Actively Recruiting
Tislelizumab Consolidation Therapy After Radiotherapy or Sequential Chemoradiation in Locally Advanced NSCLC Patients
Led by Peking University Cancer Hospital & Institute · Updated on 2024-11-26
20
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The current standard of care for locally advanced non-small cell lung cancer (NSCLC) is concurrent chemoradiation and consolidation immunotherapy. In real world clinical practice, patients who cannot tolerate concurrent chemoradiation generally received radiotherapy alone or sequential chemoradiation. These patients are more likely to develop distant metastases and therefore may require tolerable systemic consolidation regimens. However, there is a lack of evidence from clinical studies on consolidation immunotherapy after radiotherapy alone or sequential chemoradiation. The aim of the study is to explore the efficacy and safety of Tislelizumab consolidation therapy after radiotherapy or sequential chemoradiation in locally advanced NSCLC patients who are intolerable of concurrent concurrent chemoradiation.
CONDITIONS
Official Title
Tislelizumab Consolidation Therapy After Radiotherapy or Sequential Chemoradiation in Locally Advanced NSCLC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with stage III (AJCC 8th) unresectable NSCLC, or resectable but intolerant or refusing surgery
- Intolerable of concurrent chemoradiation
- No progression after radiotherapy or sequential chemoradiation
- Chemotherapy: standard dose of 2-6 cycles of paclitaxel, pemetrexed or gemcitabine combined with platinum
- Radiotherapy: started within 3 months after chemotherapy using IMRT or VMAT, targeting primary tumor and regional lymph nodes, with 95% PTV dose 50Gy to 66Gy
- ECOG performance status 0-2
- PD-L1 expression 1% or higher
- Age 18 years or older with life expectancy over 3 months
- Adequate blood, biochemistry, and organ function confirmed within 7 days before first dose
- Ability to provide written informed consent and comply with study requirements
You will not qualify if you...
- Presence of EGFR-sensitive mutations or ALK rearrangements
- Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies
- Allergy to components of Tislelizumab
- Active malignancy within 2 years prior to enrollment except certain treated cancers
- History of interstitial lung disease or pneumonia requiring steroids
- Disease progression after radiotherapy or sequential chemoradiation
- Unresolved grade 2 or higher toxicities from prior treatments (except non-impactful ones like alopecia)
- Grade 2 or severe pneumonia from radiotherapy or sequential chemoradiation
- Live vaccine administration within 30 days before treatment start (except seasonal influenza vaccine without live virus)
- Severe infections needing systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to treatment
- Immunodeficiency or history of organ transplantation
- Active autoimmune disease requiring systemic therapy
- Long-term systemic immunosuppressive medication use
- Uncontrolled cardiovascular disease or significant QT interval abnormalities
- Abnormal liver or kidney function beyond specified limits
- Serious concomitant diseases such as severe hypertension, diabetes, thyroid disease, or active infection
- Diagnosed neurological or psychiatric disorders including epilepsy or dementia
- Considered unsuitable for the study by investigators
- Participation in other clinical studies
- Mixed lung cancer with small cell components
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital and Institute
Beijing, China, 100142
Actively Recruiting
Research Team
R
Rong Yu, MD
CONTACT
W
Wei Deng, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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