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NCT06463665 · ClinicalTrials.gov registry record · Phase 2
Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer
A Phase 2 study of Non-Small Cell Lung Cancer and Non-Small Cell Lung Cancer (Stage III), sponsored by Genelux Corporation.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 142
- Enrollment target
- 16
- Study locations
NCT06463665 is a Phase 2 study of Non-Small Cell Lung Cancer and Non-Small Cell Lung Cancer (Stage III) that is actively recruiting participants, run by Genelux Corporation. The registered enrollment target is 142 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (78% lower). The trial reports 16 study locations across 7 states.
The verdict
NCT06463665, a Phase 2 study of Non-Small Cell Lung Cancer and Non-Small Cell Lung Cancer (Stage III), is actively recruiting participants, sponsored by Genelux Corporation.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 142 participants
- Enrollment target
- 16
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2024-09-26 |
| Est. Completion | 2029-07 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (78% lower). The listed sponsor is Genelux Corporation, which has 4 total studies on file at ClinicalTrials.gov.
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.
NCT06463665 reports 16 study locations spanning 7 distinct geographic areas - top geographies include Florida, Michigan, Texas.
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 Non-Squamous Non-Small Cell Lung Cancer.
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).
Who is sponsoring clinical trial NCT06463665?
This trial is sponsored by Genelux Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
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