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

NCT06756217 | Recruiting

• 1 other identifier: RTS-024
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

68Ga-grazytracer PET/CT DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

NSCLC patients requiring neoadjuvant immunotherapy

You may qualify if:

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

You may not qualify if:

• Histologically confirmed were NOT NSCLC;
• Lung cancer that can not be resected or has distant metastasis, or for other reasons can not tolerate surgery;
• 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;
• 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;
• Uncontrolled diabetes or fasting blood glucose ≥11.0 mmol/L on the day of the test;
• Women who are or may become pregnant, and lactating women are excluded;
• 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;
• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

3-5 tumor samples of typical cases will be collected for flow cytometric analysis and destroyed after test.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Hecheng Li, MD, PHD

CONTACT

021-74370045; lihecheng2000@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 1, 2025
• Study Start: December 30, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)