NCT06375109

PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage SCLC

PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage Small Cell Lung Cancer: an Open-label, Non-randomized Controlled, Phase II, Single-center Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Beijing Chest Hospital, Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, non-randomized, controlled, single-center, phase II study to compare the efficacy and safety of neoadjuvant PD-L1/PD-1 inhibitor + chemotherapy (carboplatin/cisplatin + etoposide) with chemotherapy (carboplatin/cisplatin + etoposide) alone followed by radical surgery and adjuvant treatment as perioperative therapy in patients with limited-stage SCLC.

Conditions

• Limited-stage Small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab	administered via Intravenous (IV) injection
DRUG	Carboplatin injection	administered via IV injection
DRUG	Cisplatin injection	administered via IV injection
DRUG	Etoposide injection	administered via IV injection

Timeline

• Start date: 2024-04-16
• Primary completion: 2027-04-15
• Completion: 2029-04-15
• First posted: 2024-04-19
• Last updated: 2024-04-19