Using Tislelizumab and chemotherapy for lung cancer with brain metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the efficacy and safety of Tislelizumab, an immune checkpoint inhibitor, in combination with platinum-based chemotherapy for patients with lung adenocarcinoma that has spread to the brain but remains asymptomatic. The trial focuses on patients who have not previously received systemic treatment and have measurable lesions outside the skull. Additionally, the study aims to explore related biomarkers to better understand treatment efficacy and potential resistance mechanisms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with metastatic (stage IV) lung adenocarcinoma who have not been systematically treated and are histologically or cytologically confirmed as unable to undergo radical surgery or radiotherapy based on AJCC Stage VIII;
2. Patients with brain metastases confirmed by imaging;
3. Patients with asymptomatic BMS after initial diagnosis, local BMS surgery or radiotherapy;
4. ECOG PS: 0-1;
5. Measurable target lesions outside the skull (as per RECIST 1.1);
6. Life expectancy greater than 3 months;

Exclusion Criteria:

1. Patients had been treated with immune checkpoint inhibitors such as anti-PD-1, PD-L1, or CTLA-4 therapy;
2. The patient had received systemic chemotherapy as advanced treatment;
3. Patients with EGFR mutation or ALK gene translocation;
4. The patient had received approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin 2, and tumor necrosis factor) within 4 weeks prior to initial administration;
5. Clinically uncontrolled pleural fluid or ascites requiring puncture drainage within 2 weeks prior to initial administration;

Where it's running

• The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)
  Shijiazhuang, Hebei, China Recruiting

Study contacts

• Principal investigator: Jian Shi, Dr. — The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)
• Study coordinator: Jian Shi, Dr.
• Email: Shijian6668@126.com
• Phone: +86-311-86095794

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.