THIO Sequenced With Cemiplimab in Advanced NSCLC

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Trial sites expanded: 35 → 40 locations Show 4 more changesShow less
    • Interventions: 6-Thio-2'-Deoxyguanosine (Drug), Cemiplimab (Drug) to 6-Thio-2'-Deoxyguanosine (Drug), Cemiplimab (Drug)
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints: details revised at 5 of 11 entries
    • Study description expanded, about 4 words
  2. Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised at 35 of 35 sites
    v11
  3. Study sites: 34 to 35v10
  4. Study sites: 33 to 34v9
  5. Primary completion date: Jun 30, 2026 to Sep 30, 2027
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Active, Not Recruiting to Recruiting
    • Primary completion date: Dec 31, 2025 to Jun 30, 2026
    • Study sites: 27 to 33
    • Study completion date: Oct 31, 2026 to Dec 31, 2026
    v7
  2. Primary endpoints: 3 to 5v6 Show 7 more changesShow less
    • Enrollment target: 182 to 227
    • Study sites: 24 to 27
    • Primary completion date: Aug 31, 2025 to Dec 31, 2025
    • Eligibility criteria shortened, about 106 words
    • Secondary endpoints: 3 to 11
    • Study description expanded, about 27 words
    • Study arms: 3 to 4
  3. Primary completion date: Jun 3, 2024 to Aug 31, 2025v5 Show 6 more changesShow less
    • Primary endpoints: 5 to 3
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 22 to 24
    • Study completion date: Dec 2, 2024 to Oct 31, 2026
    • Eligibility criteria expanded, about 595 words
    • Study description shortened, about 7 words
  4. Study sites: 2 to 22v4
  5. Primary endpoints: 1 to 5
    • Eligibility criteria expanded, about 150 words
    • Secondary endpoints expanded, about 29 words
    • Study title shortened, about 10 words
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Mar 31, 2022 to Jun 8, 2022
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05208944
Lead Sponsor Maia Biotechnology
Conditions
(from sponsor)		 Carcinoma, Non-Small-Cell Lung
Related terms Adenocarcinoma, Carcinoma, Large Cell, Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell
Enrollment 227 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov