NCT07619599 · City of Hope Medical Center
A PET Imaging Agent (64Cu-DOTA-Pembrolizumab) for Determining Treatment Response Among Patients With Stage IV Non-small Cell Lung Cancer Receiving Pembrolizumab
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Computed Tomography
Undergo CT
RADIATION
Copper Cu 64-DOTA-pembrolizumab
Given IV
RADIATION
Low Dose Radiation Therapy
Undergo LDRT
BIOLOGICAL
Pembrolizumab
Given IV
PROCEDURE
Positron Emission Tomography
Undergo PET
RADIATION
Stereotactic Body Radiation Therapy
Undergo SBRT
Primary outcome measures
Incidence of treatment-related adverse event rates
Time frame: Up 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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
- Duarte, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 12, 2026 · Source of record for eligibility and locations