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

This is a randomized, multicenter, multinational, double-blind, and parallel-group study to evaluate the PK, efficacy, safety and immunogenicity of MB12 (proposed pembrolizumab biosimilar) versus Keytruda® in subjects with newly diagnosed stage IV non-squamous NSCLC. This study is planned to be conducted in approximately 48 sites in 7 countries, a total of 174 subjects will be enrolled. Eligible subjects will be randomized in a 1:1 ratio to receive MB12 or Keytruda® at a dose of 200 mg every 3 weeks. Subjects will be stratified by gender (male versus female) and ECOG status (0 versus 1) as bo

Trial Details

NCT ID
NCT05668650
Phase
PHASE3
Sponsor
Laboratorio Elea Phoenix S.A.
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Pembrolizumab
  • Pembrolizumab biosimilar
Locations (sample)
  • Viedma, Río Negro Province, Argentina|-40.81519,-63.0004

Key Eligibility Criteria

  • Individuals must meet all of the following criteria to be included in the study:
  • Willing and able to provide written informed consent for the study before the initiation of any study-specific procedures.
  • Greater than or equal to 18 years of age at the time of signing the ICF.
  • Body weight ≥50 kg at Screening.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Non-Small Cell (NSCLC) Lung Cancer Trials on Trialify →