Using Tislelizumab and chemotherapy for lung cancer with brain metastases

Efficacy and Safety of Tislelizumab Combined With Platinum-containing Drug Chemotherapy in First-line Treatment of Lung Adenocarcinoma With Asymptomatic Brain Metastatic

This study is testing if a new immune therapy combined with chemotherapy can help people with lung cancer that has spread to the brain but isn’t causing symptoms yet.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hebei Medical University Fourth Hospital (Academic / other)
• Drugs / interventions: chemotherapy, Tislelizumab
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT06056115 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with stage IV lung adenocarcinoma who have brain metastases but are asymptomatic and have not received prior systemic treatment.

Not a fit: Patients who have previously been treated with immune checkpoint inhibitors or systemic chemotherapy are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with lung adenocarcinoma and asymptomatic brain metastases.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches in treating lung cancer, indicating potential for success in this trial.

Eligibility criteria

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 this trial is running

Shijiazhuang, Hebei

• 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.

Conditions Lung Adenocarcinoma