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RECRUITING
NCT07109401
PHASE2

Perioperative Immunotherapy for Resectable Limited-Stage SCLC

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

Official title: Perioperative Tislelizumab for Resectable Small Cell Lung Cancer in Stage IIB-IIIB: A Phase 2 Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

37

Start Date

2025-03-01

Completion Date

2028-12-31

Last Updated

2025-08-07

Healthy Volunteers

No

Interventions

DRUG

Tislelizumab (BGB-A317) Plus Chemotherapy (Cisplatin/Carboplatin and Etoposide)

Neoadjuvant therapy: Tislelizumab + Cisplatin or Carboplatin + Etoposide; Adjuvant therapy: Tislelizumab + Cisplatin or Carboplatin + Etoposide (the total cycle of perioperative chemotherapy is four), followed by Tislelizumab monotherapy for one year.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China