Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06056115

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shijiazhuang, Hebei, China

Location status: Recruiting

Location contact

Jian Shi, Dr.

CONTACT

[email protected]

+86-311-86095794

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Treatment and study plan

Tislelizumab,Platinum

Drug
  • 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 .

Primary outcomes

  1. 1 years PFS

    Time frame: 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 outcomes

  1. The objective response rate (ORR)

    Time frame: Through study completion, an average of 12 months

    Assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Shi, Dr.

CONTACT

[email protected]

+86-311-86095794

Sponsors and collaborators

Lead sponsor

Hebei Medical University Fourth Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 28, 2023
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.