Back to search results
NCT05208944

THIO Sequenced With Cemiplimab in Advanced NSCLC

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Maia Biotechnology
~227 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:6-Thio-2'-DeoxyguanosineCemiplimab

At a glance

Recruiting sites
0 of 35 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine the safety and tolerability of THIO administered in sequence with cemiplimab in subjects with advanced NSCLC
Measured over Up to 2 years
+4 more outcomes measured

Conditions

Carcinoma, Non-Small-Cell Lung

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

35 sites across 17 states
Hungary8
Poland8
Bulgaria4
Turkey (Türkiye)2
Alabama1
New Jersey1
Queensland1
South Australia1

Study leadership

  • Victor Zaporojan, MD · STUDY_CHAIR · Maia Biotechnology

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Prior treatment may have been with anti-PD-1/PD-L1 agent either alone or in combination with a non-anti-PD-1/PD-L1 treatment (e.g., chemotherapy)
Prior platinum-based chemotherapy is not required for eligibility.
Subjects receiving more than one ICI in the advanced setting (e.g., anti-PD-1/PD-L1 and anti-CTLA-4 compounds) will not be eligible.
Total bilirubin ≤ 1.5 x the upper limit of normal (ULN), up to ≤ 3 × ULN due to Gilbert's syndrome
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN. For subjects with liver metastases present at baseline, ALT and/or AST ≤ 3 × ULN is permitted.

Exclusion

Controlled type 1 diabetes;
Hypothyroidism (provided it is managed with hormone replacement therapy only);
Controlled celiac disease;
Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia);
Any other disease that is not expected to recur in the absence of external triggering factors. 11. Pregnancy or lactating. 12. A serious nonmalignant disease (e.g., psychiatric, substance abuse, uncontrolled intercurrent illness, etc.) that could compromise protocol objectives in the opinion of the investigator and/or the Sponsor. 13. Any other condition that, in the opinion of the investigator, would prohibit the subject from participating in the study.

What this trial measures

  • To determine the safety and tolerability of THIO administered in sequence with cemiplimab in subjects with advanced NSCLCUp to 2 years

    Part A: Incidence of DLTs

  • To assess the efficacy of THIO administered in sequence with cemiplimab in subjects with advanced NSCLCUp to 2 years

    ORR, defined as the proportion of subjects with either a CR or PR, as assessed by the investigator based on RECIST v1.1

  • To assess the efficacy of THIO administered in sequence with cemiplimab in subjects with advanced NSCLCUp to 2 years

    DCR defined as the proportion of subjects with CR, PR, or SD, as assessed by the investigator based on RECIST v1.1

  • To determine the safety and tolerability of THIO administered in sequence with cemiplimab in subjects with advanced NSCLCUp to 2 years

    Part A: Incidence of DLTs Part A and Part B: Incidence of SAEs overall, by severity, by relationship to THIO and/or cemiplimab, and those that led to discontinuation of THIO and cemiplimab and/or withdrawal from study

  • To determine the safety and tolerability of THIO administered in sequence with cemiplimab in subjects with advanced NSCLCUp to 2 years

    Part A and Part B: Incidence of TEAEs overall, by severity, by relationship to THIO and/or cemiplimab, and those that led to discontinuation of THIO and cemiplimab and/or withdrawal from study