NCT05208944Phase 2Active not recruiting

THIO Sequenced With Cemiplimab in Advanced NSCLC

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2027-09-30Estimated

Enrollment · participants227Estimated

Source updated2026-09-16Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-05-13 · 1 field changed

Recruitment status changed

− Before

~~Recruiting~~

+ After

Active not recruiting

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Posted 2026-01-20 · 1 field changed

Primary completion date changed

− Before

~~30 Jun 2026~~

+ After

30 Sep 2027

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Study details

Conditions studied

Carcinoma, Non-Small-Cell Lung

Treatments or interventions studied

6-Thio-2'-DeoxyguanosineDrugAlso known as 6-thio-dG, THIO
CemiplimabDrugAlso known as LIBTAYO®

Primary outcomes · main study measures

Read the study measures

measure: To determine the safety and tolerability of THIO administered in sequence with cemiplimab in subjects with advanced NSCLC; description: Part A: Incidence of DLTs; timeFrame: Up to 2 years; measure: To assess the efficacy of THIO administered in sequence with cemiplimab in subjects with advanced NSCLC; description: ORR, defined as the proportion of subjects with either a CR or PR, as assessed by the investigator based on RECIST v1.1; timeFrame: Up to 2 years; measure: To assess the efficacy of THIO administered in sequence with cemiplimab in subjects with advanced NSCLC; description: DCR defined as the proportion of subjects with CR, PR, or SD, as assessed by the investigator based on RECIST v1.1; timeFrame: Up to 2 years; measure: To determine the safety and tolerability of THIO administered in sequence with cemiplimab in subjects with advanced NSCLC; description: 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; timeFrame: Up to 2 years; measure: To determine the safety and tolerability of THIO administered in sequence with cemiplimab in subjects with advanced NSCLC; description: 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; timeFrame: Up to 2 years

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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