20 Participants Needed

Radioligand Therapy for Lung Cancer

KB
Yusuf Menda | University of Iowa Health ...
Overseen ByYusuf Menda, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial is testing a new radiation treatment for lung cancer patients who have not responded well to previous treatments. The treatment uses a drug to deliver radiation directly to the cancer cells, aiming to kill them more effectively.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had cytotoxic or antineoplastic therapy within 21 days of consent (42 days for certain drugs) or antibody therapy within 21 days. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment 203-Lead Pentixather SPECT/CT, 212-Lead Pentixather for lung cancer?

Radioligand therapy, which includes treatments similar to 203-Lead Pentixather SPECT/CT, 212-Lead Pentixather, has shown promise in treating various cancers by targeting specific molecules in cancer cells. Alpha radioligand therapies, like those used in prostate and neuroendocrine cancers, have demonstrated high effectiveness due to their ability to deliver targeted radiation to cancer cells, suggesting potential benefits for lung cancer treatment as well.12345

What makes the treatment 212-Lead Pentixather unique for lung cancer?

212-Lead Pentixather is a type of radioligand therapy that uses alpha particles to target and destroy cancer cells with high precision, potentially offering greater effectiveness and fewer side effects compared to traditional treatments. This approach is novel because it delivers radiation directly to cancer cells, minimizing damage to surrounding healthy tissue.15678

Research Team

Yusuf Menda | University of Iowa Health ...

Yusuf Menda, MD

Principal Investigator

University of Iowa

Eligibility Criteria

This trial is for patients with atypical carcinoid lung lesions who've tried or declined other treatments. They must have a lesion ≥2 cm that's positive for CXCR4, can consent independently, and have good liver and kidney function. People with recent major surgery, other recent therapies, pregnant or breastfeeding women, those not using birth control, or with uncontrolled illnesses are excluded.

Inclusion Criteria

I can make my own medical decisions.
My liver tests are within the required limits.
I have a tumor larger than 2 cm that is positive for CXCR4.
See 3 more

Exclusion Criteria

I have not received antibody therapy in the last 21 days.
Breastfeeding
Another investigational agent within 4 weeks of consent
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dosimetry and Imaging

Participants undergo SPECT/CT imaging with Lead-203 Pentixather and serial blood sampling for dosimetry calculations

1-2 weeks
1 visit (in-person)

Treatment

Participants receive up to 2 infusions of Lead-212 Pentixather, with 6 weeks between each infusion, and kidney protectant infusions

12 weeks
2 visits (in-person)

Follow-up

Participants undergo imaging at 3 months post-treatment to determine disease response

3 months
1 visit (in-person)

Treatment Details

Interventions

  • 203-Lead Pentixather SPECT/CT
  • 212-Lead Pentixather
Trial OverviewThe study tests a new alpha-radiation treatment called Lead-212 labelled Pentixather on patients who've had previous treatments for lung carcinoid tumors. It also uses Lead-203 Pentixather SPECT/CT imaging to identify suitable lesions before treatment.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 212-Lead PentixatherExperimental Treatment2 Interventions
Single intravenous infusion of Pentixather radiolabeled with Lead-212. Administered activity to participant is calculated from bone marrow and renal radiation constraints. Treatment is administered in 2 cycles with 6 weeks between the cycles.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yusuf Menda

Lead Sponsor

Trials
3
Recruited
70+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Holden Comprehensive Cancer Center

Collaborator

Trials
27
Recruited
710+

Findings from Research

Recent advancements in radiotherapy for lung cancer include various administration methods, such as hyperfractionated and accelerated radiotherapy, which aim to improve treatment efficacy while minimizing damage to healthy tissues.
The use of radiosensitizing agents, like 5-fluorouracil and platinum salts, alongside radiotherapy has shown promise in enhancing treatment outcomes for both non-small-cell and small-cell lung cancer.
[New administration modalities for radiotherapy in lung cancer].Touboul, E., Deniaud-Alexandre, E., Pereira, R., et al.[2018]

References

Commercial and business aspects of alpha radioligand therapeutics. [2023]
Clinical Pharmacology of Radiotheranostics in Oncology. [2023]
3.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Applications of 211At and 223Ra in targeted alpha-particle radiotherapy. [2022]
Bronchoscopic brachytherapy. [2007]
Clinical Translation of Targeted α-Therapy: An Evolution or a Revolution? [2023]
[New administration modalities for radiotherapy in lung cancer]. [2018]
Schedule-dependent pulsed paclitaxel radiosensitization for thoracic malignancy. [2019]
Thoracic radiation therapy and concomitant low-dose daily paclitaxel in non-small cell lung cancer: a phase I study. [2015]