What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy agents like Cisplatin, Carboplatin, and Etoposide, as well as immunotherapy agents like Nivolumab. Chemotherapy drugs can cause side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infection due to lowered white blood cell counts. Nivolumab, an immunotherapy agent, can lead to immune-related adverse effects including inflammation of organs such as the lungs (pneumonitis), liver (hepatitis), and intestines (colitis), as well as skin rashes and endocrine disorders. These side effects occur because the immune system may attack normal tissues in addition to cancer cells.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of various cancers, including nivolumab, which is being studied for its efficacy in treating extensive stage Small Cell Lung Cancer (SCLC). Nivolumab is a monoclonal antibody that helps the immune system attack cancer cells and interferes with tumor growth and spread. Other similar FDA-approved drugs include pembrolizumab, which targets the PD-1/PD-L1 pathway and has shown benefits in treating cancers like non-small cell lung cancer (NSCLC) and metastatic melanoma. These treatments represent a significant advancement in cancer therapy by leveraging the body's immune system to combat tumor cells.

What other types of research exist?

Promising novel alternatives to Nivolumab for Small Cell Lung Cancer patients include Pembrolizumab, which has shown efficacy in NSCLC and may be considered for SCLC, and Atezolizumab, which has demonstrated safety and efficacy in advanced NSCLC patients with or without baseline brain metastases. Additionally, combination therapies involving checkpoint inhibitors and chemotherapy, such as those studied in the IMpower 150 trial, may offer new treatment avenues.

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Platinum-based Chemotherapy

Chemotherapy + Nivolumab for Small Cell Lung Cancer

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

The most common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy and immunotherapy. Chemotherapy agents like cisplatin, carboplatin, and etoposide work by killing cancer cells, inhibiting their division, and preventing their spread. Immunotherapy, such as Nivolumab, employs monoclonal antibodies to enhance the immune system's ability to recognize and attack cancer cells, while also interfering with tumor cell growth and spread. This multi-faceted approach is crucial for SCLC patients as it targets the cancer through different mechanisms, potentially leading to better treatment outcomes and improved survival rates.

Phase 2

Waitlist Available

Led By Ticiana A Leal

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

No patients with specific autoimmune diseases, neuromuscular paraneoplastic syndromes, or conditions requiring systemic treatment with corticosteroids or immunosuppressive medications

No patients with symptomatic interstitial lung disease or severe hypersensitivity reaction to study drug components

Must not have

Patients are ineligible if they received a live, attenuated vaccine within 4 weeks before randomization

Patients must NOT have uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until being off treatment or end of observation. thereafter every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding nivolumab to standard chemotherapy improves treatment for patients with extensive stage small cell lung cancer. The chemotherapy drugs kill or stop the growth of cancer cells, while nivolumab helps the immune system attack the cancer. Nivolumab is an immunotherapy drug that has shown promise in treating various cancers, including non-small cell lung cancer and melanoma.

Who is the study for?

This trial is for adults with extensive stage small cell lung cancer who haven't had prior treatment. They must have normal organ and marrow function, no severe allergies to monoclonal antibodies or study drugs, and not be on other investigational agents. Women of childbearing age and sexually active men must use contraception.

What is being tested?

The trial tests if adding Nivolumab (an immunotherapy drug) to standard chemotherapy (Cisplatin/Carboplatin and Etoposide) improves outcomes in patients with extensive stage small cell lung cancer compared to chemotherapy alone.

What are the potential side effects?

Possible side effects include allergic reactions, immune system-related issues affecting organs, fatigue, nausea, low blood counts increasing infection risk. Nivolumab may also cause skin problems or hormonal gland changes.

Eligibility Criteria

Inclusion Criteria

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

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I do not have autoimmune diseases or conditions needing steroids or immunosuppressants.

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I do not have lung disease causing symptoms or severe allergies to the study drug.

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My blood tests and liver/kidney function are within required ranges.

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I have no severe allergies to monoclonal antibodies or the study drug's components.

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I have extensive stage small cell lung cancer and can undergo systemic therapy.

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I have not received chemotherapy or biologic therapy for my extensive stage small cell lung cancer.

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I haven't received drugs targeting my immune system to treat cancer.

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I do not have lung disease that causes symptoms or could affect lung toxicity tests.

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I am fully active or can carry out light work.

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I have been cancer-free for at least 2 years if I had another cancer.

Exclusion Criteria

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

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

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I do not have cancer that has spread to the lining of my brain and spinal cord.

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I am not HIV-positive or not on combination antiretroviral therapy.

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I am not pregnant or breast-feeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until being off treatment or end of observation. thereafter every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until being off treatment or end of observation. thereafter every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until being off treatment or end of observation. thereafter every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 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

Progression-free Survival (PFS)

Secondary study objectives

Overall Survival (OS)

Response Rate

Awards & Highlights

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: Arm A (nivolumab, CE)Experimental Treatment4 Interventions

Patients receive nivolumab IV over 30 minutes on day 1, carboplatin IV over 30-60 minutes on day 1 or cisplatin IV over 60-120 minutes on day 1, and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive nivolumab IV over 30 minutes every 2 weeks for up to 2 years.

Group II: Arm B (CE)Active Control3 Interventions

Patients receive carboplatin IV over 30-60 minutes on day 1 or cisplatin IV over 60-120 minutes on day 1, and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Cisplatin

2013

Completed Phase 3

~3120

Etoposide

2010

Completed Phase 3

~2960

Nivolumab

2015

Completed Phase 3

~4010

0 / 15Eligibility 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 cisplatin, carboplatin, and etoposide work by killing cancer cells, inhibiting their division, and preventing their spread. Immunotherapy, such as Nivolumab, employs monoclonal antibodies to enhance the immune system's ability to recognize and attack cancer cells, while also interfering with tumor cell growth and spread. This multi-faceted approach is crucial for SCLC patients as it targets the cancer through different mechanisms, potentially leading to better treatment outcomes and improved survival rates.

Cancer Vaccines and Oncolytic Viruses Exert Profoundly Lower Side Effects in Cancer Patients than Other Systemic Therapies: A Comparative Analysis.Nivolumab for the treatment of small cell lung cancer.Focus on Nivolumab in NSCLC.