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AzTrials

Advanced Non-squamous Non-small-cell Lung CancerPhase 2VIRO-25NCT06463665

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

A Phase 2 study testing Olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin and Non-platinum chemotherapy: paclitaxel or nab-paclitaxel for squamous cell NSCLC or pemetrexed for nonsquamous cell NSCLC in people with Advanced Non-squamous Non-small-cell Lung Cancer and Advanced Squamous Non-Small Cell Lung Carcinoma, run by Genelux Corporation at 15 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin and Non-platinum chemotherapy: paclitaxel or nab-paclitaxel for squamous cell NSCLC or pemetrexed for nonsquamous cell NSCLC
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
15 sitesUnited States
Study dates
26 Sep 2024to Jul 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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).
Show all 14Show fewer
  • 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.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

15 sites in 1 country

United States15 sites, 15 recruiting

  • Texas Oncology - Austin Central

    Austin, Texas, 78745

    Marian Heaven, BSN, 512-427-9400, Marian.heaven@usoncology.com

    James Uyeki, MD

    Recruiting

  • World Research Link

    Baytown, Texas, 77521

    Isabel Navarrete, 833-832-8328, isabel.navarrete@worldresearchlink.com

    Dustyn Tobin, MD, 833-832-8328, dr.tobin@worldresearchlink.com

    Recruiting

  • Pioneer Research Center, LLC

    Bullhead City, Arizona, 86442

    Hamdy Mohtaseb, MD, 928-216-4560, hmohtaseb@azcancerandblood.com

    Hamdy Mohtaseb, MD

    Recruiting

  • Gabrail Cancer and Research Center

    Canton, Ohio, 44718

    Carrie Smith, 330-492-3345 ext. 208, csmith@gabrailcancercenter.com

    Kim Roby, 330-492-3345 ext. 227, kroby@gabrailcancercenter.com

    Recruiting

  • Clermont Oncology Center

    Clermont, Florida, 34711

    Kiran Penta, 386-538-3169, kiran@aorcorp.com

    Gopal Kunta, MD

    Recruiting

  • Oncology & Hematology Associates of West Broward

    Coral Springs, Florida, 33065

    Sumit Sawhney, MD, 954-726-0035, sumit@bellsouth.net

    Sumit Sawhney, MD

    Recruiting

  • Michigan Hematology and Oncology Consultants

    Dearborn, Michigan, 48126

    Heather Austin, 585-216-7617, heather.austin@profoundresearch.com

    Faisel Musa, MD

    Recruiting

  • Oakland Medical Group

    Farmington Hills, Michigan, 48336

    Catherine Maples, 517-375-3057, Catherine.Maples@profoundresearch.com

    Jeffrey Margolis, MD

    Recruiting

  • Helios Clinical Research

    Fort Lauderdale, Florida, 33316

    Kylee Charlemagne, 645-225-9003, kylee.charlemagne@heliosclinical.com

    Edgardo Santos, MD

    Recruiting

  • Bioresearch Partner

    Hialeah, Florida, 33013

    Jenrrys Mejias, 833-489-4968, jmejias@bioresearchpartner.com

    Jonathan Matias, 833-489-4968, jmatias@bioresearchpartner.com

    Recruiting

  • University of Miami - Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

    Richa Dawar, MD, 954-461-2107, richa.dawar@med.miami.edu

    Richa Dawar, MD

    Recruiting

  • Bioresearch Partner

    Miami, Florida, 33155

    Handy Del Sol Bello, 833-489-4968, handy@bioresearchpartner.com

    Marianna Wefer, 833-489-4968, mwefer@bioresearchpartner.com

    Recruiting

  • Inspira Medical Center Mullica Hill

    Mullica Hill, New Jersey, 08062

    Research, 856-641-6989, research@ihn.org

    Erev Tubb, MD

    Recruiting

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida, 32763

    Kiran Penta, 386-538-3169, kiran@aorcorp.com

    Santosh Nair, MD

    Recruiting

  • BRCR Medical Center, Inc.

    Plantation, Florida, 33322

    Anamaria Astudillo, 561-447-0614, anamariaa@brcrglobal.com

    Harshad Amin, MD

    Recruiting

Other trials in United States

About this study

Official title: A Randomized Phase 2 Study Assessing the Efficacy and Safety of Olvimulogene Nanivacirepvec Followed by Platinum-doublet Chemotherapy + Physician's Choice of Immune Checkpoint Inhibitor Compared With Docetaxel in Patients With NSCL Cancer After First Progression While on Front-line Immune Checkpoint Inhibitor-based Maintenance

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.

Read the detailed description

Olvi-Vec (olvimulogene nanivacirepvec, aka GL-ONC1; laboratory name: GLV-1h68) is an oncolytic vaccinia virus-based immunotherapy that has been shown to have broad infectivity in a wide range of tumor types including non-small-cell lung cancer (NSCLC). In preclinical studies, Olvi-Vec was shown to infect and kill NSCLC cells and tumors in vitro and in vivo, respectively, and resolved and prevented formation of malignant effusion. This study is to test the hypothesis that the combination of Olvi-Vec followed by further platinum-based chemotherapy plus an ICI is particularly effective against established tumors by virus-mediated immune activation and re-sensitization of tumor cells to chemotherapy. Participants will have advanced or metastatic NSCLC (Stage III or Stage IV) squamous or nonsquamous disease without known targetable alterations in Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK) or Repressor of Silencing 1 (ROS1). Eligible patients will have first disease progression by radiological assessment (i) while on front-line platinum-doublet chemotherapy and ICI, or (ii) while receiving front-line maintenance ICI-based therapy after completion of front-line therapy, with at least 2 cycles and maximum of 6 cycles of platinum-doublet chemotherapy and ICI, regardless of Programmed death-ligand 1 (PD-L1) expression as the first treatment after being diagnosed. ICI includes anti-programmed death-1 (anti-PD-1) or anti-PD-L1 agents. Other classes of ICI [e.g., anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4), etc.] are excluded. Patients will be stratified based on length of time on ICI-based therapy from start date of the first dose, if ICI during front-line therapy, until date of first progression by radiological assessment is either less than or equal to 4 months or greater than 4 months. Patients enrolled in one of the initial 3 cohorts will receive either 3 or 4 days of Olvi-Vec followed by platinum-doublet chemotherapy + Physician's Choice of ICI. The randomization part of the study will start afterwards with the Olvi-Vec dose and schedule selected from one of the 3 cohorts for the Experimental Arm. The Active Comparator Arm (ACA) treatment includes docetaxel. Participants treated in the ACA who subsequently have documented disease progression may cross-over for treatment as per the Experimental Arm following determination of eligibility.

Being tested
Olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: paclitaxel or nab-paclitaxel for squamous cell NSCLC or pemetrexed for nonsquamous cell NSCLC, Physician's Choice of Immune Checkpoint Inhibitor: pembrolizumab, nivolumab, cemiplimab, atezolizumab, durvalumab, Docetaxel
Keywords
Olvi-Vec, virotherapy, viral therapy, immunotherapy, immunochemotherapy, combination therapy, vaccinia virus, platinum-doublet chemotherapy, pembrolizumab, nivolumab, cemiplimab, atezolizumab, durvalumab, anti-PD-1, anti-PD-L1, carboplatin, cisplatin, docetaxel, neoplasms by site, neoplasms
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Vaccinia, Neoplasms by Site, Neoplasms, Carcinoma, Neoplasms by Histologic Type

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Olvimulogene nanivacirepvecBiological

    Also called Olvi-Vec, GL-ONC, GLV-1h68

    Olvi-Vec is an engineered oncolytic vaccinia virus

  • Platinum chemotherapy: carboplatin or cisplatinDrug

    Also called Brand of drug is based on institutional procurement

    Administered according to local practice.

  • Non-platinum chemotherapy: paclitaxel or nab-paclitaxel for squamous cell NSCLC or pemetrexed for nonsquamous cell NSCLCDrug

    Also called Brand of drug is based on institutional procurement

    Administered according to local practice.

  • Physician's Choice of Immune Checkpoint Inhibitor: pembrolizumab, nivolumab, cemiplimab, atezolizumab, durvalumabDrug

    Also called Brand of drug is based on institutional procurement

    Administered according to local practice.

  • DocetaxelDrug

    Also called Brand of drug is based on institutional procurement

    Administered according to local practice.

Study groups in NCT06463665
Study groupRoleWhat they receive
Single-arm run-in Olvi-Vec dose escalation CohortsExperimentalCohort 1: Olvi-Vec administered over 3 consecutive days at 0.5,0.5,0.5 x 10e9 pfu followed 2 to 3 weeks later with platinum-doublet chemotherapy + Physician's Choice of ICI. Cohort 2: Olvi-Vec administered over 3 consecutive days at 1,1,1 x 10e9 pfu followed 2 to 3 weeks later with platinum-doublet chemotherapy + Physician's Choice of ICI. Cohort 3: Olvi-Vec administered over 4 consecutive days at 1,2,3 x 10e9 pfu followed 2 to 3 weeks later with platinum-doublet chemotherapy + Physician's Choice of ICI.
Receives: 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
Experimental ArmExperimentalOlvi-Vec will be administered at the dose and schedule selected from the single-arm run-in Olvi-Vec dose escalation cohorts followed 2 to 3 weeks later with platinum-doublet chemotherapy + Physician's Choice of ICI.
Receives: 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
Active Comparator ArmActive comparatorDocetaxel starts in Week 0 and continues until disease progression is assessed by the BICR.
Receives: Drug: Docetaxel
Active Comparator Arm Cross-overOtherPatients randomized into the Active Comparator can cross-over to receive the same treatment as given in the Experimental Arm following determination of (1) disease progression by BICR after receiving docetaxel treatment and (2) confirming eligibility.
Receives: 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; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Central Review (BICR)

    To assess progression-free survival from time of randomization until first documented disease progression based on radiological assessment or death from any cause.

    Measured: From date of randomization up to 12 months.

Secondary outcomes (6)

  1. Objective Response Rate (ORR) by RECIST 1.1

    Ratio of the sum of complete responses (CR) \& partial responses (PR) divided by the number of participants from start of treatment to confirmation of response.

    Measured: From date of randomization up to 12 months.

  2. Median Overall Survival

    Time from randomization until death or study completion; assessed up to 36 months.

    Measured: From date of randomization up to 36 months.

  3. Six-month Progression-free Survival Rate

    Proportion of patients who remained alive and progression-free at 6 months.

    Measured: From date of randomization up to 6 months.

  4. Incidence of Treatment-emergent Adverse Events

    From date of first study treatment until death or study completion.

    Measured: Assessed up to 36 months.

  5. Duration of Response by RECIST 1.1

    Time from date of first response until the first date of progressive disease based on radiological assessment.

    Measured: From date of randomization up to 12 months.

  6. Disease Control Rate (DCR)

    Percentage of patients who have achieved complete response, partial response or stable disease out of the total number of patients evaluated in a therapeutic intervention in clinical trials: DCR = [CR + PR + SD (stable disease)]/total # of patients evaluated by RECIST 1.1.

    Measured: From date of randomization up to 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2024
  2. Study start26 Sep 2024
  3. Primary completionFeb 2027 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Following selection of the dose and schedule from the three safety run-in cohorts, randomization is (1:1) either into the Experimental Arm (EA) which is Olvi-Vec with platinum-doublet + Physician's Choice of ICI and then ICI-based maintenance or in the Active Comparator Arm (ACA) which includes treatment with docetaxel. ACA patients with documented disease progression \[i.e., assessed by Blinded Independent Central Review (BICR)\] who are eligible may crossover to receive the same treatment as per the Experimental Arm.
Masking
None (open label)
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06463665
Sponsor's protocol ID
Olvi-Vec-NSCLC-025
Acronym
VIRO-25
Status last verified
Jun 2026
First submitted
11 Jun 2024
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin and Non-platinum chemotherapy: paclitaxel or nab-paclitaxel for squamous cell NSCLC or pemetrexed for nonsquamous cell NSCLC in people with Advanced Non-squamous Non-small-cell Lung Cancer and Advanced Squamous Non-Small Cell Lung Carcinoma, run by Genelux Corporation at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06463665.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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