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Joint Clinical Trials Office

A Phase 2 Study of Cemiplimab (Anti-PD-1 Antibody) in Combination with BNT116 (FixVac Lung) versus Cemiplimab Monotherapy in First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with Tumors Expressing PD-L1 ≥50%

Clinical Trial Details

The purpose of the study is to collect more information on the safety of BNT116 in combination with cemiplimab and to see how well combining the study drugs work in treating advanced non-small cell lung cancer (NSCLC).
   
The study is researching an investigational drug, called BNT116, in combination with cemiplimab. Investigational means that it has not yet been approved by the U.S. Food and Drug Administration (FDA) alone or in combination with other drugs.
   
The aims of the 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.

All participants will receive the same doses of the medications. BNT116 is administered via intravenous (IV) injection and cemiplimab is administered via IV infusion. If BNT116 is not well tolerated, the dose can be reduced. The study doctor will let each participant know the dose they are receiving at any time. 

Total study participation will last about 33 months.

Key Eligibility: 
  1. Participants with non-squamous or squamous histology non-small cell lung cancer (NSCLC) with stage IIIB or stage IIIC disease who are not candidates for surgical resection or definitive chemoradiation per investigator assessment or stage IV (metastatic) disease who received no prior systemic treatment for recurrent or metastatic NSCLC   
  2. Expression of Programmed cell death ligand-1 (PD-L1) in more than 50% of tumor cells   

Detailed eligibility will be discussed when reaching out to the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

June Greenberg, RN
(212) 746-2651
jdg2002@med.cornell.edu

Primary Investigator(s)

Ashish Saxena, MD, PhD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2311026732

ClinicalTrials.gov:

NCT05557591

Sponsor:

R2810-ONC-2045

Status

Open to Enrollment

Age Group

Adult

Sponsor

  • Regeneron

Disease

Lung Cancer
Non-Small Cell Lung Cancer