What side effects are associated with this type of intervention?

Treatments for Small Cell Lung Cancer (SCLC) involving immune checkpoint inhibitors like Pembrolizumab (a PD-1 inhibitor) and similar agents can cause a range of immune-related side effects. Common side effects include inflammation in various organs, such as pneumonitis (lung inflammation), colitis (colon inflammation), hepatitis (liver inflammation), endocrinopathies (hormonal gland issues), and skin reactions. Severe side effects, though less common, can occur and may require withholding the drug and administering immunosuppressive treatments.

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. Nivolumab, a PD-1 inhibitor, has also been approved for the treatment of SCLC, particularly in the relapsed setting. These approvals highlight the role of immunotherapy in enhancing the immune system's ability to detect and fight cancer cells in SCLC.

What other types of research exist?

A promising alternative to Pembrolizumab/Vibostolimab for Small Cell Lung Cancer patients is Atezolizumab in combination with etoposide and platinum-based chemotherapy. This combination has been evaluated in clinical trials and may offer a viable treatment option.

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Checkpoint Inhibitor

Immunotherapy + Chemotherapy for Small Cell Lung Cancer

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

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

Must have

Has histologically or cytologically confirmed diagnosis of ES-SCLC in need of first-line therapy

Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan

Must not have

Has a known history of, or active, neurologic paraneoplastic syndrome

Has had an allogenic tissue/solid organ transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 60 months

Awards & highlights

Pivotal Trial

Summary

This trial tests a new combination of immunotherapy and chemotherapy for patients with advanced lung cancer. The treatment uses two drugs to help the immune system fight cancer, along with standard chemotherapy to kill cancer cells. Researchers hope this new approach will improve survival compared to existing treatments.

Who is the study for?

This trial is for adults with a confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) who need first-line therapy. Participants must have a life expectancy over 3 months, agree to contraception if applicable, and not be pregnant or breastfeeding. Exclusions include severe allergies to study drugs, recent major surgery, active infections, certain medical conditions like CNS metastases or HIV, prior SCLC treatment, and recent live vaccines.

What is being tested?

The trial tests pembrolizumab/vibostolimab co-formulation with etoposide/platinum chemotherapy against atezolizumab with the same chemo in treating ES-SCLC. The goal is to see if the new drug combo improves overall survival compared to the existing treatment option.

What are the potential side effects?

Potential side effects may include allergic reactions to medication components, immune-related issues affecting organs due to pembrolizumab/vibostolimab or atezolizumab; fatigue; blood disorders; increased risk of infection from chemotherapy agents like cisplatin and carboplatin.

Eligibility Criteria

Inclusion Criteria

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

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I have small cell lung cancer and need first-line therapy.

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My small cell lung cancer is at stage IV or has spread extensively within my lungs.

Exclusion Criteria

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

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I have a history of or currently have a neurological disorder related to cancer.

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I have received an organ or tissue transplant from another person.

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I have another cancer that is getting worse or was treated in the last 3 years.

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I have received treatment for Small Cell Lung Cancer.

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I have fluid buildup in my abdomen or around my lungs.

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I have cancer that has spread to my brain or spinal cord.

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I am currently being treated for an infection.

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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

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I have or had lung inflammation that needed steroids.

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I will not need any cancer treatment other than the study for my small cell lung cancer.

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I have a history of Hepatitis B or active Hepatitis C.

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I have been treated for an autoimmune disease in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 60 months

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

Overall Survival (OS)

Secondary study objectives

Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13

Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)

Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30

+12 more

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab/VibostolimabExperimental Treatment5 Interventions

Participants will receive 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W), in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve (AUC) 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of MK-7684A Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.

Group II: AtezolizumabActive Control5 Interventions

Participants will receive 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of atezolizumab Q3W until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Saline placebo

2005

Completed Phase 4

~22080

Etoposide

2010

Completed Phase 3

~2960

Carboplatin

2014

Completed Phase 3

~6120

0 / 14Eligibility 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 immune checkpoint inhibitors. Chemotherapy, often using etoposide and platinum-based drugs, works by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Immune checkpoint inhibitors, such as Pembrolizumab (a PD-1 inhibitor) and Vibostolimab (a TIGIT inhibitor), enhance the immune system's ability to detect and destroy cancer cells. Pembrolizumab blocks the PD-1 pathway, preventing cancer cells from evading immune detection, while Vibostolimab inhibits TIGIT, further modulating the immune response to enhance anti-tumor activity. These treatments are crucial for SCLC patients as they offer a way to target the cancer more precisely and potentially improve survival rates.

Novel algorithmic approach predicts tumor mutation load and correlates with immunotherapy clinical outcomes using a defined gene mutation set.