A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1)

Phase 2

Active, not recruiting

• Conditions: Advanced Non-Small Cell Lung Cancer
• Interventions: Drug: BNT116; Drug: Cemiplimab

• Registration Number: NCT05557591
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

This study is researching an investigational drug, called BNT116, in combination with cemiplimab. BNT116 and cemiplimab will each be called a "study drug", and together be called "study drugs". The study is focused on patients who have advanced non-small cell lung cancer (NSCLC).

The aims of this study are to see how safe and tolerable BNT116 is in combination with cemiplimab and to see how effective BNT116 in combination with cemiplimab is compared to cemiplimab by itself at treating cancer.

The study is looking at several other research questions, including:

* What side effects may happen from receiving the study drugs

* How much study drug is in the blood at different times

* Whether the body makes antibodies against the study drug(s) (which could make the drug less effective or could lead to side effects)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-28
• Study Start: 2023-04-21
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-20
• Last Update Posted: 2025-08-21
• Primary Completion: 2028-01-26
• Study Completion: 2028-05-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 2: BNT116 + Cemiplimab	BNT116	Arm B: BNT116 is administered by IV injection. Cemiplimab is administered by IV infusion Q3W.
Phase 2: Cemiplimab	Cemiplimab	Arm A: Cemiplimab is administered by IV infusion Q3W
Phase 2: BNT116 + Cemiplimab	Cemiplimab	Arm B: BNT116 is administered by IV injection. Cemiplimab is administered by IV infusion Q3W.

Primary Outcome Measures

Name	Time	Method
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)	Up to 136 weeks from randomization	Proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR)

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DOR) as assessed by BIRC using RECIST 1.1	Up to 3 years from last patient randomized	The time from first response of CR or PR to first radiographic progression or death due to any cause for patients with confirmed CR or PR
DOR by investigator assessment	Up to 3 years from last patient randomized	The time from first response of CR or PR to first radiographic progression or death due to any cause for patients with confirmed CR or PR
Progression Free Survival (PFS) as assessed by BIRC using RECIST 1.1	Up to 3 years from last patient randomized	The time from randomization to the date of the first radiographic progression or death due to any cause, whichever occurred earlier
ORR by investigator assessment	Up to 136 weeks from randomization	Proportion of patients with a best overall response of confirmed CR or PR
Incidence of treatment-emergent adverse events (TEAEs)	Up to 3 years	A TEAE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
PFS by investigator assessment	Up to 3 years from last patient randomized	The time from randomization to the date of the first radiographic progression or death due to any cause, whichever occurred earlier
Overall Survival (OS)	Up to 3 years from last patient randomized	The time from enrollment to the date of death due to any cause
Incidences of serious adverse events (SAEs)	Up to 3 years	An SAE is any untoward medical occurrence that at any dose: * Results in death - includes all deaths, even those that appear to be completely unrelated to study drug (eg, a car accident in which a patient is a passenger); * Is life-threatening; * Requires in-patient hospitalization or prolongation of existing hospitalization; * Results in persistent or significant disability/incapacity; * Is a congenital anomaly/birth defect; * Is an important medical event
Incidences of deaths	Up to 3 years
Incidences of laboratory abnormalities	Up to 3 years	According to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Causality grading system (≥ Grade 3 or higher)

Trial Locations

Locations (52)

Northwest Medical Specialties, PLLC; 🇺🇸 Tacoma, Washington, United States

LTD High Technology Hospital Medcenter; 🇬🇪 Batumi, Georgia

LLC Todua Clinic; 🇬🇪 Tbilisi, Georgia

LTD New Hospitals; 🇬🇪 Tbilisi, Georgia

LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic; 🇬🇪 Tbilisi, Georgia

LTD Cancer Research Centre; 🇬🇪 Tbilisi, Georgia

Caucasus Medical Centre; 🇬🇪 Tbilisi, Georgia

Staedtisches Klinikum Muenchen Bogenhausen; 🇩🇪 Munchen, Bavaria, Germany

Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt; 🇩🇪 Frankfurt, Germany

Universitaetsklinikum Giessen Und Marburg Gmbh Standort Giessen; 🇩🇪 Giessen, Germany

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