About this trial
In clinical practice, some patients cannot tolerate concurrent chemoradiotherapy. The purpose of this study is to observe the efficacy and safety of 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Tumor histology or hematology confirms no EGFR mutations and no mutations or positive driver genes for ALK, BRAF, ROS1, RET, MET, etc or Targeted drug therapy leads to drug resistance progression
Disqualifiers
Patients with uncontrolled autoimmune diseases;
Patients who have experienced autoimmune reactions within the past 6 months and whose conditions have not improved or are unstable after corresponding treatments, such as pneumonia, thyroiditis, myocarditis, etc. that have not stabilized after treatment;
Patients who have previously received systemic chemotherapy, or adjuvant or neoadjuvant therapy, and the time from the last treatment to recurrence is less than 3 months;
Patients with known allergies or contraindications to the study drug or its excipients;
Trial design
Single group
Treatments tested in this trial
SBRT combined with Tislelizumab followed by Tislelizumab
DrugThe enrolled population consists of patients with stage IIIB/C-IV non-small cell lung cancer who are driver gene negative or unknown, as well as those with driver gene positive targeted drug resistance. The patients reaching SD, PR, or CR after 4 cycles of platinum based dual drug chemotherapy. The patient will receive SBRT radiotherapy combined with Tislelizumab treatment, followed by Tislelizumab maintenance therapy.
Treatment groups
Trial outcomes
Primary outcomes
One-year PFS rate
The proportion of patients who survived for more than one year after treatment without disease progression
Secondary outcomes
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose until the first documentation of progression or death from any cause, whichever occurs first, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR), as assessed by the investigator using RECIST v1.1.
Overall survival (OS)
OS is defined as the time from first dose until the date of death due to any cause
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD), as assessed by the investigator using RECIST v1.1.
Sponsors and contacts
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