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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
Started
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Record History

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  1. Study sites: 16 to 15v17
  2. Study sites: 13 to 16v16
  3. Study sites: 12 to 13v15
  4. Site contacts updated at 3 of 12 sitesv14
  5. Study sites: 11 to 12v13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 10 to 11v12
  2. Study sites: 9 to 10v11
  3. Study sites: 8 to 9v10
  4. Study sites: 7 to 8v9
  5. Study sites: 5 to 7v8
  6. Study sites: 4 to 5v7
  7. Study sites: 1 to 4v6
  8. Site contact updated
    • Study title shortened, about 1 word
    v5
  9. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2024 to Sep 26, 2024
    v4
  10. Start date: Jul 2024 to Sep 2024v3
  11. Primary endpoint revisedv2 Show 4 more changesShow less
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 2 of 6 entries
    • Study description expanded, about 20 words
    • Study title revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06463665
Lead Sponsor Genelux Corporation
Collaborators: Newsoara Biopharma Co., Ltd.
Conditions
(from sponsor)		 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
Related terms Carcinoma, Carcinoma, Non-Small-Cell Lung, Neoplasms, Neoplasms by Histologic Type, Neoplasms by Site, Vaccinia
Enrollment 142 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov