NCT05448781

Recombinant Human Angioendostatin /PD-1 Mab Combined With First-line Chemotherapy in the Treatment of Driver Gene Negative Advanced NSCLC

a Clinical Trial Phase II Prospective, Single-arm Study of Recombinant Human Angioendostatin /PD-1 Mab Combined With First-line Chemotherapy in the Treatment of Driver Gene Negative Advanced Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of recombinant human endostatin /PD-1 mab combined with first-line chemotherapy in the treatment of driver gene negative advanced non-small cell lung cancer.

Detailed description

This study is planned to enroll 38 eligible patients in China. Patients who fulfill all the inclusion criteria and none of the exclusion criteria will receive 4-6 cycles of endostatin combined with PD-1 antibody and platinum-containing two-drug chemotherapy.The efficacy of first-line treatment was evaluated every 6 weeks (2 cycles, 42 days). Patients with disease control (CR+ PR+SD) and tolerable adverse reactions were treated for 4-6 cycles,The maintenance treatment phase was continuous treatment with Endu combined with PD-1 antibody, and the efficacy was evaluated every 9 weeks until the end of the study when the investigator considered that the patient was not suitable for continued medication or the efficacy evaluation was disease progression (PD). No other antitumor therapy can be performed during the treatment period. Follow-up of survival was once every 3 months.

Conditions

• Non Small Cell Lung Cancer
• Endostatin

Interventions

Type	Name	Description
DRUG	Endostatin	Eligible patients with advanced NSCLC were treated with endostatin combined with Tirelizumab and platinum-containing two-drug chemotherapy.26 cases of non-squamous cell carcinoma were treated with endostatin combined with Tirelizumab and Pemetrexed+Carboplatin. and 12 cases of squamous cell carcinoma were treated with endostatin combined with Tirelizumab and Paclitaxel/Albumin paclitaxel+Carboplatin,The maintenance treatment phase was continuous treatment with Endu combined with Tirelizumab

Timeline

• Start date: 2022-07-20
• Primary completion: 2023-07-20
• Completion: 2023-12-20
• First posted: 2022-07-07
• Last updated: 2022-07-07

Locations

1 site across 1 country: China