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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    41
  • sponsor
    Sun Yat-sen University
Updated on 21 March 2022

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.

Details
Condition Non-Small Cell Squamous Lung Cancer, Brain Metastases
Treatment Tislelizumab, paclitaxel, Carboplatin
Clinical Study IdentifierNCT05207904
SponsorSun Yat-sen University
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

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
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
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
Subjects with active HCV infection
Pregnant and lactating women
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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