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BNT116 + Cemiplimab vs Cemiplimab in First-Line Advanced NSCLC
NCT05557591Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Apr 2023
- Primary completion
- Jan 2028
- Countries
- 7
- Sponsor
- Regeneron Pharmaceuticals
- Modality
- Therapeutic Vaccines, mRNA Therapeutics
- Drugs
- BNT116
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 2, randomised trial of BNT116 in non-small cell lung cancer (NSCLC) (2 arms), sponsored by Regeneron Pharmaceuticals. Primary endpoint: Objective Response Rate by BIRC at 136 weeks. Started Apr 2023; status: active, not recruiting.
02
Design
2 arms- Study design
- Randomized
Phase 2: Cemiplimab
Cemiplimab is administered by IV infusion Q3W
Phase 2: BNT116 + Cemiplimab
BNT116 is administered by IV injection. Cemiplimab is administered by IV infusion Q3W.
03
Who it enrols
Patients with stage IIIB/IIIC or IV NSCLC, PD-L1 ≥50%, ECOG ≤1, no prior systemic therapy for metastatic disease, and no EGFR, ALK, or ROS1 mutations. Must have a smoking history.
04
Endpoints
Primary
Objective Response Rate by BIRC
Secondary
Objective Response Rate by Investigator
Duration of Response by BIRC
Duration of Response by Investigator
Progression-Free Survival by BIRC
Progression-Free Survival by Investigator
Overall Survival
Incidence of Treatment-Emergent Adverse Events
Incidences of Serious Adverse Events
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