NCT05170581

Clinical Study of Sintilimab Combined With Chemotherapy in Neoadjuvant Treatment of Non-small Cell Lung Cancer

Efficacy and Safety of Sintilimab Combined With Platinum-containing Chemotherapy in Neoadjuvant Treatment of Resectable Stage ⅡB～ⅢA Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The Second Affiliated Hospital of Shandong First Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

By exploring the feasibility, effectiveness and safety of neoadjuvant therapy with Sintilimab combined with platinum-containing chemotherapy in patients with resectable Stage ⅡB-ⅢA NSCLC, we will provide new treatment options and strategies for stage ⅡB-ⅢA NSCLC.

Detailed description

The distant recurrence rate after radical surgery for early and partial locally advanced NSCLC is high, while the benefit degree of neoadjuvant chemotherapy is not satisfactory. The purpose of this study is to explore the feasibility, effectiveness and safety of neoadjuvant therapy with Sintilimab combined with platinum-containing chemotherapy in patients with resectable Stage ⅡB-ⅢA NSCLC. In addition to exploring the advantages of clinical efficacy of combination therapy, the analysis of biomolecular markers will be used to further understand the effects of combination therapy mode on immune activation and tumor immune microenvironment, and to explore potential biomarkers for predicting treatment response.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Sintilimab Combined with Platinum-containing Chemotherapy	Admininster Sintilimab and platinum-containing chemotherapy in neoadjuvant treatment of resectable stage ⅡB～ⅢA Non-small Cell Lung Cancer

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2021-12-28
• Last updated: 2021-12-28

Locations

1 site across 1 country: China