drugset / Trial / NCT07109401

Perioperative Immunotherapy for Resectable Limited-Stage SCLC

NCT07109401 ↗

Phase 2 Recruiting 37 enrolled Fudan University
NaSingle-groupOpen-labelTreatment

Summary

For limited-stage small cell lung cancer (SCLC), surgical treatment is recommended for patients with T1-2N0M0 (I-IIA) by guidelines. However, whether perioperative immunotherapy extends radical surgery to stage IIB-IIIB patients with improved survival remains elusive. This is a phase II, single-arm study to evaluate the efficacy and safety of neoadjuvant Tislelizumab + chemotherapy (Cisplatin/Carboplatin + Etoposide) followed by radical surgery and adjuvant Tislelizumab ± chemotherapy for patients with limited-stage SCLC.

Timeline

Start
2025-03-01
Primary completion
2028-03-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 5 unknown —
Subject Carboplatin Small molecule 6 unknown —
Subject Cisplatin Other / unclassified 75 mg/m2 —
Subject Etoposide Small molecule 100 mg/m2 —
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous