What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, radiotherapy, and PD-1 inhibitors. Chemotherapy, such as etoposide with cisplatin or carboplatin, often causes nausea, vomiting, hair loss, fatigue, and increased infection risk. Radiotherapy can result in esophagitis, pneumonitis, and fatigue. PD-1 inhibitors, like Serplulimab, may lead to immune-related side effects including skin reactions, endocrine disorders, and pneumonitis, with potential for severe immune-mediated reactions and organ-specific toxicities.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of Small Cell Lung Cancer (SCLC). Atezolizumab, a PD-L1 inhibitor, was approved in combination with carboplatin and etoposide for first-line treatment of extensive-stage SCLC. Similarly, Durvalumab, another PD-L1 inhibitor, has been approved for use with platinum-etoposide chemotherapy in the first-line setting for extensive-stage SCLC. These approvals are based on clinical trials demonstrating improved survival outcomes when these immunotherapies are added to standard chemotherapy regimens. Serplulimab, a PD-1 inhibitor, is being studied in a similar context, combining with chemotherapy and radiotherapy for limited-stage SCLC.

What other types of research exist?

Promising alternatives to Serplulimab for SCLC patients include Pembrolizumab and Nivolumab, both of which are PD-1 inhibitors. Additionally, Atezolizumab, a PD-L1 inhibitor, has shown efficacy in combination with chemotherapy. Emerging therapies and combination treatments involving these inhibitors are also being actively researched and may offer new options in 2024.

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Monoclonal Antibodies

Serplulimab + Chemotherapy for Small Cell Lung Cancer

Verified Trial

Phase 3

Recruiting

Led By Jinming Yu, MD

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 limited-stage small cell lung cancer

You are completely mobile even with current symptoms

Must not have

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

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

Timeline

Screening 28 days

Treatment 12 months

Follow Up 60 months

Awards & highlights

Pivotal Trial

Verified Trial Data

Summary

This trial tests if adding a new drug called Serplulimab to standard treatments (chemotherapy and radiotherapy) can help patients with a specific type of lung cancer. Serplulimab aims to boost the immune system to fight cancer more effectively. Serplulimab has shown benefits when combined with chemotherapy in previous trials.

Who is the study for?

This trial is for adults newly diagnosed with limited-stage small cell lung cancer who haven't had any treatment yet. They should be able to carry out daily activities, not have HIV or hepatitis, and no other cancers in the last 5 years except certain cured skin or localized cancers.

What is being tested?

The study tests if Serplulimab combined with chemotherapy and radiotherapy works better than just chemo and radiotherapy for this type of lung cancer. It's a phase III trial where patients are randomly assigned to either the drug or a placebo without knowing which one they get.

What are the potential side effects?

Possible side effects include reactions related to immune system activation by Serplulimab, such as inflammation in various organs, fatigue, nausea from chemotherapy, and skin irritation from radiotherapy.

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 early-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 tested positive for HIV, Hepatitis B, or Hepatitis C.

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I have undergone treatment for small cell lung cancer.

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My small cell lung cancer has spread to other parts of my body.

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I have had another type of cancer besides small cell lung cancer 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 days2 visits

Treatment ~ 12 months18 visits

Follow Up ~ 60 months2 visits

Screening ~ 28 days

Treatment ~ 12 months

Follow Up ~60 months

This trial's timeline: 28 days for screening, 12 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

To assess the overall survival of patients

Secondary study objectives

To assess how long patients respond to the drug without their tumor growing in size

To assess the change in tumor size

Awards & Highlights

Pivotal Trial

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

Verified Trial Data

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Serplulimab + carboplatin/cisplatin-etoposide + radiotherapyExperimental Treatment4 Interventions

Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus Serplulimab 300 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.

Group II: placebo + carboplatin/cisplatin-etoposide + radiotherapyPlacebo Group4 Interventions

Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus placebo every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Thoracic radiotherapy

2018

Completed Phase 2

~70

0 / 6Eligibility 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 and cisplatin 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, particularly PD-1 inhibitors such as Serplulimab, blocks the PD-1 protein on T-cells, reactivating them to recognize and destroy cancer cells. These treatments are vital for SCLC patients as they target the rapid proliferation and spread of cancer cells, thereby improving survival rates and quality of life.

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