NCT04542369

Pilot Study of PD-1inhibitor (Tislelizumab) Plus Chemotherapy as Neoadjuvant Therapy for Limited-Stage Small-Cell Lung Cancer

Neoadjuvant PD-1 Inhibitor (Tislelizumab) Plus Chemotherapy in Patients With Limited-stage Small-cell Lung Cancer: an Open-lable, Single-arm, Phase 2 Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, non-randomized, open-label, single-center study to evaluate the efficacy and safety of neoadjuvant PD-1 inhibitor (Tislelizumab) + chemotherapy (cisplatin/carboplatin + etoposide) followed by radical surgery and adjuvant Tislelizumab immunotherapy as first-line treatment in patients limited-stage SCLC.

Conditions

• Small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab (BGB-A317) Plus Chemotherapy (Cisplatin/Carboplatin and Etoposide)	Inductive/neoadjuvant therapy: Tislelizumab + EP Maintenance/adjuvant therapy: Tislelizumab + EP

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-12-31
• Completion: 2025-11-30
• First posted: 2020-09-09
• Last updated: 2023-05-03

Locations

1 site across 1 country: China