Tislelizumab Combined With sCRT in Stage IIIB/C-IV Non-Squamous Non-Small Cell Lung Cancer：A Prospective, Single-Arm, Phase II Study
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: SBRT combined with Tislelizumab followed by Tislelizumab.
- Who it may be relevant to
- Registry conditions: NSCLC, Tislelizumab, Chemotherapy, Hypofractionated Radiotherapy. 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 →
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Official title
Tislelizumab Combined With sCRT in Stage IIIB/C-IV Non-Squamous Non-Small Cell Lung Cancer
Overview
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
- Drug SBRT combined with Tislelizumab followed by Tislelizumab
SBRT:3-10Gy/F, once daily, 5 times a week; Tislelizumab(200mg,iv,q3w):Tislelizumab was added after five sessions of SBRT radiotherapy.
Primary outcome measures
- Progression-Free Survival (PFS) [Time frame: Up to approximately 30 months]
Secondary outcome measures (4)
- Objective Response Rate (ORR) [Time frame: Up to approximately 30 months]
- Overall Survival (OS) [Time frame: Up to ~60 months]
- Disease Control Rate (DCR) [Time frame: Up to ~24 months]
- Adverse events [Time frame: Through study completion, an average of 2 year]
Eligibility criteria
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.
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
- Zibo Municipal Hospital — Zibo
Identifiers
NCT: NCT07085182 · 2024-Ethical Review -01