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

Not Applicable

Recruiting

• Conditions: Lung Adenocarcinoma
• Interventions: Drug: Tislelizumab,Platinum

• Registration Number: NCT06056115
• Lead Sponsor: Hebei Medical University Fourth Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-11
• Study Start: 2023-05-01
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-24
• Last Update Submitted: 2023-09-24
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28
• Primary Completion: 2025-04-12
• Study Completion: 2026-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tislelizumab Combined With Platinum-containing Drug Chemotherapy	Tislelizumab,Platinum	1. Tislelizumab PD-1 inhibitor 2. Platinum-containing drug chemotherapy

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
The objective response rate (ORR)	Through study completion, an average of 12 months	Assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Trial Locations

Locations (1)

The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital); 🇨🇳 Shijiazhuang, Hebei, China