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Clinical Trials in China / NCT06056115
Recruiting Not applicable

Efficacy and Safety of Tislelizumab for Lung Adenocarcinoma With Asymptomatic Brain Metastatic

NCT06056115 · tracked via the Priya Life Science China tracker
Sponsor
Hebei Medical University Fourth Hospital
Phase
Not applicable
Started
2023-05-01
Last updated
2023-09-28

Condition(s) studied

Lung Adenocarcinoma

Investigational drug(s) / intervention(s)

Tislelizumab,Platinum

Tislelizumab,Platinum: 1. Induction therapy stage: Tislelizumab plus platinum-containing drug chemotherapy was administered every 3 weeks and was expected to complete 6 cycles of treatment. 2. Maintenance treatment phase: After completion of the induction therapy phase, patients whose antitumor response was confirmed as complete response, partial response, and disease stable according to RECIST v1.1 criteria were admitted to maintenance therapy .

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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;

Primary outcome measure(s)

  • 1 years PFS — up to 1year
    the time from the date of first dose of study treatment to the date of first documentation of disease progression using RECIST v1.1 or death, whichever occurs first

Trial sites (1)

FacilityCityRegionStatus
The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital) Shijiazhuang Hebei Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06056115 on ClinicalTrials.gov ↗ ← All trials in China