🏛️ Verified NIH Record • Updated 2026-05-11

THIO Sequenced With Cemiplimab in Advanced NSCLC (NCT05208944)

A Multicenter, Open-Label, Dose-Finding, Phase 2 Study Evaluating THIO Sequenced With Cemiplimab (LIBTAYO®) in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Maia Biotechnology

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

THIO is a first-in-class small molecule telomere targeting agent, in development for the treatment of non-small cell lung cancer (NSCLC) in combination with cemiplimab (LIBTAYO®). THIO is preferentially incorporated into telomeres sequence in telomerase-positive cells leading to rapid telomere uncapping, genomic instability, and cell death. Cemiplimab is a programmed cell death protein 1 (PD-1) inhibitor recently approved as a first-line treatment for patients with locally advanced or metastatic NSCLC with 50% or more PD-L1 expression. It is hypothesized that THIO administration prior to cemiplimab would restore tumor responses to immunotherapy in subjects who either developed resistance or relapsed after receiving first line treatment with an immune check point inhibitor.

Who can join: Review the eligibility criteria below.

Location: Central Alabama Research — Birmingham, Alabama

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 (35 Sites)

Showing the first 25 of 35 sites.

  • Central Alabama Research — Birmingham, Alabama
  • Summit Health — Florham Park, New Jersey
  • Sunshine Coast Haematology and Oncology Clinic — Buderim, Queensland
  • Cancer Research SA — Adelaide, South Australia
  • St. Vincent Hospital Melbourne — Fitzroy, Victoria
  • MHAT "HEART AND BRAIN" EAD Clinic of Medical Oncology — Pleven,
  • MC Synexus Sofia EOOD — Sofia,
  • MHAT "Serdika" EOOD — Sofia,
  • UMHAT "Sofiamed" — Sofia,
  • Semmelweis Egyetem Pulmonologiai Klinika — Budapest,
  • Országos Korányi Pulmonológiai Intézet — Budapest,
  • Orszagos Onkologiai Intezet — Budapest,
  • Debreceni Egyetem Klinikai Kozpont, Tudogyogyaszati Klinika — Debrecen,
  • Bács-Kiskun Megyei Oktatókórház, Onkoradiológiai Központ — Kecskemét,
  • Mátrai Gyógyintézet — Mátraháza,
  • Hetenyi Geza Korhaz, Onkologiai Kozpont — Szolnok,
  • Tüdőgyógyintézet Törökbálint, Onkológiai Osztályc — Törökbálint,
  • NZOZ FORMED 2 Sp. z o.o. — Oświęcim, Oswiecim
  • Centrum Onkologii im. prof. F. Lukaszczyka — Bydgoszcz,
  • Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Onkologii z Pododdzialem Diagnostyki Nowotworow Klatki Piersiowej — Krakow,
  • Centrum Terapii Współczesnej J. M. Jasnorzewska — Lodz,
  • NeuroMed — Lublin,
  • Med Polonia Sp z o.o. — Poznan,
  • Centrum Medyczne Mrukmed — Rzeszów,
  • Centrum Medyczne Pratia — Skorzewo,

💰 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.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  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 ↗