A PET Imaging Agent (64Cu-DOTA-Pembrolizumab) for Determining Treatment Response Among Patients With Stage IV Non-small Cell Lung Cancer Receiving Pembrolizumab
Pilot Study of 64Cu-DOTA Pembrolizumab (64CDP) in Patients Receiving Stereotactic Body Radiation Therapy (SBRT) for Oligo-Progressive Non-Small Cell Lung Cancer (NSCLC)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 1 year
- Procedures mentioned: PET scans, CT scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "OUTLINE: Patients receive standard of care (SOC) pembrolizumab intravenously (IV) on day 0, followed by 64Cu-DOTA-pembrolizumab IV over 5 minutes on day 1 and PET scan on day 2."
- "Patients may also undergo low-dose radiation therapy (LDRT) over 3-5 treatment fractions over this 10-12 day period based on results of first 64CDP PET scan."
- "Patients then receive SOC pembrolizumab IV on day 21 and 42, followed by 64Cu-DOTA-pembrolizumab IV over 5 minutes on day 43 and PET scan on day 44."
- "Patients also undergo a computed tomography (CT) scan on study."
- "After completion of study treatment, patients are followed for 1 year."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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)
Study sites (1)
CA
- City of Hope Medical Center · Duarte, CA 91010Sagus Sampath · Study contact · 626-218-8240 · ssampath@coh.orgSagus Sampath · Principal investigatorMore trials in Duarte