Actively Recruiting
68Ga-grazytracer PET/CT for Early Evaluation of Neoadjuvant Immunotherapy Response in Resectable Non-Small Cell Lung Cancer
Led by Ruijin Hospital · Updated on 2025-01-01
40
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the usefulness of 68Ga-grazytracer PET/CT scans to early assess how patients with resectable non-small cell lung cancer (NSCLC) respond to neoadjuvant immunotherapy. The study focuses on patients with clinical stage IB-IIIA NSCLC who will undergo standardized immunotherapy before surgery. Accurately measuring the immune response early on is challenging, and this study aims to explore how well this imaging method reflects treatment effects. Participants will receive neoadjuvant immunotherapy every three weeks for three cycles. Those with nonsquamous NSCLC will be treated with pembrolizumab plus platinum-pemetrexed, while patients with lung squamous cell carcinoma will receive pembrolizumab plus platinum-paclitaxel. All patients will undergo 68Ga-grazytracer PET/CT imaging at the start of treatment and prior to the third cycle. This tracer specifically targets granzyme B, showing the activity of immune cells killing the tumor. During the study, patients will be monitored with these PET/CT scans and clinical assessments to measure the pathological response after surgery, within three weeks post-operation. Researchers will compare imaging results and pathological findings to determine the effectiveness of the tracer in reflecting immune response. The study also involves evaluating imaging response categories and collecting safety information to better understand treatment impact and patient outcomes.
CONDITIONS
Official Title
68Ga-grazytracer PET/CT for Early Assessment of Response to Neoadjuvant Immunotherapy in Resectable NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical stage IB to IIIA (AJCC/UICC 8th Edition) before treatment
- Resectable lung cancer confirmed by an experienced surgeon
- Histologically confirmed primary non-small cell lung cancer
- Men and women aged 18 to 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Expected survival of at least 6 months
- Signed informed consent form
You will not qualify if you...
- Diagnosis other than non-small cell lung cancer
- Lung cancer that cannot be surgically removed or has distant metastasis
- Previous cancers except certain skin and in situ cancers unless complete remission was achieved at least 2 years ago with no further therapy needed
- Active or past autoimmune diseases or history requiring systemic steroids or immunosuppressants
- Immunodeficiency conditions such as HIV or active hepatitis B or C
- Uncontrolled diabetes or fasting blood glucose higher than 11.0 mmol/L
- Women who are pregnant or breastfeeding
- History of severe heart disease, severe bone marrow suppression, or severe liver or kidney failure
- History of organ or stem cell transplantation
- Any medical or psychological condition preventing study completion or understanding of study information
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
H
Hecheng Li, MD, PHD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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