Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New imaging agent may help doctors see which lung tumors are still growing during immunotherapy

NCT ID NCT07619599

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 6 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Metastatic lung non-small cell carcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • City of Hope Medical Center

    RECRUITING

    Duarte, California, 91010, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.