Recruiting
Phase 1

64Cu-DOTA-Pembrolizumab

Sponsor:

City of Hope Medical Center

Code:

NCT07619599

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Computed Tomography

Copper Cu 64-DOTA-pembrolizumab

Low Dose Radiation Therapy

Pembrolizumab

Positron Emission Tomography

Study Details

Brief summary:

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.

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

Study ID

NCT07619599

Start date

Sep 14, 2026

Status verified date

Aug, 2026

Completion date

Dec 22, 2028

Anticipated

Primary completion date

Dec 22, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (pembrolizumab, 64CDP, SBRT, LDRT)

Patients receive SOC pembrolizumab IV on day 0, followed by 64Cu-DOTA-pembrolizumab IV over 5 minutes on day 1 and PET scan on day 2. Patients then receive SOC SBRT over 3-5 treatment fractions over a 10-12 day period (approximately days 8-18). Patients may also undergo 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 CT scan on study.

Interventions

Computed Tomography

Undergo CT

Copper Cu 64-DOTA-pembrolizumab

Given IV

Low Dose Radiation Therapy

Undergo LDRT

Pembrolizumab

Given IV

Positron Emission Tomography

Undergo PET

Stereotactic Body Radiation Therapy

Undergo SBRT

Primary outcome measure

  • Incidence of treatment-related adverse event rates [ Time Frame: Up to 14 days after 64Cu-DOTA-pembrolizumab infusion ]
  • 64Cu-DOTA-pembrolizumab maximum standard uptake value (SUVmax) [ Time Frame: Day 2 and day 44 ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Sagus Sampath

626-218-8240ssampath@coh.org

Principal Investigator:

Sagus Sampath

More Information

Sponsor

City of Hope Medical Center

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-08-12.