What side effects are associated with this type of intervention?

The most common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy agents such as etoposide and platinum-based drugs (carboplatin or cisplatin), often combined with immune checkpoint inhibitors like atezolizumab. Known side effects of these treatments include nausea, vomiting, hair loss, fatigue, increased risk of infection due to low white blood cell counts, and neuropathy. Immune checkpoint inhibitors can also cause immune-related side effects such as rash, diarrhea, and inflammation of organs like the lungs (pneumonitis) and liver (hepatitis).

What prior FDA approvals exist?

The FDA has approved several treatments for Small Cell Lung Cancer (SCLC), including chemotherapy regimens such as etoposide combined with either cisplatin or carboplatin. Additionally, immune checkpoint inhibitors like atezolizumab have been approved for use in combination with chemotherapy for extensive-stage SCLC. While BNT411, a TLR7 agonist, is still under investigation, it is expected to enhance immune responses when combined with cytotoxic therapies and immune checkpoint inhibitors, similar to the approved use of atezolizumab with chemotherapy.

What other types of research exist?

Promising novel alternatives to BNT411 for Small Cell Lung Cancer patients include TNO155, an allosteric SHP2 inhibitor that blocks receptor tyrosine kinase signaling, and immune checkpoint inhibitors like pembrolizumab and nivolumab, which have shown efficacy in various cancers including lung cancer. Additionally, combination therapies involving these agents may offer enhanced therapeutic benefits.

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Checkpoint Inhibitor

BNT411 + Chemotherapy for Small Cell Lung Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by BioNTech SE

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system) who received no prior chemotherapy for extensive stage disease.

For Part 1A: Histologically confirmed solid tumor that is metastatic or unresectable with no available standard therapy likely to confer clinical benefit, or patients who are not candidates for such available therapy

Must not have

Has any contraindication to atezolizumab, carboplatin or etoposide as per US prescribing information (USPI) or summary of product characteristics (SmPC) in Part 1B

Known history/positive serology for hepatitis B requiring active anti-viral therapy, active Hepatitis C virus (HCV) infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called BNT411, which helps the immune system fight cancer. It is being tested on patients with advanced cancers, including a specific type of lung cancer. BNT411 works by boosting the immune system's ability to attack cancer cells, especially when combined with other treatments.

Who is the study for?

This trial is for adults with ES-SCLC who haven't had chemo for it yet, or those with solid tumors without standard treatment options. Participants must be over 18, have a certain level of physical fitness (ECOG 0-1), and not have specific health issues like interstitial lung disease. They should also agree to use birth control if necessary and provide tissue samples.

What is being tested?

The trial tests BNT411 alone and combined with Atezolizumab, Carboplatin, and Etoposide in cancer patients. It's the first time this drug—a TLR7 agonist expected to boost immune responses—is being used in humans to find a safe dosage.

What are the potential side effects?

Potential side effects include typical reactions from immune therapies such as inflammation in various organs, infusion-related symptoms, fatigue, digestive problems, blood disorders, increased risk of infections and possibly others related to the novel nature of BNT411.

Eligibility Criteria

Inclusion Criteria

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

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My small cell lung cancer is in the extensive stage and I haven't had chemotherapy for it.

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My cancer has spread, can't be surgically removed, and I can't be treated with standard therapies.

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I do not have lung diseases like interstitial lung disease or pneumonitis.

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My cancer is advanced, cannot be surgically removed, and has no standard treatment options.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I am not allergic or unable to take atezolizumab, carboplatin, or etoposide.

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I am currently being treated for hepatitis B or have an active hepatitis C infection.

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I have another cancer that has not been in remission for 2 years.

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I am HIV positive with low CD4+ counts and have had AIDS-related infections.

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I have been treated with a TLR7 agonist before.

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I am taking more than 10 mg of prednisone or its equivalent daily for another health issue.

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I am not taking strong drugs that affect liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1 and 2: Incidence of IMP treatment discontinuations due to toxicity

Part 1 and 2: Incidence of TEAEs

Part 1 and 2: Incidence of dose-limiting toxicities (DLTs)

+3 more

Secondary study objectives

Part 2 only: Disease Control Rate (DCR)

Part 2 only: Duration of Response (DOR)

Part 2 only: Objective Response Rate (ORR)

Other study objectives

Part 2 only: Overall Survival (OS) time

Part 2 only: Progression Free Survival (PFS) time

Part 2 only: immune Disease Control Rate (iDCR)

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 2 - expansion cohortsExperimental Treatment4 Interventions

BNT411 either as monotherapy or in combination with with atezolizumab, carboplatin, and etoposide

Group II: Part 1B - combination dose escalationExperimental Treatment4 Interventions

BNT411 in combination with atezolizumab, carboplatin, and etoposide

Group III: Part 1A - monotherapy dose escalationExperimental Treatment1 Intervention

BNT411 monotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Etoposide

2010

Completed Phase 3

~2960

Carboplatin

2014

Completed Phase 3

~6120

0 / 12Eligibility 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, immune checkpoint inhibitors, and emerging therapies like the TLR7 agonist BNT411. Chemotherapy agents such as etoposide and carboplatin/cisplatin work by causing DNA damage in cancer cells, leading to their death. Immune checkpoint inhibitors, like anti-PD-1 or anti-PD-L1 therapies, boost the immune system's ability to attack cancer cells by blocking proteins that suppress immune responses. The TLR7 agonist BNT411 aims to activate both innate and adaptive immune responses, potentially enhancing the efficacy of other treatments. These mechanisms are vital for SCLC patients as they address the cancer's aggressive behavior through multiple pathways, potentially improving treatment effectiveness and patient outcomes.

Innovative Treatment Concepts for Cutaneous T-Cell Lymphoma Based on Microenvironment Modulation.