PET/CT Imaging for Lung Cancer

Recruiting at 6 trial locations

Overseen By Alexander Shoushtari, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Pregnant, Breastfeeding, Splenectomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a PET/CT scan can safely and effectively detect certain immune cells in the body using a new imaging agent. The focus is on individuals with metastatic non-small cell lung cancer, a type of lung cancer that has spread. The trial uses a radiotracer called zirconium Zr 89 crefmirlimab berdoxam. Those diagnosed with metastatic non-small cell lung cancer and scheduled to receive a specific cell therapy might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new imaging agent.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that PET/CT imaging with zirconium Zr 89 crefmirlimab berdoxam is safe?

Research shows that zirconium Zr 89 crefmirlimab berdoxam is under study to determine its safety for various conditions, including lung cancer. In studies with patients who have advanced cancers, this imaging agent has generally been well-tolerated. Reported side effects are mostly mild, such as minor reactions at the injection site where the radiotracer is administered.

As this trial is in its early stages, it primarily focuses on assessing safety, resulting in limited information from human studies. However, its testing suggests that earlier research has indicated it to be potentially safe enough to proceed. This imaging agent does not treat cancer but aids in visualizing certain immune cells in the body, reducing the likelihood of severe side effects compared to drug therapies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Zirconium Zr 89 crefmirlimab berdoxam for metastatic non-small cell lung cancer (NSCLC) because it introduces a novel approach to imaging that could enhance diagnosis and monitoring. Unlike standard imaging methods, this treatment uses a radiolabeled antibody, allowing for more precise targeting of cancer cells during PET/CT scans. This precision could potentially lead to earlier detection of metastases and a better understanding of how the cancer responds to treatment, which is a significant advancement over existing imaging techniques.

What evidence suggests that PET/CT imaging is effective for identifying CD8+ T cells in lung cancer?

Research shows that zirconium Zr 89 crefmirlimab berdoxam, which participants in this trial will receive, is under study for its ability to detect CD8+ T cells in advanced non-small cell lung cancer (NSCLC). These T cells, a type of immune cell, can attack cancer. Studies have demonstrated that this imaging agent can make these cells "light up" on PET/CT scans, enhancing visibility. This could help doctors assess how well a patient's immune system responds to cancer treatment. Initial findings suggest it might effectively identify patients who could benefit from certain therapies. Overall, the treatment shows promise in improving how doctors track and manage lung cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Adam Schoenfeld, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with metastatic non-small cell lung cancer who haven't yet received engineered TIL cell therapy. Participants must consent to study requirements, use effective contraception, and not have a history of significant splenic dysfunction or be pregnant/breastfeeding.

Inclusion Criteria

I have been diagnosed with metastatic non-small cell lung cancer.

Patient or legally authorized representative provided signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

I am enrolled in the OBX115-23-01 TIL cell therapy study but haven't started treatment.

Exclusion Criteria

I have had my spleen removed or have significant issues with my spleen.

Pregnant or breastfeeding women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive engineered tumor infiltrating lymphocyte (TIL) therapy and undergo PET/CT scans to assess CD8+ T cell distribution

2 weeks

Multiple visits for PET/CT scans and TIL therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Zirconium Zr 89 crefmirlimab berdoxam

Trial Overview The study tests if PET/CT scans using zirconium Zr 89 crefmirlimab berdoxam can safely and effectively detect CD8+ T cells in patients undergoing treatment for non-small cell lung cancer.

How Is the Trial Designed?

Group I: Participants with Metastatic non-small cell lung cancer (NSCLC) Experimental Treatment 2 Interventions

Participants will have a diagnosis of metastatic non-small cell lung cancer (NSCLC)

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a pilot study of 10 patients with therapy-refractory interstitial pneumonitis treated with rituximab, PET/CT imaging using [89Zr]Zr-rituximab showed increased lung activity in four patients, suggesting potential for this imaging technique to predict treatment response.

One patient experienced a severe allergic reaction to the initial rituximab infusion, but subsequent imaging with [89Zr]Zr-rituximab was well-tolerated, indicating that this imaging method may be safe even after adverse reactions to the full drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[89Zr]Zr-rituximab PET/CT activity in patients with therapy refractory interstitial pneumonitis: a feasibility study. Adams, H., van de Garde, EM., van Moorsel, CH., et al.[2020]

Avelumab, an anti-PD-L1 antibody labeled with zirconium-89, showed high affinity for PD-L1 in cancer cells, indicating its potential for targeted cancer imaging and therapy.

In mouse models, the uptake of the labeled avelumab in PD-L1-expressing tumors increased with higher doses of unlabeled avelumab, suggesting that dose escalation can enhance targeting efficiency in vivo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immuno-PET Imaging of the Programmed Cell Death-1 Ligand (PD-L1) Using a Zirconium-89 Labeled Therapeutic Antibody, Avelumab. Jagoda, EM., Vasalatiy, O., Basuli, F., et al.[2020]

The study demonstrated that [89Zr]-anti-PD-1 immuno-PET is a safe and effective imaging method to assess the response to PD-1 blockade in non-small cell lung cancer (NSCLC), showing higher uptake in responders compared to non-responders.

Conventional imaging methods like [18F]-FDG-PET were unable to detect the anti-tumor effects of PD-1 therapy, highlighting the potential of [89Zr]-anti-PD-1 as a more reliable tool for monitoring treatment response in immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel [89Zr]-anti-PD-1-PET-CT to assess response to PD-1/PD-L1 blockade in lung cancer. Puyalto, A., Rodríguez-Remírez, M., López, I., et al.[2023]

89Zirconium-immuno-PET (89Zr-immuno-PET) can effectively assess tumor uptake of trastuzumab, showing that uptake increases with target concentration before plateauing, which is influenced by the total administered dose of the antibody.

The study highlights the importance of defining clinical target positivity cut-offs, as false-positive results can occur depending on the threshold used for immunohistochemistry scores, particularly when using a standard imaging dose of 50 mg of 89Zr-trastuzumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential and pitfalls of 89Zr-immuno-PET to assess target status: 89Zr-trastuzumab as an example. Huisman, MC., Menke-van der Houven van Oordt, CW., Zijlstra, JM., et al.[2021]

In a study involving 18 patients with advanced melanoma or non-small-cell lung cancer, the uptake of 89Zr-labeled pembrolizumab in tumors was found to correlate with treatment response and patient survival, suggesting it could be a useful predictor of therapy effectiveness.

The optimal dose for 89Zr-pembrolizumab was determined to be 5 mg, with the best imaging results observed on day 7 after administration, indicating a potential timeline for monitoring treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

89Zr-pembrolizumab imaging as a non-invasive approach to assess clinical response to PD-1 blockade in cancer. Kok, IC., Hooiveld, JS., van de Donk, PP., et al.[2022]

89Zr-immuno-PET imaging can help identify cancer patients who are likely to respond to targeted therapies, potentially improving treatment outcomes by ensuring that only those who will benefit receive these therapies.

The use of 89Zr-immuno-PET in conjunction with antibody-drug conjugates (ADCs) allows for better prediction of drug delivery to tumors and helps optimize dosing regimens, enhancing the efficacy and safety of cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Immuno-PET in Antibody-Drug Conjugate Development. Carmon, KS., Azhdarinia, A.[2019]

Immuno-PET using (89)Zr-labeled cmAb U36 demonstrated a sensitivity of 72% for detecting lymph node metastases in head and neck squamous cell carcinoma patients, outperforming conventional imaging methods like CT/MRI in certain aspects.

The accuracy of immuno-PET was 93% for detecting operated lymph node levels, indicating its potential as a reliable diagnostic tool for guiding treatment decisions in patients at high risk for metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of immuno-positron emission tomography with zirconium-89-labeled chimeric monoclonal antibody U36 in the detection of lymph node metastases in head and neck cancer patients. Börjesson, PK., Jauw, YW., Boellaard, R., et al.[2015]

The monoclonal antibody ramucirumab (RAM) was successfully radiolabelled with zirconium-89, allowing for effective targeting and imaging of VEGFR2-positive tumors in prostate and ovarian cancer models.

In vivo studies demonstrated significant uptake of the radiolabelled RAM in tumors, with high tumor-to-muscle ratios observed over several days, indicating its potential for use in imaging and possibly treating angiogenesis-related cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical evaluation of anti-VEGFR2 monoclonal antibody ramucirumab labelled with zirconium-89 for tumour imaging. Novy, Z., Janousek, J., Barta, P., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05013099

NCT05013099 | Study of Zirconium Zr 89 Crefmirlimab ... Evaluate zirconium Zr 89 crefmirlimab berdoxam PET/CT in subjects who develop clinical and/or radiographic progression to explore mechanisms for treatment ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/582615

A Study of CD8+ T Cell Imaging During Treatment in People ... ... Zr 89 crefmirlimab berdoxam is a safe and effective way to identify CD8+ T cells ... metastatic non-small cell lung cancer (NSCLC). Drug. Zirconium Zr 89 ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/study/NCT05013099

Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/​CT ... The purpose of this study is to evaluate whether zirconium Zr 89 crefmirlimab berdoxam (other names 89Zr-crefmirlimab berdoxam, 89Zr-Df-crefmirlimab, ...

4. cancer.gov cancer.gov/clinicaltrials/NCI-2025-02054

A Study of CD8+ T Cell Imaging During Treatment in ... The other part (Zr 89) gives off a small amount of radiation, which “lights up” the CD8+ T cells and makes them easy to see on the PET/CT scan. Tracking the ...

5. withpower.com withpower.com/trial/petct-imaging-for-lung-cancer-119c3

PET/CT Imaging for Lung Cancer This suggests that Zirconium Zr 89 crefmirlimab berdoxam might be effective in identifying patients who could benefit from such treatments.

6. clinicaltrials.eu clinicaltrials.eu/inn/zirconium-89zr-crefmirlimab-berdoxam/

Zirconium (89Zr) Crefmirlimab Berdoxam Clinical trials are investigating its use in various conditions, including non-small cell lung cancer, metastatic solid tumors, rheumatoid arthritis, and giant ...

7. go.drugbank.com go.drugbank.com/drugs/DB19157

Zirconium (89Zr) crefmirlimab berdoxam Zirconium Zr-89 crefmirlimab berdoxam ... Diagnostic, Lung Cancer / Metastatic Non-Small Cell Lung Cancer / Non-Small Cell Lung Cancer (NSCLC) ...

8. onderzoekmetmensen.nl onderzoekmetmensen.nl/en/node/54060/pdf

A Phase IIB, Open Label, Study of Zirconium Zr 89 ... -to assess safety of the repeat zirconium Zr 89 crefmirlimab berdoxam ... advanced or metastatic non-small cell lung cancer without non-smokers/ ...