🏛️ 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: To join this study, participants generally need to meet the listed inclusion criteria (20 items) and avoid the listed exclusions (29 items).

Location: Central Alabama Research — Birmingham, Alabama

Age range: 18 Years

🧪 Interventions in This Study

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

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria
  • Have not recovered from adverse events (must be Grade ≤ 1) due to prior anti-cancer treatment.
  • Untreated or symptomatic central nervous system (CNS) metastases. Note: subjects with treated asymptomatic brain metastasis are eligible.
  • Active gastrointestinal bleeding as evidenced by either hematemesis or melena.
  • History of another concurrent malignancy other than the present condition (except nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 3 years.
  • A condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, adrenal replacement doses 10 mg daily prednisone equivalents, and systemic corticosteroids to manage adverse events (AEs) are permitted in the absence of active autoimmune disease.
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy within 2 weeks of screening.
  • Positive for Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active hepatitis B or hepatitis C.
  • Significant cardiovascular impairment (history of New York Heart Association Functional Classification System Class III or IV) or a history of myocardial infarction or unstable angina within the past 6 months prior to IP initiation. a) QTcF \> 480 msec at screening (based on average of triplicate ECGs at baseline). i. If the QTc is prolonged in a subject with a pacemaker or bundle branch block, the subject may be enrolled in the study if confirmed by the Medical Monitor.
  • Ongoing immune-related/stimulated adverse events (irAEs) from other agents or required permanent discontinuation of prior ICIs due to irAEs. Subjects with resolved irAE may be allowed to enroll following consultation with Sponsor's Medical Monitor (or designee).
  • Active autoimmune diseases or history of autoimmune diseases that may relapse, with the following exceptions:
  • Controlled type 1 diabetes;

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 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 ↗