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Recruiting NCT06056115

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

No phase Interventional Lung Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tislelizumab,Platinum.
Who it may be relevant to
Registry conditions: Lung Adenocarcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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 .

Primary outcome measures

  • 1 years PFS [Time frame: up to 1year]
Secondary outcome measures (1)
  • The objective response rate (ORR) [Time frame: Through study completion, an average of 12 months]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital) — Shijiazhuang

Identifiers

NCT: NCT06056115 · 20220511

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗