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)

PHASE3TerminatedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

October 3, 2024

Primary Completion Date

May 13, 2025

Study Completion Date

May 13, 2025

Conditions
Non Small Cell Lung CancerNon-Squamous Non-Small Cell Lung Cancer
Interventions
BIOLOGICAL

FYB206

FYB206 (Keytruda biosimilar candidate - test product) 200 mg administered as an IV infusion over 30 minutes on Day 1 of each cycle combined with chemotherapy in the first year (treatment Cycles 1 to 17)

BIOLOGICAL

FYB206

Open-label treatment with FYB206 combined with chemotherapy (Cycles 18-34) to assure treatment continuation for trial patients up to a total of 2 years (a total of 34 treatment cycles)

BIOLOGICAL

Keytruda

Keytruda (reference product) 200 mg administered as an IV infusion over 30 minutes on Day 1 of each cycle combined with chemotherapy in the first year (treatment Cycles 1 to 17)

Trial Locations (13)

Unknown

Formycon Investigative Site, Batumi

Formycon Investigative Site, Kutaisi

Formycon Investigative Site, Tbilisi

Formycon Investigative Site, George Town

Formycon Investigative Site, Kuala Lumpur

Formycon Investigative Site, Kuching

Formycon Investigative Site, Shah Alam

Formycon Investigative Site, Subang Jaya

Formycon Investigative Site, Adana

Formycon Investigative Site, Diyarbakır

Formycon Investigative Site, Istanbul

Formycon Investigative Site, Izmir

Formycon Investigative Site, Samsun

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Formycon AG

INDUSTRY

NCT06643117 - 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) | Biotech Hunter | Biotech Hunter