Actively Recruiting
Neoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC（neoSCORE Ⅱ）
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2022-12-14
250
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 3, prospective, randomized, open-label, multi-center study that assesses the efficacy and safety of neoadjuvant therapy with different cycles of sintilimab combined with chemotherapy for Resectable Squamous Cell NSCLC. This trial will also explore the biomarkers of neoadjuvant immunochemotherapy.
CONDITIONS
Official Title
Neoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC（neoSCORE Ⅱ）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form and willing to follow study procedures
- Aged 18 to 75 years, male or female
- Confirmed diagnosis of squamous cell non-small cell lung cancer by cytology or histology
- At least one measurable tumor focus based on RECIST 1.1 criteria
- Resectable stage cIA-cIIB squamous NSCLC according to the 8th AJCC TNM staging, with no prior treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than 6 months
- Adequate organ function including specific blood counts, liver and kidney function, coagulation, and normal thyroid function
- Negative pregnancy test for women of reproductive age before first treatment
- Use of medically approved contraception during treatment and for specified periods afterward
You will not qualify if you...
- History of malignancies within 5 years prior to first dose, except certain skin cancers and carcinoma in situ
- Participation in other clinical trials or use of other investigational drugs within 4 weeks before first dose
- Previous treatment with immune checkpoint inhibitors targeting PD-1, PD-L1, PD-L2, or T cell receptor modulators
- Active autoimmune diseases requiring systemic treatment within 2 years before first dose
- Systemic glucocorticoid or immunosuppressive therapy within 7 days before first dose, except low-dose physiological steroids
- History of allogeneic organ or hematopoietic stem cell transplantation (except corneal transplantation)
- Allergy to sintilimab, carboplatin, albumin-bound paclitaxel, or their components
- Not fully recovered from prior treatment-related toxicities (except fatigue or hair loss)
- Known HIV infection
- Untreated active Hepatitis B or active Hepatitis C infection
- Receipt of live vaccines within 30 days before first dose
- Pregnant or breastfeeding women
- Serious or uncontrolled systemic diseases including significant heart conditions, pulmonary diseases, infections, liver diseases, uncontrolled diabetes, significant proteinuria, or mental disorders preventing cooperation
- Any medical condition or abnormal test result that may interfere with study participation or safety as judged by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
F
Fuming Qiu
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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