Active Not Recruiting PHASE2 INTERVENTIONAL 2-arm NCT05557591

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)

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%

Sponsor: BioNTech SE

Conditions Advanced Non-Small Cell Lung Cancer

Interventions BNT116 Cemiplimab

Updated 21 times since 2022 Last updated: Aug 20, 2025 Started: Apr 21, 2023 Primary completion: Jan 26, 2028 Completion: May 16, 2028

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Advanced Non-Small Cell Lung Cancer, this trial is ongoing. The trial is conducted by BioNTech SE and has accumulated 21 data snapshots since 2023. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

21 versions recorded

Sep 2025 — Present [monthly]

Active Not Recruiting PHASE2

Status: Recruiting → Active Not Recruiting
Aug 2025 — Sep 2025 [monthly]

Recruiting PHASE2
Jul 2025 — Aug 2025 [monthly]

Recruiting PHASE2
Jun 2025 — Jul 2025 [monthly]

Recruiting PHASE2
May 2025 — Jun 2025 [monthly]

Recruiting PHASE2

▶ Show 16 earlier versions

Apr 2025 — May 2025 [monthly]

Recruiting PHASE2
Mar 2025 — Apr 2025 [monthly]

Recruiting PHASE2
Dec 2024 — Mar 2025 [monthly]

Recruiting PHASE2
Oct 2024 — Dec 2024 [monthly]

Recruiting PHASE2
Sep 2024 — Oct 2024 [monthly]

Recruiting PHASE2
Jul 2024 — Sep 2024 [monthly]

Recruiting PHASE2
Jun 2024 — Jul 2024 [monthly]

Recruiting PHASE2
May 2024 — Jun 2024 [monthly]

Recruiting PHASE2
Mar 2024 — May 2024 [monthly]

Recruiting PHASE2
Nov 2023 — Mar 2024 [monthly]

Recruiting PHASE2
Sep 2023 — Nov 2023 [monthly]

Recruiting PHASE2
Aug 2023 — Sep 2023 [monthly]

Recruiting PHASE2
Jul 2023 — Aug 2023 [monthly]

Recruiting PHASE2

Status: Not Yet Recruiting → Recruiting · Phase: PHASE1_PHASE2 → PHASE2
Apr 2023 — Jul 2023 [monthly]

Not Yet Recruiting PHASE1_PHASE2
Feb 2023 — Apr 2023 [monthly]

Not Yet Recruiting PHASE1_PHASE2
Sep 2022 — Feb 2023 [monthly]

Not Yet Recruiting PHASE1_PHASE2

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

BioNTech SE
Regeneron Pharmaceuticals

Data source: Regeneron Pharmaceuticals

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Adana, Turkey (Türkiye) , Ankara, Turkey (Türkiye) , Badalona, Spain , Batumi, Georgia , Bornova, Turkey (Türkiye) , Castellon, Spain , Fairfax, United States , Farmington, United States , Frankfurt, Germany , Giessen, Germany and 26 more locations