Actively Recruiting
A Study Evaluating Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade in Patients With Locally Advanced Non-Small Cell Lung Cancer
Led by Sun Yat-sen University · Updated on 2026-01-14
56
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will enroll patients with locally advanced non-small cell lung cancer (NSCLC). Patients will receive neoadjuvant chemotherapy combined with dual immune checkpoint blockade (PD-1/CTLA-4), bevacizumab and thymosin alpha 1, followed by concurrent chemoradiotherapy, and finally consolidation therapy with dual immune checkpoint blockade (PD-1/CTLA-4), surufatinib and thymosin alpha 1. The study aims to evaluate the efficacy and safety of this treatment regimen.
CONDITIONS
Official Title
A Study Evaluating Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade in Patients With Locally Advanced Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Histologically or cytologically confirmed locally advanced, unresectable (Stage III) non-small cell lung cancer
- EGFR, ALK, and ROS1 wild-type
- No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy
- Expected survival of at least 12 weeks
- WHO Performance Status score of 0 or 1
- Female subjects must not be breastfeeding
- Women of childbearing potential must use contraception during treatment and for 5 months after last dose
- Adequate organ and bone marrow function including FEV1 ≥ 800 mL, absolute neutrophil count ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 9.0 g/dL, creatinine clearance ≥ 50 mL/min, serum bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤ 2.5 x upper limit of normal
You will not qualify if you...
- Concurrent enrollment in another clinical study, except observational non-interventional studies
- Mixed small cell and non-small cell lung cancer histology
- Prior use of anti-PD-1, anti-PD-L1, or anti-CTLA4 antibodies
- Major surgery within 4 weeks prior to study entry (except vascular access placement)
- Active or prior autoimmune disease within past 2 years
- Active or prior documented inflammatory bowel disease
- History of primary immunodeficiency or organ transplant requiring immunosuppression
- Uncontrolled illness or infection, symptomatic heart failure, unstable angina, arrhythmia, active peptic ulcer disease, active bleeding disorders, hepatitis B, hepatitis C, HIV, or psychiatric illness limiting compliance
- Known history of tuberculosis
- Another primary malignancy within 5 years except certain treated skin or cervical cancers
- Pregnancy, breastfeeding, or not using effective birth control if of reproductive potential
- Development of distant metastasis or locoregional progression exceeding radiation limits during chemoradiation
- WHO Performance Status of 2 to 4 during chemoradiation
- Inadequate organ or marrow function during chemoradiation
- Progression during platinum-based concurrent chemoradiation
- Use of immunosuppressive medication within 28 days before consolidation therapy except certain corticosteroids
- Unresolved toxicity greater than Grade 2 from prior chemoradiation
- Grade 2 or higher pneumonitis from prior chemoradiation
- Prior Grade 3 or higher immune-related adverse events or unresolved immune-related adverse events higher than Grade 1
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
D
DaQuan Wang, 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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