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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

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

622 Previous Clinical Trials

380,631 Total Patients Enrolled

BioNTech SEIndustry Sponsor

64 Previous Clinical Trials

107,598 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

263 Previous Clinical Trials

251,314 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many institutions are managing this experiment?

"4 different medical centres are now enrolling patients for this trial. These include Charlotte, Pinehurst, and Houston with one more undisclosed site. To minimize travel time and costs it is beneficial to select the closest centre available."

Answered by AI

Can you tell me the upper limit of participants in this experiment?

"Affirmative. According to data listed on clinicaltrials.gov, this medical investigation is currently recruiting patients after being first posted on April 21st 2023 and subsequently updated at the end of May 2023. One hundred individuals must be recruited from 4 distinct sites."

Answered by AI

What is the end goal of this research endeavor?

"This medical trial will be monitored for up to 136 weeks, and its primary objective is to evaluate the prevalence of adverse events. Secondary objectives encompass progression-free survival (PFS), incidences of laboratory abnormalities (>Grade 3 CTCAE v5.0 causality grading system) as well as duration of response (DOR) by investigator assessment."

Answered by AI

Are any new participants being accepted for the clinical trial at this time?

"Affirmative. The clinical trial's registration information on clinicaltrials.gov indicates that it is actively recruiting patients, which began in April 2021 and was most recently updated in May of this year. A total of 100 volunteers are needed to be recruited from 4 different sites."

Answered by AI

What potential health risks have been associated with Phase 1: BNT116 + Cemiplimab?

"Due to the fact that this is still a Phase 2 trial, and there is only provisional data indicating safety but no efficacy evidence yet, our team at Power has rated BNT116 + Cemiplimab with a score of 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Intravenous Cemiplimab Plus BNT116 Versus Cemiplimab Alone in Advanced Non-Small Cell Lung Cancer in Adult Participants With PD-L1 ≥ 50%

2023. "Safety and Efficacy of Intravenous Cemiplimab Plus BNT116 Versus Cemiplimab Alone in Advanced Non-Small Cell Lung Cancer in Adult Participants With PD-L1 ≥ 50%". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05557591.

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