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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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;

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06056115
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hebei Medical University Fourth Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jian Shi, Dr.
Principal Investigator Affiliation	The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lung Adenocarcinoma

Arms & Interventions

Arms

Experimental: Tislelizumab Combined With Platinum-containing Drug Chemotherapy

1. Tislelizumab PD-1 inhibitor 2. Platinum-containing drug chemotherapy

Interventions

Drug: - 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 .

Contact a Trial Team

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International Sites

Shijiazhuang, Hebei, China

Status

Recruiting

Address

The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)

Shijiazhuang, Hebei,

Site Contact

Jian Shi, Dr.

[email protected]

+86-311-86095794

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