OncoMatch/Clinical Trials/NCT05344209
Efficacy and Safety of Anti-PD-1/PD-L1 Treatment +/- UV1 Vaccination in Patients With Non-small Cell Lung Cancer
Is NCT05344209 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including UV1 and Sagramostim for oncology.
Treatment: UV1 · Sagramostim · Anti-PD-1/PD-L1 treatment — A Randomized, Multicenter Study Investigating Efficacy and Safety of anti-PD-1/PD-L1-treatment +/- UV1 vaccination as first line treatment in patients with inoperable advanced or metastatic non-small cell lung cancer. The objective of the phase 2 study is to induce a meaningful Progression-Free Survival (PFS) benefit in patients with stage IIIB/IIIC or stage IV NSCLC by treating with anti-PD-1/PD-L1 treatment and UV1 vaccination versus anti-PD-1/PD-L1 treatment alone.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) overexpression (PD-L1 ≥ 50%)
PD-L1 ≥ 50% measured by a validated method
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-PD-1 therapy (pembrolizumab)
Previous treatment with a PD-1 or PD-L1 inhibitor, including pembrolizumab or any other agent targeting immune checkpoints
Cannot have received: anti-PD-L1 therapy
Previous treatment with a PD-1 or PD-L1 inhibitor, including pembrolizumab or any other agent targeting immune checkpoints
Lab requirements
Blood counts
Haemoglobin ≥9.0 g/dL; ANC >1500 per mm3; Platelet count ≥100 x 10^9/L (>75,000 per mm3)
Kidney function
Measured or calculated creatinine clearance >40 mL/min (Cockcroft-Gault or 24-hour urine collection)
Liver function
Serum bilirubin ≤1.5 x institutional ULN; AST (SGOT)/ALT (SGPT) ≤2.5 x ULN unless liver metastases are present, in which case ≤5x ULN
Adequate organ function as defined below Haemoglobin ≥9.0 g/dL Absolute neutrophil count (ANC) >1500 per mm3 Platelet count ≥100 x 10^9/L (>75,000 per mm3) Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL >40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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