What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, radiotherapy, and immunotherapy. Chemotherapy with etoposide and platinum-based drugs (carboplatin or cisplatin) often causes side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infection due to lowered blood cell counts. Radiotherapy can lead to skin irritation, fatigue, esophagitis, and lung inflammation. Immunotherapy may cause immune-related side effects like rash, diarrhea, and inflammation of organs such as the lungs, liver, and endocrine glands. Alpha-radiation treatments, like Lead-212 labelled Pentixather, may have side effects including localized pain, fatigue, and potential damage to surrounding tissues due to the high energy of alpha particles.

What prior FDA approvals exist?

The FDA has approved several treatments for Small Cell Lung Cancer (SCLC), primarily focusing on chemotherapy and immunotherapy. Commonly used chemotherapy regimens include etoposide combined with either cisplatin or carboplatin. Immunotherapy options such as atezolizumab and nivolumab have also been approved, often in combination with chemotherapy. While specific alpha-radiation treatments like Lead-212 labelled Pentixather are not mentioned, the general approach to SCLC treatment involves systemic chemotherapy and, more recently, the addition of immune checkpoint inhibitors.

What other types of research exist?

Promising novel alternatives for Small Cell Lung Cancer (SCLC) patients in 2024 include checkpoint inhibitors such as atezolizumab, antibody-drug conjugates, PARP inhibitors, epigenetic inhibitors/innate immune activators, and inhibitors of RNA polymerase II. These treatments are part of ongoing research and have shown potential in improving outcomes for SCLC patients.

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Radioisotope Therapy

Radioligand Therapy for Lung Cancer

Q: What is the mechanism of action of this treatment?

The most common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, radiotherapy, and immunotherapy. Chemotherapy drugs like etoposide, cisplatin, and carboplatin damage the DNA of cancer cells, preventing their division and growth. Radiotherapy uses high-energy radiation to kill or inhibit the growth of cancer cells. Immunotherapy, such as PD-1/PD-L1 inhibitors, enhances the immune system's ability to recognize and attack cancer cells. The trial involving Lead-212 labelled Pentixather, an alpha-radiation treatment, delivers targeted radiation to cancer cells, causing double-strand DNA breaks and leading to cell death. This targeted approach is crucial for SCLC patients as it aims to effectively treat the cancer while minimizing damage to healthy tissues.

Phase < 1

Waitlist Available

Led By Yusuf Menda, MD

Research Sponsored by Yusuf Menda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to provide independent consent

Have at least one lesion ≥ 2 cm that is positive for CXCR4 as demonstrated by Lead-203 Pentixather SPECT/CT

Must not have

Cytotoxic or antineoplastic therapy within 21 days of consent (42 days for nitrosoureas)

Prior solid organ transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

As this is a first-in-human trial of an alpha-radiation therapy, potential side effects may include radiation-related symptoms such as nausea and fatigue; however specific side effects will be monitored closely given the novel nature of the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can make my own medical decisions.

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I have a tumor larger than 2 cm that is positive for CXCR4.

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My liver tests are within the required limits.

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My kidneys work well enough (creatinine clearance ≥ 50 mL/min).

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My initial cancer treatment didn't work or I chose not to continue treatments.

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My blood tests show enough platelets, hemoglobin, and neutrophils.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had cancer-killing drug treatments in the last 3 weeks.

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I have had a solid organ transplant.

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I do not have any severe illnesses that would interfere with the study.

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I have not had major surgery in the last 4 weeks.

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I have not had a bone marrow or stem cell transplant in the last 84 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the recommended phase 2 dose of 212-Lead Pentixather

Secondary study objectives

Cognitive Therapy

Neoplasms

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, radiotherapy, and immunotherapy. Chemotherapy drugs like etoposide, cisplatin, and carboplatin damage the DNA of cancer cells, preventing their division and growth. Radiotherapy uses high-energy radiation to kill or inhibit the growth of cancer cells. Immunotherapy, such as PD-1/PD-L1 inhibitors, enhances the immune system's ability to recognize and attack cancer cells. The trial involving Lead-212 labelled Pentixather, an alpha-radiation treatment, delivers targeted radiation to cancer cells, causing double-strand DNA breaks and leading to cell death. This targeted approach is crucial for SCLC patients as it aims to effectively treat the cancer while minimizing damage to healthy tissues.

Early versus late chest radiotherapy for limited stage small cell lung cancer.