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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Histologically confirmed metastatic (Stage IV) not amenable to curative surgery or radiotherapy, non-squamous NSCLC according to American Joint Committee on Cancer, 8th Edition. 2. Imaging confirmed brain metastases. 3. No prior systemic treatment for metastatic NSCLC. 4. Subjects with asymptomatic untreated brain metastases: no neurological symptoms, no requirements for corticosteroids, no surrounding edema, and no lesion >1.5 cm) 5. Subjects with previously treated brain metastases: clinically stable for at least 2 weeks, have no evidence of new or enlarging brain metastases, and be off steroids 3 days prior to trial initiation as per local site assessment. 6. ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1. 7. Have at least one measurable extracranial target lesion (per RECIST 1.1) 8. Life expectancy ≥ 3 months. 9. Have adequate organ function as indicated by the following laboratory values.

Exclusion Criteria:

1. Received prior therapies targeting PD-1, PD-L1, CTLA-4 or other immune checkpoints inhibitors. 2. Received prior systemic cytotoxic chemotherapy for advanced disease. 3. Have activating EGFR mutations or ALK gene rearrangements. 4. Have brain metastases that is suitable for surgical resection. 5. Treatment with any approved systemic anti-cancer therapy or systemic immune-stimulatory agents (including but not limited to interferons, interleukin IL-2, and tumor necrosis factor) within 28 days prior to initiation of study treatment. 6. Clinically uncontrolled pleural effusion or ascites that requires pleurocentesis or abdominal tapping for drainage within 2 weeks prior to initiation of study treatment. 7. Have Active leptomeningeal metastasis. 8. History of allergic reactions to any study drugs. 9. CrCl < 45 mL/min. 10. Patients with active viral hepatitis that requires treatment. 11. Active autoimmune diseases that requires treatment and may affect study treatment estimated by investigator. 12. Any condition that required systemic treatment with either corticosteroids or any other immunosuppressive medication that may affect study treatment estimated by investigator. 13. Severe chronic or active infections requiring systemic antibacterial, anti-fungal or antiviral therapy. 14. With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc. 15. Underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse or dependence that would be unfavorable for the administration of study drug or affect the explanation of drug toxicity or AEs (Adverse Events) or result in insufficient or might impair compliance with study conduct. 16. Concurrent participation in another clinical study. 17. Pregnant, breastfeed, or expect to conceive or father children within the projected duration of the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04507217
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sun Yat-sen University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

NSCLC Stage IV, Brain Metastases, PD-1 Antibody
Arms & Interventions

Arms

Experimental: BM without prior radiotherapy

No Prior Systemic treatment for Stage IV NSQ-NSCLC With asymptomatic untreated BM

Experimental: BM with prior radiotherapy

No Prior Systemic treatment for Stage IV NSQ-NSCLC With Clinical stable BM with prior radiotherapy

Interventions

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Li Zhang, Master

zhangli@sysucc.org.cn

+86-13902282893

For additional contact information, you can also visit the trial on clinicaltrials.gov.