Chemotherapy, Hypofractionated Radiotherapy, NSCLC, Tislelizumab
Conditions
Brief summary
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.
Interventions
SBRT:3-10Gy/F, once daily, 5 times a week; Tislelizumab(200mg,iv,q3w):Tislelizumab was added after five sessions of SBRT radiotherapy.
Sponsors
Zibo Municipal Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-75 years old, gender is not limited; 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 3. Patients with stage IIIB/C-IV non-squamous non-small cell lung cancer confirmed by cytology or histology; 4. Patients who have not received prior systemic therapy;
Exclusion criteria
1. Patients with uncontrolled autoimmune diseases; 2. 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.; 3. Patients known to carry driver gene mutations such as EGFR mutation, ALK translocation, BRAF, ROS1, RET, MET, etc.; 4. 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; 5. Patients with known allergies or contraindications to the study drug or its excipients; 6. Pregnant or lactating female patients, or female patients of childbearing potential with a positive baseline pregnancy test; 7. 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; 8. Patients whose comorbidities or other conditions may affect compliance with the protocol or are deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Up to approximately 30 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to approximately 30 months | 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) | Up to ~60 months | OS is defined as the time from first dose until the date of death due to any cause |
| Disease Control Rate (DCR) | Up to ~24 months | 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. |
| Adverse events | Through study completion, an average of 2 year | The incidence and severity of AEs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0). |
Countries
China
Contacts
Primary ContactQiang Wang
Outcome results
None listed