FYB206

BIOLOGICAL3 trials

Sponsors

Formycon AG

Conditions

Melanoma Stage IIIMelanoma, Stage IINSCLCNon Small Cell Lung CancerNon-Squamous Non-Small Cell Lung Cancer

Phase 1

Assessment of PK Similarity of FYB206 in Comparison With Keytruda in Resected Stage II or III Melanoma Patients

Active, not recruitingNCT06551064

Formycon AGMelanoma, Stage II, Melanoma Stage III

Start: 2024-07-01End: 2026-06-30Updated: 2025-09-04

Phase 3

A Multicenter, Randomized, Double-blind Trial to Demonstrate Similar Efficacy, Safety, and Immunogenicity of FYB206 (Keytruda Biosimilar Candidate) in Comparison to Keytruda (Pembrolizumab) as an Add-on to Chemotherapy in Treatment-naïve Patients with Metastatic Non-squamous Non-small Cell Lung Cancer (LOTUS)

CompletedCTIS2023-509766-37-00

Formycon AGNSCLC

End: 2025-02-18Target: 81Updated: 2024-08-26

Similar Efficacy, Safety, and Immunogenicity of FYB206 in Comparison to Keytruda as add-on to Chemotherapy in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC)

TerminatedNCT06643117

Formycon AGNon Small Cell Lung Cancer, Non-Squamous Non-Small Cell Lung Cancer

Start: 2024-10-03End: 2025-05-13Updated: 2025-06-26