Tislelizumab Plus Chemotherapy as First-Line Treatment for Advanced Squamous NSCLC With Brain Metastases

Study Purpose

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.

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 or cytologically confirmed squamous non-small cell lung cancer; 2. Asymptomatic brain metastases or brain metastases that are relieved by dehydration therapy and remain clinically stable for at least 2 weeks. 3. 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. 4. Patients with stable brain metastasis symptoms after stereotactic radiotherapy are allowed (the number of stereotactic radiotherapy lesions is not more than 3) 5. No prior systemic treatment for metastatic NSCLC. 6. 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. 7. Aged ≥ 18 years and ≤ 75 years. 8. ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1. 9. Life expectancy of more than 3 months. 10. Have adequate organ function as indicated by the following laboratory values. 11. Written informed consent before any trial-related procedures are performed.

Exclusion Criteria:

Subjects with any of the following criteria may not be included in this study: 1. With mixed adenosquamous carcinoma or small cell lung cancer mainly composed of adenocarcinoma. 2. Currently participating in interventional clinical study treatment, or have received other investigational drugs or investigational device treatment before the first dose; 3. Received prior therapies targeting PD-1, PD-L1, CTLA-4, cytotoxic chemotherapy or other immune checkpoints inhibitors. 4. Received solid organ or blood system transplantation. 5. Have active autoimmune diseases requiring systemic therapy within 2 years before the first dose. 6. Diagnosis of immunodeficiency or systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of the study. 7. History of non-infectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year before the first dose. 8. Known history of human immunodeficiency virus (HIV) infection. 9. 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; 10. Subjects with active HCV infection. 11. Pregnant and lactating women. 12. Malignant tumors other than NSCLC within 5 years before screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell epithelial skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection

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.

NCT05207904
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 Recruiting
Countries China
Conditions

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

Non-Small Cell Squamous Lung Cancer, Brain Metastases
Arms & Interventions

Arms

Experimental: tislelizumab plus chemotherapy

Interventions

Drug: - Tislelizumab, paclitaxel, Carboplatin

Tislelizumab, 200mg administered intravenously (IV) on Day 1 of each 21-day cycle paclitaxel 175 mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle, 4-6cycle Carboplatin AUC 5 administered intravenously (IV) on Day 1 of each 21-day cycle, 4-6 cycle

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Status

Recruiting

Address

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000

Site Contact

Likun Chen, doctor

[email protected]

13798019964

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