RecruitingPhase 2NCT07109401

Perioperative Immunotherapy for Resectable Limited-Stage SCLC

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


Sponsor

Fudan University

Enrollment

37 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing perioperative immunotherapy — adding an immune checkpoint drug (immunotherapy) before and after surgery — for patients with limited-stage small cell lung cancer (SCLC) that can be surgically removed. The hope is that immunotherapy combined with surgery may reduce the risk of the cancer coming back. **You may be eligible if:** - You are between 18 and 75 years old - You have been diagnosed with small cell lung cancer - Your cancer is limited-stage (stage IIB–IIIB) and has been assessed as surgically removable with the intent to cure (R0 resection) - Your cancer has been confirmed by biopsy (tissue or fluid) - You are able to provide written consent and follow the study schedule **You may NOT be eligible if:** - Your cancer has spread widely (extensive-stage SCLC) - Your tumor is not resectable (cannot be surgically removed) - You have significant health conditions that would make surgery or immunotherapy unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab (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

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NCT07109401


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