Actively Recruiting
Stereotactic Body Radiotherapy Followed by Tislelizumab Plus Platinum-based Chemotherapy Versus Tislelizumab Plus Platinum-based Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Stage Ⅱ-Ⅲ Non-small Cell Lung Cancer: A Phase Ⅲ, Randomized, Multicenter, Prospective Study
Led by Yang Hong · Updated on 2025-05-29
360
Participants Needed
1
Research Sites
276 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare the efficacy and safety of neoadjuvant Stereotactic Body Radiotherapy (SBRT) combined with immunochemotherapy versus neoadjuvant immunochemotherapy. The main questions it aims to answer are: Dose SBRT combined with immunochemotherapy improve event-free survival? Is SBRT combined with immunochemotherapy safe enough? Participants will: Receive neoadjuvant SBRT combined with immunochemotherapy or neoadjuvant immunochemotherapy. Tumor assessment will be performed prior to surgery. Surgery will be performed within 4 to 6 weeks (+ 7 days) after completion of the last cycle of immunochemotherapy.
CONDITIONS
Official Title
Stereotactic Body Radiotherapy Followed by Tislelizumab Plus Platinum-based Chemotherapy Versus Tislelizumab Plus Platinum-based Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Stage Ⅱ-Ⅲ Non-small Cell Lung Cancer: A Phase Ⅲ, Randomized, Multicenter, Prospective Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily agree to participate and sign informed consent
- Diagnosed with untreated stage IIa to IIIa non-small cell lung cancer or potentially resectable stage IIIb NSCLC confirmed by biopsy
- Underwent baseline PET/CT or chest plus upper abdominal CT and brain MRI for clinical staging
- Lung tumors assessed as resectable or potentially resectable by a multidisciplinary team including thoracic surgeon
- Eastern Cooperative Oncology Group Performance Status of 0 to 1
- Hematology requirements: neutrophils ≥ 1500 x 10^9/L; platelets ≥ 100 x 10^9/L; hemoglobin > 9.0 g/dL; serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 40 mL/min; AST/ALT ≤ 3 x ULN; total bilirubin ≤ 1.5 x ULN; FEV1 ≥ 1.2 L or > 40% predicted; INR/APTT within normal range
- Age between 18 and 75 years
You will not qualify if you...
- Autoimmune diseases (except vitiligo, type 1 diabetes, or hypothyroidism managed with hormone replacement therapy without recurrence)
- Systemic corticosteroid treatment > 10 mg daily prednisolone or equivalent within 14 days before enrollment (inhaled or topical corticosteroids allowed if no autoimmune disease)
- Prior chest radiotherapy
- Active bleeding before treatment
- Severe heart, lung, liver, or kidney insufficiency
- Diabetes for more than 10 years or poorly controlled blood glucose
- Interstitial lung disease or non-infectious pneumonia
- EGFR mutations or ALK fusion positive NSCLC
- Other prior malignancies except certain skin cancers or carcinoma in situ unless in complete response for ≥ 2 years without ongoing treatment
- Medically, psychologically, or physiologically unable to complete the study or understand study information
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA, or other immune checkpoint inhibitors
- Active hepatitis B or C infection
- Positive HIV test or AIDS diagnosis
- Hypersensitivity to study drugs
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
H
Hong Yang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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