NCT06056115Recruiting
Efficacy and Safety of Tislelizumab for Lung Adenocarcinoma With Asymptomatic Brain Metastatic
Efficacy and Safety of Tislelizumab Combined With Platinum-containing Drug Chemotherapy in First-line Treatment of Lung Adenocarcinoma With Asymptomatic Brain Metastatic
Source: ClinicalTrials.gov · Last updated 28 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 11 Apr 2023
- Start date
- 1 May 2023
- Primary completion date
- 12 Apr 2025
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06056115
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 May 2023 to the primary completion date, 12 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- 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;
Lab values
- Patients with EGFR mutation or ALK gene translocation;
Who the study is looking for
- 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;
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital) Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.