A PET Imaging Agent (64Cu-DOTA-Pembrolizumab) for Determining Treatment Response Among Patients With Stage IV Non-small Cell Lung Cancer Receiving Pembrolizumab

Starting soon · Phase 1

Conditions studied: Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Oligoprogressive Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

In brief

This phase I trial studies the safety and side effects of a new positron emission tomography (PET) imaging agent called 64Cu-DOTA-pembrolizumab to see how well it works in determining treatment response for patients with stage IV non-small cell lung cancer (NSCLC) already receiving pembrolizumab. 64Cu-DOTA-pembrolizumab consists of a monoclonal antibody, pembrolizumab, that binds to a protein called PD-1 that is expressed on tumor cells. PET scans can then visualize the tumor cells using 64Cu, a radioactive substance. 64Cu-DOTA-pembrolizumab PET scans may be safe and useful to doctors in telling the difference between tumors that are still growing and areas that are not growing in patients with stage IV NSCLC receiving pembrolizumab treatment.

Key facts

Study ID: NCT07619599
Run by: City of Hope Medical Center
People needed: 6
Starts: 2026-09-14
Expected to finish: 2028-12-22
Last updated by the study team: 2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
Age: ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) ≤ 2
Histologically confirmed stage IV non-small cell lung cancer
Patients on single-agent pembrolizumab, who have been referred for SBRT for or oligo-progressive disease. A maximum of 6 sites will be allowed to receive SBRT on protocol
Patients must have sites that are amenable to SBRT that are located in lymph nodes, bone/spine, or lung
Brain metastases or cases with intra-cranial progression are allowed, but an additional extra-cranial site planned for SBRT is required
Absolute neutrophil count (ANC) ≥ 1,000/mm\^3
Platelets ≥ 50,000/mm\^3
NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment
Total bilirubin ≤ 1.5 X upper limit of normal (ULN)
Aspartate aminotransferase (AST) ≤ 3.0 x ULN
Alanine aminotransferase (ALT) ≤ 3.0 x ULN
Creatinine clearance of ≥ 30 mL/min per 24 hour urine test or the Cockcroft-Gault formula
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Agreement by females and males of childbearing potential* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)

You may not qualify if…

Patient planned to stop pembrolizumab at time of referral for SBRT
Vaccination with live attenuated vaccines within 4 weeks of study agent administration except forthcoming coronavirus disease 2019 (COVID-19) and flu vaccines
Subject is currently using or has used immunosuppressive medication within 14 days prior to the study agent administration with the exception of:
Intranasal, topical, inhaled, or local steroid injections (e.g., intra-articular injection)
Chronic systemic corticosteroids at physiologic doses not to exceed 5 mg/day of prednisone or equivalent
Steroids as premedication for hypersensitivity reactions (e.g., infusion-related reactions, CT scan premedication)
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
Clinically significant uncontrolled illness
Infection requiring systemic antibiotic therapy within 14 days prior to start of study treatment
Patient unable to tolerate PET scan even with anxiolytic medications
Other active metastatic malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Females only: Pregnant or breastfeeding
Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Where it is running

City of Hope Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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