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

Lung Adenocarcinoma Clinical Trial

Official title:

Efficacy and Safety of Tislelizumab Combined With Platinum-containing Drug Chemotherapy in First-line Treatment of Lung Adenocarcinoma With Asymptomatic Brain Metastatic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06056115
• Other study ID #: 20220511
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 12, 2026

Study information

• Verified date: September 2023
• Source: Hebei Medical University Fourth Hospital
• Contact: Jian Shi, Dr.
• Phone: +86-311-86095794
• Email: Shijian6668[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 12, 2026
• Est. primary completion date: April 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Lung Adenocarcinoma

Intervention

Drug:
• Tislelizumab,Platinum
Induction therapy stage: Tislelizumab plus platinum-containing drug chemotherapy was administered every 3 weeks and was expected to complete 6 cycles of treatment. 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 .

Locations

Country	Name	City	State
China	The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Fourth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 years PFS	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	up to 1year
Secondary	The objective response rate (ORR)	Assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	Through study completion, an average of 12 months