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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Diagnostic test: 68Ga-grazytracer PET/CT

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Hecheng Li, MD, PHD; Phone Number: 021-74370045; Email: lihecheng2000@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Hecheng Li, MD, PHD; Phone Number: 021-64370045; Email: lihecheng2000@hotmail.com
      • Principal Investigator: Hecheng Li, MD, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

NSCLC patients requiring neoadjuvant immunotherapy

Description

Inclusion Criteria:

1. Pre-treatment stage as clinical IB-IIIA (AJCC/UICC 8th Edition);
2. Curative resectability has to be explicitly verified by the experienced surgical investigator;
3. Histologically confirmed diagnosis of primary non-small lung cancer.
4. Men and women aged 18 Years to 75 Years;
5. Eastern Cooperative Oncology Group (ECOG) performance status: 0-1;
6. expected survival ≥ 6 months;
7. Sign on the informed consent form (ICF).

Exclusion Criteria:

1. Histologically confirmed were NOT NSCLC;
2. Lung cancer that can not be resected or has distant metastasis, or for other reasons can not tolerate surgery;
3. Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colorectal, endometrial, cervical, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period;
4. Any active or history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications. The subjects were innate or acquired immunodeficiency (such as HIV), or active hepatitis (hepatitis B reference: HBsAg) positive; Hepatitis C reference: HCV antibody positive;
5. Uncontrolled diabetes or fasting blood glucose ≥11.0 mmol/L on the day of the test;
6. Women who are or may become pregnant, and lactating women are excluded;
7. Having a history of severe cardiovascular disease, severe myelosuppression and severe hepatic and renal insufficiency. Having a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
8. Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Pathological Response (MPR)	Defined as the incidence rate in postoperative pathology where the percentage of surviving tumor cells in the tumor bed is ≤ 10%, regardless of the presence or absence of live tumor cells in the lymph nodes.	MPR will be assessed within 3 weeks after surgery

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: December 25, 2024
• First Submitted That Met QC Criteria: December 25, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 25, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: RTS-024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No