NCT06056115 Efficacy and Safety of Tislelizumab for Lung Adenocarcinoma With Asymptomatic Brain Metastatic
| NCT ID | NCT06056115 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hebei Medical University Fourth Hospital |
| Condition | Lung Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2025-04-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2023-05-01 with a primary completion date of 2025-04-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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;
Contact & Investigator
Jian Shi, Dr.
PRINCIPAL INVESTIGATOR
The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)
Frequently Asked Questions
Who can join the NCT06056115 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Lung Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06056115 currently recruiting?
Yes, NCT06056115 is actively recruiting participants. Contact the research team at Shijian6668@126.com for enrollment information.
Where is the NCT06056115 trial being conducted?
This trial is being conducted at Shijiazhuang, China.
Who is sponsoring the NCT06056115 clinical trial?
NCT06056115 is sponsored by Hebei Medical University Fourth Hospital. The principal investigator is Jian Shi, Dr. at The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital). The trial plans to enroll 20 participants.