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NCT06463665 · ClinicalTrials.gov record · last posted 2026-06-04

Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer

Study acronym: VIRO-25
StatusRecruiting
PhasePhase 2
Started2024-09-26
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from the ClinicalTrials.gov record
This Phase 2, open-label, randomized study in non-small-cell lung cancer (NSCLC) is designed to evaluate the efficacy and safety of an intravenously delivered oncolytic vaccinia virus, Olvi-Vec, followed by platinum-doublet chemotherapy + Physician's Choice of Immune Checkpoint Inhibitor (ICI) vs. docetaxel for patients with advanced or metastatic NSCLC who have shown first disease progression (i.e., progressive disease not yet confirmed by further scan after initial scan showing progression) while on front-line treatment or maintenance ICI therapy after front-line treatment with platinum-doublet chemotherapy + ICI as standard of care.

Amendment record 16 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 16 times since 2024-06-13; most recent amendment 2026-06-02. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2024-09-26
Status change Not Yet Recruiting→Recruitingv3
Trial Details
NCT Number NCT06463665
Lead Sponsor Genelux Corporation
Collaborators: Newsoara Biopharma Co., Ltd.
Conditions Advanced Non-squamous Non-small-cell Lung Cancer, Advanced Squamous Non-Small Cell Lung Carcinoma, Metastatic Non-squamous Non Small Cell Lung Cancer, Metastatic Squamous Non-Small Cell Lung Carcinoma, Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage III, Non-small Cell Lung Cancer Stage IV, Non-small Cell Lung Cancer Recurrent
Enrollment 142 participants
Start Date 2024-09-26
Primary Completion 2027-02 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-04