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64Cu-DOTA-Pembrolizumab Imaging for Stage IV Lung Cancer

This study is looking at a new imaging agent called 64Cu-DOTA-pembrolizumab to help doctors understand how well treatment is working for people with stage IV non-small cell lung cancer (NSCLC). If you are already receiving pembrolizumab (a type of immunotherapy), you might be able to join. The study will use PET scans (Positron Emission Tomography) to see if this new agent can help tell the difference between tumors that are still growing and those that are not. Researchers will also be checking for any side effects from the imaging agent. The goal is to see if 64Cu-DOTA-pembrolizumab PET scans can safely and effectively show how your body is responding to pembrolizumab treatment.

Study design
This is an interventional study with a planned enrollment of 6 participants. It is not specified if it is randomized or blinded.
What's involved
You will receive pembrolizumab, then the 64Cu-DOTA-pembrolizumab infusion, followed by a PET scan. You will also undergo CT scans and potentially low dose radiation therapy (LDRT) or SBRT (Stereotactic Body Radiation Therapy).
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be measured for up to 14 days after the 64Cu-DOTA-pembrolizumab infusion. The imaging agent's uptake will be measured on day 2 and day 44.

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NCT07619599

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
City of Hope Medical Center
~6 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Computed TomographyCopper Cu 64-DOTA-pembrolizumabLow Dose Radiation TherapyPembrolizumabPositron Emission TomographyStereotactic Body Radiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-related adverse event rates
Measured over Up to 14 days after 64Cu-DOTA-pembrolizumab infusion
+1 more outcome measured

Conditions

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

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Where it's being run

1 sites across 1 states
California1

Study leadership

  • Sagus Sampath · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Sagus Sampath
[email protected]
626-218-8240
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

Exclusion

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)

What this trial measures

  • Incidence of treatment-related adverse event ratesUp to 14 days after 64Cu-DOTA-pembrolizumab infusion

    Will be assessed by Common Terminology Criteria for Adverse Events version 5.0, delineated by grade and attribution. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.

  • 64Cu-DOTA-pembrolizumab maximum standard uptake value (SUVmax)Day 2 and day 44

    Will evaluate CDP SUVmax at baseline for oligoprogressive lesions(s) versus lesions that are not progressing on pembrolizumab therapy. For this comparison, each patent will have both type of lesion(s) to be eligible. If the patient has more than one oligoprogressive lesion, the median SUVmax over the oligoprogressive lesions will be the key metric. Similarly if the patient has more than one non-oligoprogressive lesion the median SUVmax will be the key metric for that type of lesion within a patient. Only lesions measuring at least 2cm will be considered and if \> 5 lesions, of either class, the target lesions will be identified before the CDP scan and if two qualifying lesions of the two different groups are in the same organ, they will be selected preferentially as the target lesions. As a result for each patient will have an SUVmax for oligoprogressive disease and an SUVmax for non-oligoprogressive disease.