacy and safety of Envafolimab combined with standard platinum containing dual drug chemotherapy and Recombinant Human Endostatin in patients with advanced (stage IIIB-IV) squamous non-small cell lung cancer.

Conditions

• Squamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	"Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin"	Envafolimab: 300 mg，D1，Q3W,until PD or intolerable toxicity Chemotherapy: Paclitaxel / NAB-Paclitaxel, 175 / 260mg / m2, D1, Q3w; Cisplatin: 75mg / m2, 1-3 days, or carboplatin: AUC 5, D1, Q3w, 4-6 cycles in total. Recombinant Human Endostatin：210mg，CIV 72h，d1-3，Q3W，4-6 cycles in total.

Timeline

• Start date: 2021-12-03
• Primary completion: 2023-12-03
• Completion: 2024-12-03
• First posted: 2022-02-17
• Last updated: 2022-02-17

Locations

2 sites across 1 country: China