Actively Recruiting
Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC
Led by Shandong Cancer Hospital and Institute · Updated on 2024-02-14
30
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy in resectable stage IIIA and IIIB (T3-4N2) non-small cell lung cancer (NSCLC) patients. Inclusion criteria are: age 18-75, pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC, absence of EGFR, ALK, and ROS1 gene mutations, and Eastern Cooperative Oncology Group (ECOG) status 0-1. All patients receive three cycles of camrelizumab combined with platinum-based doublet chemotherapy, followed by curative surgery within 4-6 weeks after completion of chemotherapy. Patients undergo 18F-fluorodeoxyglucose (FDG) PET/CT scans in 1 week before treatment and 1 week before surgery, and peripheral blood samples are collected for biomarker analysis. The primary endpoints for follow-up are pathologic complete response (pCR) rate and major pathological response (MPR) rate, while secondary endpoints include safety and progression-free survival. Exploratory endpoints include molecular imaging research and biomarker analysis.
CONDITIONS
Official Title
Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) non-small cell lung cancer
- No mutations in EGFR, ALK, or ROS1 genes
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Signed written informed consent before any trial-related procedures
- Adequate organ function with no contraindications to chemotherapy, including: absolute neutrophil count 60 1,500 4 10^9/L, platelets 60 100 4 10^9/L, hemoglobin 60 90 mg/L, creatinine 4 1.5 times upper limit of normal or creatinine clearance 60 40 mL/min, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 3 2.5 times upper limit of normal, alkaline phosphatase (ALP) 3 5 times upper limit of normal, bilirubin 3 1.5 times upper limit of normal
You will not qualify if you...
- Diagnosis of any other malignant tumor
- Prior treatment with chemotherapy or immune checkpoint inhibitors
- Insufficient caloric or fluid intake despite dietitian consultation or tube feeding
- Active infection requiring systemic therapy not resolved 3 to 7 days before treatment
- Inability to tolerate chemoradiotherapy or surgery due to severe heart or lung dysfunction
- History of interstitial lung disease or non-infectious pneumonia
- Active autoimmune disease requiring systemic therapy in past 2 years
- Known HIV infection or viral hepatitis
- Previous allogeneic stem cell or solid organ transplant
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 250117
Actively Recruiting
Research Team
X
Xue Meng, MD, PhD
CONTACT
G
Guoxin Cai, 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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