NCT06756217

68Ga-grazytracer PET/CT for Early Assessment of Response to Neoadjuvant Immunotherapy in Resectable NSCLC

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the effectiveness of 68Ga-grazytracer PET/CT in early evaluation of neoadjuvant immunotherapy response in resectable NSCLC.

Detailed description

It is challenging to noninvasively early evaluate the immunotherapy response of cancer. The study will evaluate the application value of 68Ga-grazytracer PET/CT in the early evaluation of neoadjuvant immunotherapy response in resectable non-small cell lung cancer (NSCLC). Potential participants will be assessed for inclusion, including the verification of clinical stage and eligibility. Eligible patients with clinically stage IB-IIIA NSCLC will be received standardized neoadjuvant immunotherapy (every 3 weeks for 3 cycles). Patients with nonsquamous NSCLC will be received pembrolizumab plus platinum-pemetrexed, and lung squamous cell carcinoma patients will be received pembrolizumab plus platinum-paclitaxel. 68Ga-grazytracer PET/CT imaging will be performed at baseline and before cycle 3. Pathological response of the primary (MPR vs. Non-MPR), imaging response (iPR vs. Non-iPR; MR vs. MD), and 68Ga-grazytracer PET/CT imaging (Positive vs. Negative) will be given special attention.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	68Ga-grazytracer PET/CT	68Ga-grazytracer is designed to target granzyme B, and showed excellent in vivo metabolic stability and favorable targeting efficiency during immune responses. 68Ga-grazytracer PET/CT could directly display the killing effect of CD8+T cells on tumor. All enrolled patients underwent the same 68Ga-grazytracer PET/CT imaging.

Timeline

• Start date: 2024-12-30
• Primary completion: 2026-06-30
• Completion: 2027-12-30
• First posted: 2025-01-01
• Last updated: 2025-01-01

Locations

1 site across 1 country: China