Efficacy and Safety of Tislelizumab for Lung Adenocarcinoma With Asymptomatic Brain Metastatic
Recruiting · NCT06056115 · Interventional (participants receive a specific treatment) · Lead sponsor: Hebei Medical University Fourth Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Tislelizumab,Platinum
What this trial is about
Brain metastasis of lung cancer is one of the most important metastasis pathways in patients with life-threatening diseases. This study explore the efficacy and safety of Tislelizumab combining with platinum-containing drug chemotherapy in the first-line treatment of Lung Adenocarcinoma With Asymptomatic Brain Metastatic. Meanwhile, Related biomarkers were explored to provide theoretical basis for efficacy evaluation and resistance mechanism.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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;
- Patients with brain metastases confirmed by imaging;
- Patients with asymptomatic BMS after initial diagnosis, local BMS surgery or radiotherapy;
- ECOG PS: 0-1;
- Measurable target lesions outside the skull (as per RECIST 1.1);
- Life expectancy greater than 3 months;
Exclusion criteria
- Patients had been treated with immune checkpoint inhibitors such as anti-PD-1, PD-L1, or CTLA-4 therapy;
- The patient had received systemic chemotherapy as advanced treatment;
- Patients with EGFR mutation or ALK gene translocation;
- 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;
- Clinically uncontrolled pleural fluid or ascites requiring puncture drainage within 2 weeks prior to initial administration;
Where it is running
1 location listed.
- The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital) - Shijiazhuang, Hebei, China