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

NCT06056115 | Recruiting

• 1 other identifier: 20220511
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The objective response rate (ORR)

  Through study completion, an average of 12 months

Study Arms (1)

Tislelizumab Combined With Platinum-containing Drug Chemotherapy

EXPERIMENTAL

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

Drug: Tislelizumab,Platinum

Interventions

Tislelizumab,Platinum DRUG

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 .

Tislelizumab Combined With Platinum-containing Drug Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Patients with brain metastases confirmed by imaging;
• Patients with asymptomatic BMS after initial diagnosis, local BMS surgery or radiotherapy;
• ECOG PS: 0-1;
• Measurable target lesions outside the skull (as per RECIST 1.1);
• Life expectancy greater than 3 months;

You may not qualify if:

• Patients had been treated with immune checkpoint inhibitors such as anti-PD-1, PD-L1, or CTLA-4 therapy;
• The patient had received systemic chemotherapy as advanced treatment;
• Patients with EGFR mutation or ALK gene translocation;
• 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;
• Clinically uncontrolled pleural fluid or ascites requiring puncture drainage within 2 weeks prior to initial administration;

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

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

Shijiazhuang, Hebei, China

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

tislelizumab; Platinum

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Jian Shi, Dr.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Shi, Dr.

CONTACT

+86-311-86095794; Shijian6668@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: September 28, 2023
• Study Start: May 1, 2023
• Primary Completion: April 12, 2025
• Study Completion (Estimated): December 12, 2026
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)