A PET Imaging Agent (64Cu-DOTA-Pembrolizumab) for Determining Treatment Response Among Patients With Stage IV Non-small Cell Lung Cancer Receiving Pembrolizumab

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07619599
Phase
PHASE1
Status
Not Yet Recruiting

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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 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Computed Tomography — PROCEDURE
    Undergo CT
  • Copper Cu 64-DOTA-pembrolizumab — RADIATION
    Given IV
  • Low Dose Radiation Therapy — RADIATION
    Undergo LDRT
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET
  • Stereotactic Body Radiation Therapy — RADIATION
    Undergo SBRT

Study Details

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.

Key Dates

Start date
Sep 14, 2026
Status verified
May 2026
Primary completion
Dec 22, 2028
Completion
Dec 22, 2028

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Incidence of treatment-related adverse event rates [ Time Frame: Up to 14 days after 64Cu-DOTA-pembrolizumab infusion ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Sagus Sampath
[email protected]
626-218-8240
Sagus Sampath (PRINCIPAL_INVESTIGATOR)

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City of Hope Medical Center· Duarte, CA

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