OncoMatch/Clinical Trials/NCT05208944
THIO Sequenced With Cemiplimab in Advanced NSCLC
Is NCT05208944 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including 6-Thio-2'-Deoxyguanosine and Cemiplimab for carcinoma, non-small-cell lung.
Treatment: 6-Thio-2'-Deoxyguanosine · Cemiplimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Disease stage
Required: Stage III, IV
Stage 3 or 4 histologically or cytologically confirmed NSCLC which has progressed or relapsed after treatment in the advanced setting
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: immune checkpoint inhibitor — advanced
Subjects must have secondary resistance to the prior ICI, as defined by the Society for Immunotherapy of Cancer (SITC) Immunotherapy Resistance Task Force (IRTF) (Kluger 2020)
Cannot have received: targeted therapy for driver mutations
No prior targeted therapy for driver mutations.
Cannot have received: cemiplimab (cemiplimab)
Exception: Part C and Part D: prior cemiplimab is permitted.
Part A and Part B: Prior treatment with cemiplimab. Note: Part C and Part D: prior cemiplimab is permitted.
Lab requirements
Blood counts
Neutrophil count ≥ 1500/mm3, hemoglobin ≥ 9.0 g/dL, platelet count ≥ 100,000/mm3
Kidney function
Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault or 24-hour urine collection)
Liver function
Total bilirubin ≤ 1.5 x ULN (≤ 3 × ULN due to Gilbert's syndrome); ALT and AST ≤ 1.5 × ULN (≤ 3 × ULN with liver metastases)
Cardiac function
QTcF > 480 msec at screening (based on average of triplicate ECGs at baseline) excluded
Bone marrow function: Neutrophil count ≥ 1500/mm3, hemoglobin ≥ 9.0 g/dL, platelet count ≥ 100,000/mm3; Liver function: Total bilirubin ≤ 1.5 x ULN, up to ≤ 3 × ULN due to Gilbert's syndrome; ALT and AST ≤ 1.5 × ULN. For subjects with liver metastases present at baseline, ALT and/or AST ≤ 3 × ULN is permitted. Renal function: Creatinine clearance ≥ 60 mL/min calculated by the Cockcroft-Gault formula using actual body weight or 24-hour urine collection. QTcF > 480 msec at screening (based on average of triplicate ECGs at baseline) excluded.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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