🏛️ Verified NIH Record • Updated 2026-08-26

A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study) (NCT06687369)

Randomized, Multicenter, Multinational, Double-Blind Study to Compare the Pharmacokinetics, Efficacy, Safety and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) Versus Keytruda® in Combination With Chemotherapy for the Treatment of Patients With Advanced Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (BENITO Study)

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: mAbxience Research S.L.

🩺 Plain-English Summary (8th-Grade Level)

This is a randomized, multicenter, multinational, double-blind, integrated pharmacokinetics (PK) and efficacy similarity study to compare the PK, efficacy, safety, and immunogenicity of MB12 versus Keytruda® in combination with pemetrexed-platinum chemotherapy as first-line treatment in patients with metastatic non-squamous NSCLC.

Who can join: Review the eligibility criteria below.

Location: Site 101001 — Yerevan

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (173 Sites)

Showing the first 25 of 173 sites.

  • Site 101001 — Yerevan,
  • Site 101002 — Yerevan,
  • Site 101003 — Yerevan,
  • Site 101004 — Yerevan,
  • Site 103001 — Sarajevo,
  • Site 103002 — Tuzla,
  • Site 103003 — Zenica,
  • Site 301014 — Barretos,
  • Site 301026 — Belém,
  • Site 301002 — Belo Horizonte,
  • Site 301023 — Bento Gonçalves,
  • Site 301006 — Blumenau,
  • Site 301019 — Caxias do Sul,
  • Site 301015 — Curitiba,
  • Site 301028 — Curitiba,
  • Site 301024 — Florianópolis,
  • Site 301010 — Fortaleza,
  • Site 301011 — Ijuí,
  • Site 301008 — Itajaí,
  • Site 301012 — Jaú,
  • Site 301018 — Natal,
  • Site 301003 — Porto Alegre,
  • Site 301005 — Porto Alegre,
  • Site 301007 — Porto Alegre,
  • Site 301016 — Porto Alegre,

📞 Contact the Study Coordinator

Phone: +34917711500

Email: Susana.Millan@mabxience.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Non Squamous Non Small Cell Lung Cancer clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗