drugset / Trial / NCT04507217

Tislelizumab Combined With Pemetrexed/ Carboplatin in Patients With Brain Metastases of Non-squamous NSCLC

NCT04507217 ↗

Phase 2 Completed 36 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

Summary

This is a phase II, Open-Label, Multicenter, Prospective Clinical Study to Investigate the Efficacy and Safety of Tislelizumab Combined with Pemetrexed/ Carboplatin in Patients with Brain Metastases of Non-squamous Non-small Cell Lung Cancer. The primary end point is PFS, and secondary endpoint is ORR, OS, DoR and Neurocognitive impairment. during the study, the exploratory objectives including (1) PD-L1 expression, TMB, and other potential predictive biomarkers, correlated with response to treatment (2) Progression-free survival based on intracranial response (iPFS) according to RECIST 1.1 and RANO-BM

Timeline

Start
2020-09-15
Primary completion
2022-11-15
Completion
2023-01-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous