OncoMatch/Clinical Trials/NCT06908304
A Phase III Study With THIO + Cemiplimab vs Chemotherapy as 3rd Line Treatment in Advanced/Metastatic NSCLC
Is NCT06908304 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for carcinoma, non-small -cell lung.
Treatment: 6-Thio-2'-Deoxyguanosine · Cemiplimab · Docetaxel · Vinorelbine · Gemcitabine alone — 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 3B, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy — advanced/metastatic
including an ICI (anti-PD-1/PD-L1)
Must have received: anti-PD-L1 therapy — advanced/metastatic
including an ICI (anti-PD-1/PD-L1)
Must have received: platinum-based chemotherapy — advanced/metastatic
and a platinum-based chemotherapy (given in combination or in separate lines) for advanced/metastatic disease
Cannot have received: targeted therapy for driver mutations
No prior targeted therapy for driver mutations.
Cannot have received: cemiplimab (cemiplimab)
Prior treatment with cemiplimab.
Cannot have received: EGFR tyrosine kinase inhibitor
Prior treatment with a targeted therapy for an epidermal growth factor receptor (EGFR) mutation.
Cannot have received: allogeneic hematopoietic stem cell transplant
Prior allogeneic hematopoietic stem cell transplant or solid organ transplant.
Cannot have received: solid organ transplant
Prior allogeneic hematopoietic stem cell transplant or solid organ transplant.
Lab requirements
Blood counts
Neutrophil count ≥ 1500/mm3, hemoglobin ≥ 9.0 g/dL, platelet count ≥ 100,000/mm3
Kidney function
Creatinine clearance (CrCl) ≥ 60 mL/min calculated by Cockcroft-Gault or 24-hour urine collection
Liver function
Total bilirubin ≤ 1.5 x ULN (≤ 3 × ULN if due to Gilbert's syndrome); ALT and AST ≤ 1.5 × ULN (≤ 3 × ULN if liver metastases present)
Demonstrate adequate organ function as defined below. 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 if 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 (CrCl) ≥ 60 mL/min calculated by the Cockcroft-Gault formula using actual body weight or 24-hour urine collection.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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