Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 Versus Keytruda® in Stage IV NSCLC

PHASE3RecruitingINTERVENTIONAL
Enrollment

174

Participants

Timeline

Start Date

August 15, 2023

Primary Completion Date

August 31, 2024

Study Completion Date

December 31, 2024

Conditions
Non Small Cell Lung Cancer Metastatic
Interventions
DRUG

Pembrolizumab

Study drug administration: intravenous infusion Dosing instructions: 200 mg administered over 30 minutes, every 3 weeks The time for infusion should be closer to 30 minutes. However, considering the variability of the infusion pumps from one center to another, a -5 to +10 minutes window is allowed (ie, the time for infusion is 30 minutes with an allowed range of 25 to 40 minutes).

DRUG

Pembrolizumab biosimilar

Study drug administration: intravenous infusion Dosing instructions: 200 mg administered over 30 minutes, every 3 weeks The time for infusion should be closer to 30 minutes. However, considering the variability of the infusion pumps from one center to another, a -5 to +10 minutes window is allowed (ie, the time for infusion is 30 minutes with an allowed range of 25 to 40 minutes).

Trial Locations (1)

5300

RECRUITING

Clínica Viedma, Viedma

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Syneos Health

OTHER

lead

Laboratorio Elea Phoenix S.A.

INDUSTRY

NCT05668650 - Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 Versus Keytruda® in Stage IV NSCLC | Biotech Hunter | Biotech Hunter