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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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
Cancer Center of Sun-Yat Sen University (CCSYSU)
Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, China
Progression-Free Survival (PFS) rate at 12 months according to RECIST v1.1
Progression-free survival is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first
Time frame: 12months
Objective Response Rate (ORR) according to RECIST v1.1
ORR is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR).
Time frame: 36 months
Progression-free survival (PFS) according to RECIST v1.1
Progression-free survival is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first.
Time frame: 12 months
Overall Survival (OS)
OS is defined as the time from the starting date of study drug to the date of death due to any cause
Time frame: 36 months
Progression-free survival (PFS) according to RANO-BM
PFS2 is defined as the time from first intracranial disease progression to second/subsequent disease progression (intracranial or extracranial) after initiation of new anti-cancer therapy, or death from any cause, whichever occurs first
Time frame: 36 months
Duration of Response (DoR) according to RECIST v1.1
DoR is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first
Time frame: 36 months
Incidence and severity of treatment-emergent AEs (TEAEs)
TEAEs graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Time frame: 36 months
Neurocognitive impairment
Neurocognitive impairment according to Hopkins Verbal Learning Test-Revised(HVLT-R)
Time frame: 36 months
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