Metastatic Lung Non-Small Cell CarcinomaPhase 1NCT07619599
A PET Imaging Agent (64Cu-DOTA-Pembrolizumab) for Determining Treatment Response Among Patients With Stage IV Non-small Cell Lung Cancer Receiving Pembrolizumab
A Phase 1 study testing Computed Tomography, Copper Cu 64-DOTA-pembrolizumab and Low Dose Radiation Therapy in people with Metastatic Lung Non-Small Cell Carcinoma and Metastatic Malignant Neoplasm in the Brain, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Oligoprogressive Lung Non-Small Cell Carcinoma
- What is being tested?
- Computed Tomography, Copper Cu 64-DOTA-pembrolizumab and Low Dose Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 10 Feb 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Sagus Sampath, 626-218-8240, ssampath@coh.org
Sagus Sampath
About this study
Official title: Pilot Study of 64Cu-DOTA Pembrolizumab (64CDP) in Patients Receiving Stereotactic Body Radiation Therapy (SBRT) for Oligo-Progressive Non-Small Cell Lung Cancer (NSCLC)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To describe the safety of administering copper Cu 64-DOTA-pembrolizumab (64Cu-DOTA-pembrolizumab) for PET imaging in patients receiving SBRT for NSCLC during pembrolizumab therapy.
II. Evaluate 64Cu-DOTA-pembrolizumab maximum standard uptake value (SUVmax) at baseline for oligoprogressive lesion(s) versus (vs) lesions that were not progressing on pembrolizumab therapy.
SECONDARY OBJECTIVES:
- Evaluate change in SUVmax in non-progressing lesions given low dose radiation therapy (LDRT).
II. Evaluate change in SUVmax on oligoprogressive lesions treated with SBRT. III. Compare change in SUV-max of 64Cu-DOTA-pembrolizumab (64CDP) from baseline to the follow-up scan on non-progressive lesions not given LDRT or SBRT.
IV. Evaluate the impact of different quantitative measures of PET avidity (e.g. SUVpeak, SUVmean, lean-body weight-adjusted, relative to average uptake in liver).
EXPLORATORY OBJECTIVE:
- To summarize differences in SUVmax pre- and post-SBRT based on tumor location and clinical course for further hypothesis generation.
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 then receive SOC SBRT over 3-5 treatment fractions over a 10-12 day period (approximately days 8-18). 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.
- 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
- Being tested
- Computed Tomography, Copper Cu 64-DOTA-pembrolizumab, Low Dose Radiation Therapy, Pembrolizumab, Positron Emission Tomography
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Copper Cu 64-DOTA-pembrolizumabRadiation
Also called 64Cu-DOTA-pembrolizumab, 64Cu-labeled Pembrolizumab, 64Cu-pembrolizumab, Copper Cu 64 Pembrolizumab
Given IV
Low Dose Radiation TherapyRadiation
Also called Low Dose Radiation
Undergo LDRT
PembrolizumabBiological
Also called BCD-201, GME 751, GME751, Keytruda
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT
| Study group | Role | What they receive |
|---|---|---|
| Treatment (pembrolizumab, 64CDP, SBRT, LDRT) | Experimental | 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. Receives: Procedure: Computed Tomography; Radiation: Copper Cu 64-DOTA-pembrolizumab; Radiation: Low Dose Radiation Therapy; Biological: Pembrolizumab; Procedure: Positron Emission Tomography; Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related adverse event rates
Will be assessed by Common Terminology Criteria for Adverse Events version 5.0, delineated by grade and attribution. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.
Measured: Up to 14 days after 64Cu-DOTA-pembrolizumab infusion
64Cu-DOTA-pembrolizumab maximum standard uptake value (SUVmax)
Will evaluate CDP SUVmax at baseline for oligoprogressive lesions(s) versus lesions that are not progressing on pembrolizumab therapy. For this comparison, each patent will have both type of lesion(s) to be eligible. If the patient has more than one oligoprogressive lesion, the median SUVmax over the oligoprogressive lesions will be the key metric. Similarly if the patient has more than one non-oligoprogressive lesion the median SUVmax will be the key metric for that type of lesion within a patient. Only lesions measuring at least 2cm will be considered and if > 5 lesions, of either class, the target lesions will be identified before the CDP scan and if two qualifying lesions of the two different groups are in the same organ, they will be selected preferentially as the target lesions. As a result for each patient will have an SUVmax for oligoprogressive disease and an SUVmax for non-oligoprogressive disease.
Measured: Day 2 and day 44
Secondary outcomes (6)
Change in SUV-max of 64CDP in non-progressing lesions that were given low dose radiation therapy
T-tests (paired) will be used to test changes in 64-CDP uptake in radiated metastatic lesions pre- and post-stereotactic body radiation therapy (SBRT). Non-parametric tests may also be explored in addition to the t-test.
Measured: Day 2 and day 44
Change in SUV-max of 64CDP in oligoprogressive lesions that were given SBRT
T-tests (paired) will be used to test changes in 64-CDP uptake in radiated metastatic lesions pre- and post-SBRT. Non-parametric tests may also be explored in addition to the t-test.
Measured: Day 2 and day 44
Change in SUV-max of 64CDP in non-progression lesions not given LDRT or SBRT
T-tests (paired) will be used to test changes in 64-CDP uptake in radiated metastatic lesions pre- and post-SBRT. Non-parametric tests may also be explored in addition to the t-test.
Measured: Day 2 and day 44
Change in SUVpeak
T-tests (paired) will be used to test changes in 64-CDP uptake in radiated metastatic lesions pre- and post-SBRT. Non-parametric tests may also be explored in addition to the t-test.
Measured: Day 2 and day 44
Change in SUVmean
T-tests (paired) will be used to test changes in 64-CDP uptake in radiated metastatic lesions pre- and post-SBRT. Non-parametric tests may also be explored in addition to the t-test.
Measured: Day 2 and day 44
Change in lean-body weight-adjusted
T-tests (paired) will be used to test changes in 64-CDP uptake in radiated metastatic lesions pre- and post-SBRT. Non-parametric tests may also be explored in addition to the t-test.
Measured: Day 2 and day 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Sep 2026
- Primary completion10 Feb 2030 (estimated)
- Study completion10 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sagus Sampath, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619599
- Sponsor's protocol ID
- 25261
- Other IDs
- NCI-2026-03734, 25261, P30CA033572
- Status last verified
- Oct 2026
- First submitted
- 26 May 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of 64Cu-DOTA Pembrolizumab (64CDP) in Patients Receiving Stereotactic Body Radiation Therapy (SBRT) for Oligo-Progressive Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT07619599
- Acronym / sponsor ID
- 25261
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 10 Feb 2030 (estimated)
- Study completion
- 10 Feb 2030 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To describe the safety of administering copper Cu 64-DOTA-pembrolizumab (64Cu-DOTA-pembrolizumab) for PET imaging in patients receiving SBRT for NSCLC during pembrolizumab therapy.
II. Evaluate 64Cu-DOTA-pembrolizumab maximum standard uptake value (SUVmax) at baseline for oligoprogressive lesion(s) versus (vs) lesions that were not progressing on pembrolizumab therapy.
SECONDARY OBJECTIVES:
- Evaluate change in SUVmax in non-progressing lesions given low dose radiation therapy (LDRT).
II. Evaluate change in SUVmax on oligoprogressive lesions treated with SBRT. III. Compare change in SUV-max of 64Cu-DOTA-pembrolizumab (64CDP) from baseline to the follow-up scan on non-progressive lesions not given LDRT or SBRT.
IV. Evaluate the impact of different quantitative measures of PET avidity (e.g. SUVpeak, SUVmean, lean-body weight-adjusted, relative to average uptake in liver).
EXPLORATORY OBJECTIVE:
- To summarize differences in SUVmax pre- and post-SBRT based on tumor location and clinical course for further hypothesis generation.
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 then receive SOC SBRT over 3-5 treatment fractions over a 10-12 day period (approximately days 8-18). 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (pembrolizumab, 64CDP, SBRT, LDRT) | Experimental | Procedure: Computed Tomography, Radiation: Copper Cu 64-DOTA-pembrolizumab, Radiation: Low Dose Radiation Therapy, Biological: Pembrolizumab, Procedure: Positron Emission Tomography, Radiation: Stereotactic Body Radiation TherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Documented informed consent of the participant and/or legally authorized representative
- 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
Key exclusion criteria (14 listed)
- 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:
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
- Clinically significant uncontrolled illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Treatment (pembrolizumab, 64CDP, SBRT, LDRT) |
| Copper Cu 64-DOTA-pembrolizumabAlso: 64Cu-DOTA-pembrolizumab, 64Cu-labeled Pembrolizumab, 64Cu-pembrolizumab, Copper Cu 64 PembrolizumabGiven IV | Radiation | Treatment (pembrolizumab, 64CDP, SBRT, LDRT) |
| Low Dose Radiation TherapyAlso: Low Dose RadiationUndergo LDRT | Radiation | Treatment (pembrolizumab, 64CDP, SBRT, LDRT) |
| PembrolizumabAlso: BCD-201, GME 751, GME751, KeytrudaGiven IV | Biological | Treatment (pembrolizumab, 64CDP, SBRT, LDRT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET | Procedure or surgery | Treatment (pembrolizumab, 64CDP, SBRT, LDRT) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo SBRT | Radiation | Treatment (pembrolizumab, 64CDP, SBRT, LDRT) |
Primary outcome
Incidence of treatment-related adverse event rates
Time frame: Up to 14 days after 64Cu-DOTA-pembrolizumab infusion
Will be assessed by Common Terminology Criteria for Adverse Events version 5.0, delineated by grade and attribution. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.
64Cu-DOTA-pembrolizumab maximum standard uptake value (SUVmax)
Time frame: Day 2 and day 44
Will evaluate CDP SUVmax at baseline for oligoprogressive lesions(s) versus lesions that are not progressing on pembrolizumab therapy. For this comparison, each patent will have both type of lesion(s) to be eligible. If the patient has more than one oligoprogressive lesion, the median SUVmax over the oligoprogressive lesions will be the key metric. Similarly if the patient has more than one non-oligoprogressive lesion the median SUVmax will be the key metric for that type of lesion within a patient. Only lesions measuring at least 2cm will be considered and if > 5 lesions, of either class, the target lesions will be identified before the CDP scan and if two qualifying lesions of the two different groups are in the same organ, they will be selected preferentially as the target lesions. As a result for each patient will have an SUVmax for oligoprogressive disease and an SUVmax for non-oligoprogressive disease.
6 secondary outcomes
Change in SUV-max of 64CDP in non-progressing lesions that were given low dose radiation therapy
Time frame: Day 2 and day 44
Change in SUV-max of 64CDP in oligoprogressive lesions that were given SBRT
Time frame: Day 2 and day 44
Change in SUV-max of 64CDP in non-progression lesions not given LDRT or SBRT
Time frame: Day 2 and day 44
Change in SUVpeak
Time frame: Day 2 and day 44
Change in SUVmean
Time frame: Day 2 and day 44
Change in lean-body weight-adjusted
Time frame: Day 2 and day 44
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sagus Sampath principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Computed Tomography, Copper Cu 64-DOTA-pembrolizumab and Low Dose Radiation Therapy in people with Metastatic Lung Non-Small Cell Carcinoma and Metastatic Malignant Neoplasm in the Brain, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-related adverse event rates (time frame: Up to 14 days after 64Cu-DOTA-pembrolizumab infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.