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RECRUITING Phase 2

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

NCT06463665 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Docetaxel
  • BIOLOGICAL Olvimulogene nanivacirepvec
  • DRUG Platinum chemotherapy: carboplatin or cisplatin
  • DRUG Non-platinum chemotherapy: paclitaxel or nab-paclitaxel for squamous cell NSCLC or pemetrexed for nonsquamous cell NSCLC
  • DRUG Physician's Choice of Immune Checkpoint Inhibitor: pembrolizumab, nivolumab, cemiplimab, atezolizumab, durvalumab

Study Locations (16)

Florida

  • Clermont Oncology Center — Clermont
  • Oncology & Hematology Associates of West Broward — Coral Springs
  • Helios Clinical Research — Fort Lauderdale
  • Bioresearch Partner — Hialeah
  • University of Miami - Sylvester Comprehensive Cancer Center — Miami
  • Bioresearch Partner — Miami
  • Mid Florida Hematology and Oncology Center — Orange City
  • BRCR Medical Center, Inc. — Plantation

Michigan

  • Michigan Hematology and Oncology Consultants — Dearborn
  • Oakland Medical Group — Farmington Hills

Texas

  • Texas Oncology - Austin Central — Austin
  • World Research Link — Baytown

Arizona

  • Pioneer Research Center, LLC — Bullhead City

Maryland

  • University of Maryland Medical Center Greenebaum Comprehensive Cancer Center — Baltimore

Ohio

  • Gabrail Cancer and Research Center — Canton

Wisconsin

  • Sheboygan Cancer & Blood Center — Sheboygan

Trial Details

FieldValue
Enrollment Target 142 participants
Start Date 2024-09-26
Est. Completion 2029-07
Phase Phase 2

Sponsor

Genelux Corporation

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06463665

The ClinicalTrials.gov registry entry for NCT06463665 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genelux Corporation, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 8 conditions, with Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions — of which Docetaxel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06463665 reports 16 study locations spanning 7 distinct geographic areas — top geographies include Florida, Michigan, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06463665 about?

NCT06463665 is a clinical study titled "Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer". 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. d...

What is the current status of trial NCT06463665?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2024-09-26. Estimated completion is 2029-07.

What conditions does trial NCT06463665 study?

This clinical trial studies the following conditions: Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage III, Non-small Cell Lung Cancer Stage IV, Advanced Non-squamous Non-small-cell Lung Cancer, Metastatic Squamous Non-Small Cell Lung Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06463665?

The interventions under investigation include: Docetaxel (DRUG), Olvimulogene nanivacirepvec (BIOLOGICAL), Platinum chemotherapy: carboplatin or cisplatin (DRUG), Non-platinum chemotherapy: paclitaxel or nab-paclitaxel for squamous cell NSCLC or pemetrexed for nonsquamous cell NSCLC (DRUG), Physician's Choice of Immune Checkpoint Inhibitor: pembrolizumab, nivolumab, cemiplimab, atezolizumab, durvalumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06463665?

This trial is sponsored by Genelux Corporation, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06463665 being conducted?

This trial has 16 study locations across Arizona, Florida, Maryland, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial