Trial intelligence / Profile preview

Tislelizumab Plus Chemotherapy and Concurrent Thoracic Radiotherapy as First-line Therapy for ES-SCLC

NCT06536868Phase 2

Key facts

Status
Recruiting
Start
Aug 2024
Primary completion
Dec 2026
Countries
1
Sponsor
The Second Hospital of Shanxi Medical University
Modality
Monoclonal Antibodies
Conditions
small cell lung cancer (SCLC)
01

Overview

Phase 2, open-label, single-arm trial of tislelizumab in small cell lung cancer (SCLC), sponsored by The Second Hospital of Shanxi Medical University. Primary endpoint: Progression-free Survival at 2 years. Started Aug 2024; status: recruiting.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • ICI+EC/EP+TRT

    Tislelizumab + Etoposide + Carboplatin/Cisplatin + Thoracic radiotherapy

03

Who it enrols

Patients aged 18-80 with confirmed extensive-stage small-cell lung cancer, ECOG 0-1, life expectancy >=3 months, no prior systemic therapy for extensive stage, and no prior PD-(L)1 therapy.

04

Endpoints

Primary

  • Progression-free Survival

Secondary

  • Objective Response Rate

  • Disease Control Rate

  • Overall Survival

  • Adverse events

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