NCT04507217

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• NSCLC Stage IV
• Brain Metastases
• PD-1 Antibody

Interventions

Type	Name	Description
DRUG	Tislelizumab, Carboplatin, Pemetrexed	Tislelizumab: 200mg administered intravenously (IV) on Day 1 of each 21-day cycle Carboplatin: AUC 5 administered intravenously (IV) on Day 1 of each 21-day cycle, 4 cycles Pemetrexed: 500mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle

Timeline

• Start date: 2020-09-15
• Primary completion: 2022-11-15
• Completion: 2023-01-30
• First posted: 2020-08-11
• Last updated: 2023-05-25

Locations

2 sites across 1 country: China