What side effects are associated with this type of intervention?

The most common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy regimens such as carboplatin and etoposide, often combined with PD-1 inhibitors like Serplulimab or Atezolizumab. Common side effects of these treatments include nausea, vomiting, fatigue, hair loss, and an increased risk of infection due to lowered white blood cell counts. PD-1 inhibitors can also cause immune-related side effects such as skin reactions, endocrine disorders, and pneumonitis. Serious adverse events, though less common, may include severe pneumonia, diarrhea, and infusion-related reactions.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of Small Cell Lung Cancer (SCLC), particularly in combination with chemotherapy. Atezolizumab, a PD-L1 inhibitor, was approved for use with carboplatin and etoposide as a first-line treatment for extensive-stage SCLC. Similarly, Durvalumab, another PD-L1 inhibitor, has been approved in combination with platinum-etoposide chemotherapy for the same indication. These approvals highlight the growing role of immunotherapy, specifically PD-1 and PD-L1 inhibitors, in the management of SCLC.

What other types of research exist?

Promising alternatives to Serplulimab for Small Cell Lung Cancer patients include Atezolizumab (a PD-L1 inhibitor) combined with chemotherapy, as it has been used in clinical trials and shown efficacy. Additionally, Nivolumab (a PD-1 inhibitor) has demonstrated effectiveness in various studies and could be considered a viable option.

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Monoclonal Antibodies

Serplulimab + Chemotherapy for Small Cell Lung Cancer

Verified Trial

Phase 3

Recruiting

Research Sponsored by Shanghai Henlius Biotech

Eligibility Criteria Checklist

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

Must have

You have been newly diagnosed with extensive- stage small cell lung cancer

You have full mobility even with current symptoms

Must not have

I have recieved treatment for my small cell lung cancer (radiation, chemotherapy, immunotherapy)

I have tested positive for HIV, Hepatitis B, or Hepatitis C.

Timeline

Screening 28 days

Treatment 5 months

Follow Up 60 months

Awards & highlights

Verified Trial Data

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing two different treatment combinations for patients with extensive-stage small cell lung cancer who have not received any prior treatment. One group will receive a new drug called Serplulimab along with standard chemotherapy, while the other group will receive an existing drug called Atezolizumab with the same chemotherapy. Both immunotherapy drugs aim to help the immune system fight cancer, and the chemotherapy drugs work by killing cancer cells. Atezolizumab has been shown to improve survival in small-cell lung cancer when combined with chemotherapy, changing the standard first-line therapy.

Who is the study for?

This trial is for US patients newly diagnosed with extensive-stage small cell lung cancer (ES-SCLC) who are fully mobile and have not received prior treatment. Eligible participants must not have other active cancers, except certain cured skin or in situ cancers, and should test negative for HIV, Hepatitis B/C. They cannot join if they've had a solid organ or bone marrow transplant, cervical/bladder/skin cancer, peripheral neuropathy, or brain metastasis.

What is being tested?

The study compares the efficacy and safety of two treatments: Serplulimab plus chemotherapy (carboplatin-etoposide) versus Atezolizumab plus the same chemotherapy in untreated ES-SCLC patients. Participants will be randomly assigned to either Arm A (Serplulimab group) or Arm B (Atezolizumab control group).

What are the potential side effects?

Potential side effects include reactions related to infusion of drugs like fatigue, digestive issues such as nausea and vomiting; blood disorders that can affect immunity; liver problems; kidney function changes; nerve damage symptoms like numbness; and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I have been newly diagnosed with extensive-stage small cell lung cancer.

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I can move around freely despite my symptoms.

Exclusion Criteria

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

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I have received treatment for my small cell lung cancer.

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You have been diagnosed with HIV, Hepatitis B, or Hepatitis C.

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I have not had any other cancers in the last 5 years.

100% of travel, accommodation, and treatment cost is covered.The company running this study will pay for:

Chemotherapy medication & the investigational drug or Atezolizumab (standard of care) depending on which group a patient is assigned to.

Travel, accommodation, and meals required to support your participation in the trial.

Serplulimab Efficacy

Patients demonstrated better survival rates when receiving Serplulimab than chemotherapy alone.

Serplulimab + Chemo

Chemo alone

Overall Survival %

Duration of survival, month

Serplulimab Efficacy

Serplulimab led to >5x improvement in two year overall survival.

2-Year Overall Survival %

Timeline

Screening ~ 28 days1 visit

Treatment ~ 5 months1 visit

Follow Up ~ 60 months1 visit

Screening ~ 28 days

Treatment ~ 5 months

Follow Up ~60 months

This trial's timeline: 28 days for screening, 5 months for treatment, and 60 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

Secondary study objectives

Average Plasma Concentration (Cavg)

Maximum Plasma Concentration (Cmax)

Minimum Plasma Concentration (Cmin)

+3 more

Awards & Highlights

Verified Trial Data

This sponsor has confirmed the contact details & information for their site to make enrollment simpler.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Serplulimab + chemotherapyExperimental Treatment1 Intervention

Serplulimab + chemotherapy (carboplatin-etoposide)

Group II: Atezolizumab + chemotherapyActive Control1 Intervention

Atezolizumab + chemotherapy (carboplatin-etoposide)

0 / 5Eligibility 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 and immunotherapy. Chemotherapy agents like carboplatin and etoposide work by damaging the DNA of cancer cells, inhibiting their ability to divide and proliferate. Immunotherapy, particularly PD-1 inhibitors such as Serplulimab, enhances the immune system's response against cancer by blocking the interaction between the PD-1 protein on T-cells and PD-L1 on cancer cells. This blockade prevents the cancer cells from evading immune detection, allowing the immune system to target and destroy them more effectively. These mechanisms are crucial for SCLC patients due to the aggressive nature of the disease, offering a means to control its rapid progression and potentially improve survival outcomes.

Aerosolized granulocyte macrophage colony-stimulating factor (GM-CSF) therapy in metastatic cancer.