What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer (SCLC) such as carboplatin, etoposide, and atezolizumab have several known side effects. Carboplatin and etoposide, both chemotherapeutic agents, can cause nausea, vomiting, hair loss, fatigue, and an increased risk of infection due to lowered white blood cell counts. Atezolizumab, an immune checkpoint inhibitor, can lead to immune-related side effects including fatigue, rash, diarrhea, and potential inflammation of organs such as the lungs (pneumonitis) and liver (hepatitis). Combining these treatments may increase the likelihood and severity of these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Small Cell Lung Cancer (SCLC), including chemotherapy agents like carboplatin and etoposide, often used in combination with immunotherapy drugs such as atezolizumab. While somatostatin receptor targeting agents are more commonly associated with neuroendocrine tumors, there is ongoing research, such as the RYZ101 trial, exploring their potential in SCLC. This trial combines a somatostatin receptor targeting agent with standard chemotherapy and immunotherapy, reflecting a novel approach in SCLC treatment.

What other types of research exist?

Promising novel alternatives to RYZ101 for Small Cell Lung Cancer patients include multitargeted kinase inhibitors like regorafenib, cabozantinib, sorafenib, and lenvatinib. These agents target VEGFR and other kinases and have shown some activity in advanced cancers. Additionally, clinical trials investigating new systemic agents and combination therapies may offer potential options.

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Monoclonal Antibodies

RYZ101 + Standard Treatments for Small Cell Lung Cancer

Phase 1

Recruiting

Research Sponsored by RayzeBio, Inc.

Eligibility Criteria Checklist

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

Must have

Candidate for therapy with SoC including Carboplatin for a maximum of 4 cycles, Etoposide for a maximum of 4 cycles, Atezolizumab

Adequate hepatic function with Total bilirubin ≤1.5 × ULN, Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤2.5 × ULN

Must not have

Known active or suspected autoimmune disease, including paraneoplastic syndromes of autoimmune nature

Contraindication to receive carboplatin or etoposide

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 50 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, RYZ101, combined with standard cancer treatments in patients with a specific type of untreated lung cancer. The new drug aims to target certain receptors on cancer cells, while the other drugs work to kill the cancer cells and help the immune system fight them.

Who is the study for?

This trial is for adults with untreated ES-SCLC that expresses somatostatin receptors. Participants must have adequate organ function, no severe allergies to certain drugs or cell products, and not be pregnant or breastfeeding. They should not have had major surgery recently, active infections like TB or hepatitis, significant heart disease, other cancers in the last 3 years (with some exceptions), or a history of severe allergic reactions.

What is being tested?

The study tests RYZ101 at various doses combined with standard chemotherapy (carboplatin + etoposide) and immunotherapy (atezolizumab) in patients with SSTR+ ES-SCLC. It aims to assess safety, how well it works against cancer cells, and how the body processes the drug.

What are the potential side effects?

Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss; immunotherapy-related issues like inflammation of organs; infusion reactions from antibodies; blood disorders; increased risk of infection due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

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

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I am eligible for standard cancer treatment including Carboplatin, Etoposide, and Atezolizumab.

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My liver tests are within normal limits.

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My small cell lung cancer is confirmed and I've had at most one treatment with specific drugs.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My scans show a positive result for a specific cancer marker and at least half of my cancer spots can be measured.

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My blood counts meet the required levels for treatment.

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My kidneys work well, with a creatinine clearance rate of 60 mL/min or higher.

Exclusion Criteria

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

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I have an autoimmune disease or symptoms suggesting one.

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I cannot take carboplatin or etoposide due to health reasons.

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I have brain metastases from cancer and am still experiencing side effects from radiotherapy.

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I have had a previous transplant of stem cells or an organ.

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I do not have active infections like TB, hepatitis B or C, or HIV, nor am I on antiviral therapy for HBV.

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I do not have serious heart disease or a long QT interval.

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My high blood pressure doesn't improve with medication.

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I have a history of lung scarring or inflammation not caused by infections.

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I have undergone peptide receptor radionuclide therapy.

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I am allergic to certain medical imaging agents or their components.

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I have had or will have chest radiation before systemic therapy or had significant radiation to my bone marrow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 50 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 50 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 50 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

RP2D

Safety and tolerability of RYZ101 in combination with SoC

Secondary study objectives

BOR

DOR

Disease Control Rate

+10 more

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: RYZ101 + SoCExperimental Treatment7 Interventions

RYZ101 (Actinium 225 radiolabeled somatostatin analog (SSA)) 6.5 MBq/175 μCi in combination with standard of care (SoC) carboplatin + etoposide + atezolizumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5850

Etoposide

2010

Completed Phase 3

~2960

Carboplatin

2014

Completed Phase 3

~6120

0 / 18Eligibility 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 regimens such as etoposide combined with either cisplatin or carboplatin. These agents work by damaging the DNA of cancer cells, thereby inhibiting their ability to replicate and leading to cell death. Additionally, immune checkpoint inhibitors like atezolizumab, which target PD-L1, help the immune system recognize and attack cancer cells. Emerging treatments, such as the somatostatin receptor targeting agent RYZ101, aim to deliver cytotoxic agents directly to cancer cells expressing somatostatin receptors, potentially increasing treatment efficacy while minimizing damage to healthy cells. These mechanisms are crucial for SCLC patients as they offer targeted approaches that can improve outcomes and reduce side effects compared to traditional therapies.

Current and evolving treatment options for limited stage small cell lung cancer.