Study of Olvimulogene Nanivacirepvec for Advanced Lung Cancer
This study is testing a new treatment for advanced or metastatic non-small cell lung cancer (NSCLC) that has worsened after initial treatment. It compares a combination of olvimulogene nanivacirepvec (an engineered virus), platinum chemotherapy, and a physician's choice of immune checkpoint inhibitor (like pembrolizumab or nivolumab) against docetaxel chemotherapy. The main goal is to see if the new combination can slow down or stop cancer growth more effectively. You may be eligible if you are 18 or older, have advanced NSCLC (Stage III or IV), and your cancer has progressed after previous treatment. The study aims to enroll 142 participants, but its current recruitment status is unclear.
- Study design
- This is a Phase 2, open-label, randomized study. It will compare two treatment approaches in about 142 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main outcome of the study, progression-free survival, will be measured for up to 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06463665
Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentGenelux Corporation
~142 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Olvimulogene nanivacirepvecPlatinum chemotherapy: carboplatin or cisplatinNon-platinum chemotherapy: paclitaxel or nab-paclitaxel for squamous cell NSCLC or pemetrexed for nonsquamous cell NSCLCPhysician's Choice of Immune Checkpoint Inhibitor: pembrolizumab, nivolumab, cemiplimab, atezolizumab, durvalumabDocetaxel
At a glance
Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free Survival per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Central Review (BICR)
Measured over From date of randomization up to 12 months.
Conditions
Where it's being run
15 sites across 6 statesFlorida8
Michigan2
Texas2
Arizona1
New Jersey1
Ohio1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 pregnancy test prior to initiating study dosing.
Be willing and able to comply with scheduled visits, the treatment plan, imaging and laboratory tests.
Exclusion
Active and untreated urinary tract infection, pneumonia, or other systemic infections.
Current symptomatic central nervous system (CNS) metastasis.
Any uncontrolled systemic disease, condition or comorbidity that, in the opinion of the Investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
Persistent toxicities \[Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 3\] caused by previous anticancer therapy; alopecia and vitiligo are excluded toxicities.
Required the use of additional immunosuppression other than corticosteroids for the management of an adverse event or have experienced recurrence of an adverse event if re-challenged, or currently require maintenance doses of \>10 mg prednisone or equivalent per day.
Receiving concurrent antiviral agent active against vaccinia virus (e.g., cidofovir, vaccinia immunoglobulin, imatinib, tecovirimat, or other agents with known anti-vaccinia activities).
Underwent major surgery within 4 weeks, or have insufficient recovery from surgical-related trauma or wound healing, prior to the planned first dose of treatment in either Arm.
Have received prior virus-based gene therapy or therapy with cytolytic virus of any type.
Vaccination against smallpox or monkeypox within 1 year of study therapy.
Any non-oncology vaccine therapy used for prevention of infectious diseases, such as seasonal (influenza) vaccinations, corona virus disease (COVID) vaccination or other vaccines, within 2 weeks of the planned first dose of study drug.
Clinically significant skin disease as assessed by the Investigator (e.g., severe eczema, psoriasis, or any unresolved skin injury or ulcer).
Known hypersensitivity to carboplatin, cisplatin, paclitaxel or nab-paclitaxel, docetaxel, or any of the constituents of Olvi-Vec (i.e., gentamicin).
Had severe hypersensitivity (CTCAE Grade ≥ 3) to ICI and/or any of its excipients previously.
Dementia or altered mental status that would prohibit informed consent, and/or psychiatric illness/social situations that might interfere or limit compliance with study requirements.
What this trial measures
- Progression-free Survival per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Central Review (BICR)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.