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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT05344209 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1 therapy, anti-PD-L1 therapy disqualifies patients from enrollment.
Does this trial require CD274?
Yes, CD274 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify