Using 68Ga-grazytracer PET/CT to assess response to immunotherapy in lung cancer

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

This study is testing if a special type of imaging can help doctors see how well immunotherapy is working for patients with lung cancer before they have surgery.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Ruijin Hospital (other)
• Drugs / interventions: immunotherapy, pembrolizumab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06756217 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of 68Ga-grazytracer PET/CT imaging in the early assessment of response to neoadjuvant immunotherapy in patients with resectable non-small cell lung cancer (NSCLC). Eligible participants will receive standardized immunotherapy treatments and undergo PET/CT imaging at baseline and before the third treatment cycle. The study will focus on determining the pathological and imaging responses to treatment, providing insights into the noninvasive evaluation of immunotherapy effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with clinically staged IB-IIIA resectable non-small cell lung cancer.

Not a fit: Patients with non-resectable lung cancer or those with distant metastasis will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enable earlier and more accurate assessments of treatment responses in lung cancer patients, potentially leading to better treatment decisions.

How similar studies have performed: While the use of PET/CT imaging in cancer assessment is established, the specific application of 68Ga-grazytracer in this context is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Hecheng Li, MD, PHD

Conditions: Non-Small Cell Lung Cancer