What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include PD-1 inhibitors like Cemiplimab, often combined with chemotherapy. Known side effects of PD-1 inhibitors include fatigue, rash, diarrhea, and more severe immune-related adverse events such as pneumonitis, colitis, hepatitis, and endocrinopathies. Chemotherapy side effects typically include nausea, vomiting, hair loss, anemia, increased risk of infection, and neuropathy. Combining these treatments can lead to a higher incidence of severe side effects, including grade 3 or 4 toxicities such as severe fatigue, neutropenia, and organ-specific toxicities.

What prior FDA approvals exist?

Cemiplimab, a PD-1 inhibitor, has been FDA-approved for the treatment of advanced NSCLC with PD-L1 expression of ≥50% without EGFR, ROS1, or ALK genetic aberrations. Other similar FDA-approved treatments include pembrolizumab, another PD-1 inhibitor, which is approved for use in combination with chemotherapy for advanced NSCLC. Atezolizumab, a PD-L1 inhibitor, has also been approved in combination with chemotherapy and bevacizumab for advanced non-squamous NSCLC. These approvals highlight the growing role of immunotherapy, particularly PD-1 and PD-L1 inhibitors, in the treatment of advanced NSCLC.

What other types of research exist?

Promising alternatives to BNT116 and cemiplimab for NSCLC patients include: 1) Pembrolizumab plus chemotherapy, which has shown improved OS and PFS in both nonsquamous and squamous NSCLC. 2) Durvalumab plus chemotherapy, which has shown improved PFS in metastatic NSCLC. 3) Furmonertinib, a potential treatment for EGFR mutation-positive NSCLC with an acceptable safety profile.

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PD-1/PD-L1 Inhibitor

Cemiplimab + BNT116 for Non-Small Cell Lung Cancer

Phase 2

Recruiting

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is researching 2 drugs to treat advanced non-small cell lung cancer to see how effective and safe they are.

Who is the study for?

Adults with advanced non-small cell lung cancer (NSCLC) who have not had prior treatments for metastatic disease, and whose tumors show high levels of PD-L1 protein. Participants should be in relatively good physical condition (ECOG ≤1), able to provide a tumor tissue sample, and not have other serious health issues or infections like HIV or hepatitis.Check my eligibility

What is being tested?

The trial is testing the safety and effectiveness of BNT116 in combination with cemiplimab versus using cemiplimab alone. It aims to understand how well these drugs work together to treat NSCLC, what side effects may occur, drug levels in blood over time, and if the body develops antibodies against them.See study design

What are the potential side effects?

Potential side effects from receiving BNT116 combined with cemiplimab might include immune system reactions that could affect various organs, allergic responses to the infusion process itself, fatigue, changes in blood chemistry values indicating organ function alterations or infection risk.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate (ORR) as assessed by blinded independent review committee (BIRC) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

Secondary outcome measures

DOR by investigator assessment

Duration of Response (DOR) as assessed by BIRC using RECIST 1.1

Incidence of treatment-emergent adverse events (TEAEs)

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2: CemiplimabExperimental Treatment1 Intervention

Arm A: Cemiplimab is administered by IV infusion Q3W

Group II: Phase 2: BNT116 + CemiplimabExperimental Treatment2 Interventions

Arm B: BNT116 is administered by IV injection. Cemiplimab is administered by IV infusion Q3W.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1340

Do I qualify?Apply below to find out

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

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapies and targeted therapies. BNT116, an investigational cancer vaccine, aims to stimulate the immune system to recognize and attack cancer cells. Cemiplimab, a PD-1 inhibitor, blocks the PD-1 protein on immune cells, preventing cancer cells from evading immune detection. These mechanisms are significant for NSCLC patients as they leverage the body's immune system to combat cancer, potentially improving outcomes and reducing side effects compared to conventional chemotherapy.

Large Cell Neuro-Endocrine Carcinoma of the Lung: Current Treatment Options and Potential Future Opportunities.Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial.Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial.

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

629 Previous Clinical Trials

381,905 Total Patients Enrolled

BioNTech SEIndustry Sponsor

66 Previous Clinical Trials

108,133 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

266 Previous Clinical Trials

252,212 Total Patients Enrolled

Media Library

BNT116 (PD-1/PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05557591 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Phase 2: Cemiplimab, Phase 2: BNT116 + Cemiplimab

Non-Small Cell Lung Cancer Clinical Trial 2023: BNT116 Highlights & Side Effects. Trial Name: NCT05557591 — Phase 2

BNT116 (PD-1/PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05557591 — Phase 2

~67 spots leftby Mar 2027

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