RYZ101 + Standard Treatments for Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+26 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: RayzeBio, Inc.

Must be taking: Carboplatin, Etoposide, Atezolizumab

Must not be taking: Antibiotics, Vaccines

Disqualifiers: Autoimmune disease, Severe infection, Cardiovascular disease, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on antibiotics or have recently had a live vaccine, you may need to wait before starting the trial.

What data supports the effectiveness of the drug combination RYZ101, Atezolizumab, Carboplatin, and Etoposide for treating small cell lung cancer?

Research shows that adding atezolizumab to carboplatin and etoposide significantly improves survival in patients with extensive-stage small cell lung cancer compared to chemotherapy alone. This combination is well-tolerated and has become a standard treatment option. ^{1 2 3 4 5}

Is the combination of RYZ101 and standard treatments for small cell lung cancer safe for humans?

The combination of atezolizumab (Tecentriq) with carboplatin and etoposide has been generally well tolerated in patients with extensive-stage small cell lung cancer, with no new safety concerns beyond those known for the individual drugs. Common side effects include blood-related issues, skin rash, and low thyroid function, but it did not negatively affect patients' quality of life. ^{1 3 5 6 7}

What makes the drug RYZ101 combined with standard treatments unique for small cell lung cancer?

The drug RYZ101 combined with standard treatments for small cell lung cancer is unique because it includes atezolizumab, an immune checkpoint inhibitor that has been shown to improve survival when added to the traditional chemotherapy regimen of carboplatin and etoposide. This combination represents a newer approach that enhances the body's immune response against cancer cells, offering a significant advancement over previous treatments that relied solely on chemotherapy. ^{3 5 8 9 10}

Eligibility Criteria

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.

Inclusion Criteria

Able to read and/or understand the details of the study and provide written informed consent prior to any study-specific assessments and procedures commence

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

WOCBP must have a negative serum pregnancy test within 48 hours prior to the first dose of study drug and agree to use barrier contraception and a second form of highly effective contraception or total abstinence

Exclusion Criteria

I have not received a live vaccine in the last 4 weeks.

I am unable or unwilling to follow the study's requirements.

I have an autoimmune disease or symptoms suggesting one.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RYZ101 in combination with standard of care therapy (carboplatin + etoposide + atezolizumab)

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

50 months

Treatment Details

Interventions

• Atezolizumab (Monoclonal Antibodies)
• Carboplatin (Other)
• Etoposide (Other)
• RYZ101 (Other)

Trial Overview 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.

Participant Groups

Group I: RYZ101 + SoC Experimental Treatment 7 Interventions

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

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

🇪🇺 Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UCSF San Francisco, CA

Profound Research LLC / MHP Radiation Oncology Institute Troy, MI

Corewell-Health BAMF Health Grand Rapids, MI

Research Facility Los Angeles, CA

More Trial Locations

Who Is Running the Clinical Trial?

RayzeBio, Inc. Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Real-world data of atezolizumab plus carboplatin and etoposide in elderly patients with extensive-disease small-cell lung cancer. [2023] The aim of this study was to assess the effectiveness and tolerability of atezolizumab plus carboplatin and etoposide combination chemotherapy in elderly patients with extensive-disease (ED) small-cell lung cancer (SCLC).

2. United States pubmed.ncbi.nlm.nih.gov

Study: Atezolizumab Improves Survival in SCLC. [2019] Combining the PD-L1 inhibitor atezolizumab with platinum-based chemotherapy improves overall survival among patients with extensive-stage small cell lung cancer relative to chemotherapy alone. These findings could lead to a new first-line treatment option for patients with the disease.

3. New Zealand pubmed.ncbi.nlm.nih.gov

Atezolizumab: A Review in Extensive-Stage SCLC. [2021] Atezolizumab (Tecentriq®), a fully humanized, monoclonal anti-programmed cell death ligand-1 (PD-L1) antibody, is the first immune checkpoint inhibitor to be approved, in combination with carboplatin and etoposide, for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Approval was based on primary data from the multinational phase I/III IMpower133 trial in PD-L1-unselected patients with previously untreated ES-SCLC. In this trial, induction therapy with atezolizumab plus carboplatin and etoposide followed by maintenance therapy with atezolizumab alone significantly prolonged overall survival (OS) and progression-free survival (PFS) compared with carboplatin and etoposide alone. The addition of atezolizumab to chemotherapy was generally well tolerated, with no new safety signals being identified beyond those previously reported for the individual agents. The most common grade 3-4 treatment-related adverse events with this regimen were haematological; the most common immune-related adverse events included rash and hypothyroidism. Importantly, the addition of atezolizumab to chemotherapy improved survival outcomes without adversely impacting patient-reported health-related quality of life (HRQOL). Thus, atezolizumab in combination with carboplatin plus etoposide has emerged as a valuable option for the first-line treatment of ES-SCLC and is being accepted as a standard of care in this setting.

4. Germany pubmed.ncbi.nlm.nih.gov

Atezolizumab addition to platinum doublet: evaluating survival outcomes for patients with extensive disease small cell lung cancer. [2023] The efficacy of adding atezolizumab to the platinum doublet regimen for extensive disease small cell lung cancer (ED-SCLC) remains marginally limited.

5. China pubmed.ncbi.nlm.nih.gov

Clinical outcomes of atezolizumab in combination with etoposide/platinum for treatment of extensive-stage small-cell lung cancer: A real-world, multicenter, retrospective, controlled study in China. [2022] Atezolizumab along with chemotherapy has prolonged the survival of patients with extensive-stage small-cell lung cancer (ES-SCLC) worldwide, although real-world (RW) data are lacking in China. This study was designed to evaluate the efficacy and clinical outcomes of atezolizumab plus etoposide/platinum (EP).

6. United States pubmed.ncbi.nlm.nih.gov

Atezolizumab as the First Systemic Therapy Approved for Alveolar Soft Part Sarcoma. [2023] The objective was to review the pharmacology, efficacy, and safety of atezolizumab (Tecentriq) for the treatment of adult and pediatric patients aged 2 years and older with unresectable or metastatic alveolar soft part sarcoma (ASPS).

7. New Zealand pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. [2019] Atezolizumab (Tecentriq™)-a monoclonal antibody targeting programmed death ligand 1 (PD-L1 or CD274 antigen)-is being developed by Genentech as treatment for a variety of haematological malignancies and solid tumours. It been approved in the US as a second-line therapy for urothelial carcinoma and is awaiting approval as a second-line therapy for non-small cell lung cancer. This article summarizes the milestones in the development of atezolizumab leading to this first approval for urothelial carcinoma.

8. United States pubmed.ncbi.nlm.nih.gov

SKYSCRAPER-02: Tiragolumab in Combination With Atezolizumab Plus Chemotherapy in Untreated Extensive-Stage Small-Cell Lung Cancer. [2023] The phase III SKYSCRAPER-02 study determined whether the benefits of atezolizumab plus carboplatin and etoposide (CE) could be enhanced by the addition of tiragolumab in untreated extensive-stage small-cell lung cancer (ES-SCLC). We report final progression-free survival (PFS) and overall survival (OS) analyses.

9. England pubmed.ncbi.nlm.nih.gov

Safety, pharmacokinetics, and efficacy of budigalimab with rovalpituzumab tesirine in patients with small cell lung cancer. [2022] Agents targeting programmed cell death protein 1 (PD-1) have been approved as monotherapy for patients with small cell lung cancer (SCLC). In preclinical models, the combined targeting of PD-1 and delta-like protein 3 resulted in enhanced antitumor activity. Herein, we report results from the expansion arm of study NCT03000257 evaluating the combination of the anti-PD-1 antibody budigalimab and the targeted antibody-drug conjugate rovalpituzumab tesirine (Rova-T) in patients with previously treated SCLC.

10. India pubmed.ncbi.nlm.nih.gov

First-line immune-checkpoint inhibitor treatment in extensive-disease small-cell lung cancer: A classical and network meta-analysis. [2023] Small-cell lung cancer (SCLC) has a poor prognosis. For the last 30 years, first-line systemic treatment has remained unaltered. After the integration of ımmunotherapy, a new first-line gold standard, atezolizumab in combination with carboplatin plus etoposide, was approved in extensive-disease SCLC (ED-SCLC) in 2019.