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Clinical Trial Summary

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.


Clinical Trial Description

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. Patients are randomized to receive anti-PD-1/PD-L1 treatment until progression or unacceptable toxicity, for a maximum of 2 years, with or without 8 injections of 300 μg UV1 and 75 μg GM-CSF (UV1 vaccination). Patients randomized to UV1 vaccination, will start UV1 vaccination the same day as anti-PD-1/PD-L1 treatment is initiated, followed by three vaccinations over the next ten days. Thereafter, one vaccination per anti-PD-1/PD-L1 treatment cycle (c2-5), totaling to 8 UV1 vaccinations ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05344209
Study type Interventional
Source Vestre Viken Hospital Trust
Contact Odd Terje Brustugun, Md, PhD
Phone 32804029
Email otr@vestreviken.no
Status Recruiting
Phase Phase 2
Start date August 12, 2022
Completion date July 1, 2027

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