Tislelizumab Combined With sCRT in Stage IIIB/C-IV Non-Squamous Non-Small Cell Lung Cancer：A Prospective, Single-Arm, Phase II Study
Recruiting · NCT07085182 · Interventional (participants receive a specific treatment) · Lead sponsor: Zibo Municipal Hospital
View the official record on ClinicalTrials.gov →Interventions studied
SBRT combined with Tislelizumab followed by Tislelizumab
What this trial is about
In clinical practice, some patients cannot tolerate concurrent chemoradiotherapy. The purpose of this study is to observe the efficacy and safety of Tislelizumab combined with platinum-based doublet chemotherapy followed by hypofractionated radiotherapy and Tislelizumab in patients with stage IIIB/C-IV non-squamous non-small cell lung cancer. This study aims to provide more treatment options for patients with locally advanced non-small cell lung cancer.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age 18-75 years old, gender is not limited;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Patients with stage IIIB/C-IV non-squamous non-small cell lung cancer confirmed by cytology or histology;
- Patients who have not received prior systemic therapy;
Exclusion criteria
- Patients with uncontrolled autoimmune diseases;
- Patients who have had autoimmune reactions in the past 6 months and have not improved or are unstable despite appropriate treatment, such as untreated or unstable pneumonia, thyroiditis, myocarditis, etc.;
- Patients known to carry driver gene mutations such as EGFR mutation, ALK translocation, BRAF, ROS1, RET, MET, etc.;
- Patients who have received prior systemic therapy, or those who have received adjuvant or neoadjuvant therapy with a recurrence time of less than 3 months from the last treatment;
- Patients with known allergies or contraindications to the study drug or its excipients;
- Pregnant or lactating female patients, or female patients of childbearing potential with a positive baseline pregnancy test;
- Female patients of childbearing potential or male patients with reproductive plans who are unwilling to use effective contraception during the entire trial period and for 6 months after the end of the trial;
- Patients whose comorbidities or other conditions may affect compliance with the protocol or are deemed unsuitable for participation in this study by the investigator.
Where it is running
1 location listed.
- Zibo Municipal Hospital - Zibo, Shandong, China