Prospective Phase II Clinical Study of Sintilimab Combined With Bevacizumab for Driving Gene-negative, Asymptomatic Brain Metastases From Non-small Cell Lung Cancer

Sun Yat-sen University1 site in 1 country60 target enrollmentApril 29, 2019

ConditionsBrain Metastases Non Small Cell Lung Cancer Sintilimab Bevacizumab

Interventionssintilimab

Drugssintilimab

Overview

Phase: Phase 2
Intervention: sintilimab
Conditions: Brain Metastases
Sponsor: Sun Yat-sen University
Enrollment: 60
Locations: 1
Primary Endpoint: iORR
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective phase II clinical study to assess the efficacy of Sintilimab combined with Bevacizumab for driving gene-negative, asymptomatic brain metastases from non-small cell lung cancer by intracranial ORR(iORR),also iPFS,ORR and PFS.The safety and tolerability is evaluated as well.

Registry

clinicaltrials.gov

Start Date

April 29, 2019

End Date

December 2022

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Li-kun Chen

medical doctor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Patients with NSCLC confirmed by histology or cytology;
•Patients with asymptomatic brain metastasis or brain metastasis whose symptoms of intracranial hypertension have been alleviated after dehydration treatment should keep the clinical stable state for at least 2 weeks.For patients requiring hormone dehydration therapy, hormone therapy should be discontinued 3 days before the first dose of the study drug.
•Appraisable disease, the diameter of at least one measurable lesion in the brain must be 5mm;
•The detection results of tumor tissue biomarkers should meet the following conditions simultaneously: EGFR has no sensitive mutation;ALK rearrangement negative;for never treated patients, they also needed to meet PD-L1 \>50% or TMB\>12Mut/Mb (second-generation sequencing).
•Adult patients (≥ 18 years and ≤75 years). ECOG Performance Status 0 or 1 Life expectancy of at least 12 weeks.,Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L. Total bilirubin £ 1.5 x upper limit of normal (ULN). ALT and AST \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases. Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula).
•Ability to follow study and follow-up procedures;
•Prior to the implementation of any trial-related procedures, a written informed consent shall be signed.

Exclusion Criteria

•Mixed non-small cell and small cell carcinoma;
•Brain metastasis with hemorrhage;
•Currently participating in interventional clinical research and treatment, or receiving other research drugs or using research instruments within 4 weeks before the first dose;
•Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting another stimulation or synergistic inhibition of T cell receptors (e.g., CTLA-4, CD137);
•Received solid organ or blood system transplantation;
•Received \>30GY pulmonary radiotherapy 6 months before the first dose;
•Active autoimmune diseases requiring systemic treatment (such as the use of disease-relieving drugs, corticosteroids or immunosuppressants) occurred within 2 years before the first dose.Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic;
•Received systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of the study or diagnosed as immunodeficiency;a physiological dose of glucocorticoid (10 mg/ day of prednisone or equivalent) is permitted;
•History of non-infectious pneumonia requiring glucocorticoid therapy or current interstitial pulmonary disease was found within 1 year before the first dose;
•History of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive)