New imaging agent may help doctors see which lung tumors are still growing during immunotherapy
NCT ID NCT07619599
First seen Jun 25, 2026 · Last updated Aug 13, 2026 · Updated 3 times
Summary
This early-phase trial will test a new PET imaging agent called 64Cu-DOTA-pembrolizumab in 6 people with stage IV non-small cell lung cancer who are already on the immunotherapy drug pembrolizumab. The goal is to see if the imaging agent can safely tell the difference between tumors that are still growing and those that are stable. Participants will also receive low-dose radiation to some tumors to see how that affects the imaging results.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 64Cu-DOTA-pembrolizumab (a radioactive imaging agent)
- What this could lead to
- If successful, this could give doctors a better way to see which tumors are still growing during immunotherapy, helping guide treatment decisions.
- What could go wrong
- This is a very early, small pilot study with only 6 people. It is designed to test safety and imaging ability, not to change treatment yet. The imaging agent may not clearly distinguish tumor types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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City of Hope Medical Center
RECRUITINGDuarte, California, 91010, United States
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