A Phase II, Prospective Clinical Study to Evaluate the Efficacy and Safety of Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With Brain Metastases of Squamous Non-small Cell Lung Cancer

Sun Yat-sen University1 site in 1 country41 target enrollmentJune 17, 2021

ConditionsNon-Small Cell Squamous Lung Cancer Brain Metastases

InterventionsTislelizumab, paclitaxel, Carboplatin

DrugsTislelizumab, paclitaxel, Carboplatin

Overview

Phase: Phase 2
Intervention: Tislelizumab, paclitaxel, Carboplatin
Conditions: Non-Small Cell Squamous Lung Cancer
Sponsor: Sun Yat-sen University
Enrollment: 41
Locations: 1
Primary Endpoint: intracranial progression-free survival (iPFS) after treatment with tislelizumab plus chemotherapy in patients with asymptomatic brain metastases or stable symptoms after stereotactic radiotherapy (according to RECIST 1.1)
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a prospective, single-arm, phase II clinical study to evaluate the efficacy and safety of Tislelizumab Plus Chemotherapy in patients with squamous NSCLC with brain metastases who had not previously received systemic therapy.

Registry

clinicaltrials.gov

Start Date

June 17, 2021

End Date

June 30, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Li-kun Chen

sun yat-sen university cancer center

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed squamous non-small cell lung cancer;
•Asymptomatic brain metastases or brain metastases that are relieved by dehydration therapy and remain clinically stable for at least 2 weeks
•MRI confirmed tumor parenchymal metastases, ≥ 3 brain lesions; or patients with 1-2 brain lesions but do not require local treatment or refuse local treatment. At least one measurable lesion in the brain lesion must be ≥ 5mm in diameter; patients with local meningeal metastasis are allowed, but those with extensive meningeal metastasis are not included
•Patients with stable brain metastasis symptoms after stereotactic radiotherapy are allowed (the number of stereotactic radiotherapy lesions is not more than 3)
•No prior systemic treatment for metastatic NSCLC
•Tumor tissue biomarker detection results must meet the following conditions at the same time: （1）EGFR mutation negative.（2）ALK rearrangement negative.（3）There are sufficient tissue samples for PD-L1 detection
•Aged ≥ 18 years and ≤ 75 years
•ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1
•Life expectancy of more than 3 months
•Have adequate organ function as indicated by the following laboratory values

Exclusion Criteria

•Subjects with any of the following criteria may not be included in this study:
•With mixed adenosquamous carcinoma or small cell lung cancer mainly composed of adenocarcinoma
•Currently participating in interventional clinical study treatment, or have received other investigational drugs or investigational device treatment before the first dose;
•Received prior therapies targeting PD-1, PD-L1, CTLA-4, cytotoxic chemotherapy or other immune checkpoints inhibitors
•Received solid organ or blood system transplantation
•Have active autoimmune diseases requiring systemic therapy within 2 years before the first dose
•Diagnosis of immunodeficiency or systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of the study
•History of non-infectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year before the first dose
•Known history of human immunodeficiency virus (HIV) infection
•Untreated active hepatitis B; Note: hepatitis B subjects who meet the following criteria are also eligible: a) HBV viral load must be \< 1000 copies/ml before the first dose, and subjects should receive anti-HBV therapy to avoid viral reactivation throughout the study chemotherapy drug treatment b) For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but viral reactivation needs to be closely monitored;

Arms & Interventions

tislelizumab plus chemotherapy

Intervention: Tislelizumab, paclitaxel, Carboplatin

Outcomes

Primary Outcomes

intracranial progression-free survival (iPFS) after treatment with tislelizumab plus chemotherapy in patients with asymptomatic brain metastases or stable symptoms after stereotactic radiotherapy (according to RECIST 1.1)

Time Frame: 12months

Intracranial Progression-free survival is defined as the time from the starting date of study drug to the date of first documentation of intracranial disease progression or death, whichever occurs first