NCT06463665 · Genelux Corporation
Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer
(VIRO-25)
What this study is about
This Phase 2, where both patients and doctors know the treatment given, randomly assigned study in non-small-cell lung cancer (NSCLC) is designed to evaluate the effectiveness and safety of an given through a vein (IV) delivered oncolytic vaccinia virus, Olvi-Vec, followed by platinum-doublet chemotherapy + Physician's Choice of Immune Checkpoint Inhibitor (ICI) vs.
View original scientific description
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.
Interventions
BIOLOGICAL
Olvimulogene nanivacirepvec
Olvi-Vec is an engineered oncolytic vaccinia virus
DRUG
Platinum chemotherapy: carboplatin or cisplatin
Administered according to local practice.
DRUG
Non-platinum chemotherapy: paclitaxel or nab-paclitaxel for squamous cell NSCLC or pemetrexed for nonsquamous cell NSCLC
Administered according to local practice.
DRUG
Physician's Choice of Immune Checkpoint Inhibitor: pembrolizumab, nivolumab, cemiplimab, atezolizumab, durvalumab
Administered according to local practice.
DRUG
Docetaxel
Administered according to local practice.
Primary outcome measures
Progression-free Survival per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Central Review (BICR)
Time frame: From date of randomization up to 12 months.
To assess progression-free survival from time of randomization until first documented disease progression based on radiological assessment or death from any cause.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female 18 years or older.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
- Have histologically or cytologically confirmed advanced or metastatic NSCLC.
- Histologically confirmed Stage III or IV squamous or nonsquamous \[American Joint Committee on Cancer (AJCC) 8th edition\].
- Received at least 2 cycles and maximum of 6 cycles of front-line platinum-based chemotherapy with ICI-based therapy, regardless of PD-L1 expression.
- Reached first disease progression by radiological assessment while receiving front-line or maintenance ICI.
- At least one measurable target tumor lesion anywhere except the brain per RECIST 1.1 by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan.
- Have adequate renal, hepatic, bone marrow function as well as adequate coagulation tests \[International Normalized Ratio (INR)\] and adequate immune function by lymphocyte count.
- Women of child-bearing potential must have a negative serum pr
Where
- Bullhead City, Arizona
- Clermont, Florida
- Coral Springs, Florida
- Fort Lauderdale, Florida
- Hialeah, Florida
- Miami, Florida
- Orange City, Florida
- Plantation, Florida
- Dearborn, Michigan
- Farmington Hills, Michigan
- Mullica Hill, New Jersey
- Canton, Ohio
And 2 more locations — see the full list below.
Collaborators
Newsoara Biopharma Co., Ltd.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations