Radioligand Therapy for Lung Cancer

Not yet recruiting at 1 trial location

Overseen By Yusuf Menda, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Yusuf Menda

Must not be taking: Cytotoxic, Antineoplastic, Antibody, others

Disqualifiers: Major surgery, Uncontrolled illness, Transplant, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for lung cancer, specifically targeting individuals with atypical carcinoid lesions who have tried other treatments. The trial tests the safety of a new therapy called 212-Lead Pentixather, which involves an injection designed to target cancer cells with radiation. It suits those who have had unsuccessful lung cancer treatments and have at least one tumor measuring 2 cm or larger. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that 212-Lead Pentixather is still in the early stages of human testing, so limited safety information is available. This treatment uses a type of radiation to target cancer cells. As this is its first human trial, researchers aim to determine a safe dose.

In animal studies, the treatment was tested for safety and effectiveness against certain lung cancers. These studies appear promising, but results in animals don't always predict human outcomes. This trial is in its earliest phase, focusing on how well people tolerate the treatment and identifying any side effects. At this stage, researchers begin to gather safety information.

Participants should understand that while early trials are crucial for assessing a treatment's potential, they also involve unknowns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for lung cancer, like chemotherapy and targeted therapies, work by attacking cancer cells directly or interfering with specific molecules that help cancer grow. But 212-Lead Pentixather works differently, using a novel approach called radioligand therapy. This treatment delivers radiation directly to cancer cells through a single intravenous infusion, targeting them with high precision while minimizing damage to surrounding healthy tissue. Researchers are excited because this method could offer a more targeted and potentially less harmful alternative to traditional treatments, providing new hope for better outcomes in lung cancer therapy.

What evidence suggests that 212-Lead Pentixather might be an effective treatment for lung cancer?

Research has shown that 212-Lead Pentixather, the treatment under study in this trial, may help treat lung cancer by targeting a protein called CXCR4, which plays a role in cancer growth. Studies have found that 212-Lead Pentixather can significantly improve survival rates in small cell lung cancer, a type similar to the one being studied. It also aids in bone marrow recovery, which is crucial for blood cell production. These findings suggest that 212-Lead Pentixather could be effective in managing unusual carcinoid growths in the lung. ^{2 6 7 8 9}

Who Is on the Research Team?

Yusuf Menda, MD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I have not received antibody therapy in the last 21 days.

Breastfeeding

Another investigational agent within 4 weeks of consent

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• 203-Lead Pentixather SPECT/CT
• 212-Lead Pentixather

Trial Overview The 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.

How Is the Trial Designed?

Group I: 212-Lead Pentixather Experimental Treatment 2 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.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New administration modalities for radiotherapy in lung cancer]. Touboul, E., Deniaud-Alexandre, E., Pereira, R., et al.[2018]

Citations

1. biorxiv.org biorxiv.org/content/10.1101/2024.09.06.611663v1.full-text

Targeting CXCR4 with [ 212 Pb/ 203 Pb]-Pentixather ... Targeting CXCR4 with [212Pb/203Pb]-Pentixather Significantly Increases Overall Survival in Small Cell Lung Cancer · Discussion · Disclosures.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40605199/

Targeting CXCR4 with 212Pb/203Pb-Pentixather ... Small cell lung cancer (SCLC) has a 6% 5-year overall survival rate. C-X-C chemokine receptor 4 (CXCR4) is an attractive target for theranostic ...

3. meridian.allenpress.com meridian.allenpress.com/radiation-research/article/204/3/173/507421/Targeting-CXCR4-with-212Pb-203Pb-Pentixather

203 Pb-Pentixather Significantly Increases Overall Survival ... Treatment with high-LET alpha emitter 212Pb-pentixather significantly prolonged overall survival, and recovery of mouse bone marrow from 212Pb- ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12214231/

212Pb in targeted radionuclide therapy: a review - PMC Preprint: targeting CXCR4 with [212Pb/203Pb]-pentixather significantly increases overall survival in small cell lung cancer. bioRxiv. 2024 ...

5. clinicaltrials.eu clinicaltrials.eu/inn/pentixather/

Pentixather – Application in Therapy and Current Clinical ... Several clinical trials are currently underway to evaluate the safety and effectiveness of PENTIXATHER in different cancer types: A study using 212Pb- ...

6. reporter.nih.gov reporter.nih.gov/project-details/11198271

Project 2: Targeting CXCR4 and Redox ... - NIH RePORTER ... 212Pb-pent for improving outcomes in currently incurable neuroendocrine lung cancers. Public Health Relevance Statement. Project 2 – Narrative Atypical ...

7. ancora.ai ancora.ai/en/details/NCT05557708

A Safety Study of 212Pb-Pentixather Radioligand Therapy This is a first-in-human clinical trial evaluating the safety of an alpha-radiation treatment (Lead-212 labelled Pentixather) in patients ...

8. clinicaltrial.be clinicaltrial.be/en/details/14493?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

A Safety Study of 212Pb-Pentixather Radioligand Therapy -... This is a study to determine what dose is acceptably safe for further testing. In this study, participants are asked to:.

9. trials.braintumor.org trials.braintumor.org/trials/NCT05557708

A Safety Study of 212Pb-Pentixather Radioligand Therapy This is a first-in-human clinical trial evaluating the safety of an alpha-radiation treatment (Lead-212 labelled Pentixather) in patients who have been ...