Recruiting
Phase 2

Olvimulogene Nanivacirepvec & Platinum-doublet

Sponsor:

Genelux Corporation

Code:

NCT06463665

Conditions

Advanced Non-squamous Non-small-cell Lung Cancer

Advanced Squamous Non-Small Cell Lung Carcinoma

Metastatic Non-squamous Non Small Cell Lung Cancer

Metastatic Squamous Non-Small Cell Lung Carcinoma

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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

Advanced Non-squamous Non-small-cell Lung Cancer

Advanced Squamous Non-Small Cell Lung Carcinoma

Metastatic Non-squamous Non Small Cell Lung Cancer

Metastatic Squamous Non-Small Cell Lung Carcinoma

Non-small Cell Lung Cancer

Study ID

NCT06463665

Start date

Sep 26, 2024

Status verified date

Jun, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 pregnancy test prior to initiating study dosing.
  • Be willing and able to comply with scheduled visits, the treatment plan, imaging and laboratory tests.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

142 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single-arm run-in Olvi-Vec dose escalation Cohorts

Cohort 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.

experimental: Experimental Arm

Olvi-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.

active comparator: Active Comparator Arm

Docetaxel starts in Week 0 and continues until disease progression is assessed by the BICR.

other: Active Comparator Arm Cross-over

Patients 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.

Interventions

Olvimulogene nanivacirepvec

Olvi-Vec is an engineered oncolytic vaccinia virus

Platinum chemotherapy: carboplatin or cisplatin

Administered according to local practice.

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

Administered according to local practice.

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

Administered according to local practice.

Docetaxel

Administered according to local practice.

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. ]

Central Contacts and Locations

Locations

Pioneer Research Center, LLC

Recruiting

Bullhead City, Arizona, United States, 86442

Contacts

Hamdy Mohtaseb, MD

928-216-4560hmohtaseb@azcancerandblood.com

Principal Investigator:

Hamdy Mohtaseb, MD

Clermont Oncology Center

Recruiting

Clermont, Florida, United States, 34711

Contacts

Kiran Penta

386-538-3169kiran@aorcorp.com

Principal Investigator:

Gopal Kunta, MD

Oncology & Hematology Associates of West Broward

Recruiting

Coral Springs, Florida, United States, 33065

Contacts

Sumit Sawhney, MD

954-726-0035sumit@bellsouth.net

Principal Investigator:

Sumit Sawhney, MD

Helios Clinical Research

Recruiting

Fort Lauderdale, Florida, United States, 33316

Contacts

Kylee Charlemagne

645-225-9003kylee.charlemagne@heliosclinical.com

Principal Investigator:

Edgardo Santos, MD

Bioresearch Partner

Recruiting

Hialeah, Florida, United States, 33013

Contacts

Jenrrys Mejias

833-489-4968jmejias@bioresearchpartner.com

Jonathan Matias

833-489-4968jmatias@bioresearchpartner.com

Principal Investigator:

Luis Rangel, MD

University of Miami - Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Richa Dawar, MD

954-461-2107richa.dawar@med.miami.edu

Principal Investigator:

Richa Dawar, MD

Bioresearch Partner

Recruiting

Miami, Florida, United States, 33155

Contacts

Handy Del Sol Bello

833-489-4968handy@bioresearchpartner.com

Marianna Wefer

833-489-4968mwefer@bioresearchpartner.com

Principal Investigator:

Javier Perez Fernandez, MD

Mid Florida Hematology and Oncology Center

Recruiting

Orange City, Florida, United States, 32763

Contacts

Kiran Penta

386-538-3169kiran@aorcorp.com

Principal Investigator:

Santosh Nair, MD

BRCR Medical Center, Inc.

Recruiting

Plantation, Florida, United States, 33322

Contacts

Anamaria Astudillo

561-447-0614anamariaa@brcrglobal.com

Principal Investigator:

Harshad Amin, MD

Michigan Hematology and Oncology Consultants

Recruiting

Dearborn, Michigan, United States, 48126

Contacts

Heather Austin

585-216-7617heather.austin@profoundresearch.com

Principal Investigator:

Faisel Musa, MD

Oakland Medical Group

Recruiting

Farmington Hills, Michigan, United States, 48336

Contacts

Catherine Maples

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

Principal Investigator:

Jeffrey Margolis, MD

Inspira Medical Center Mullica Hill

Recruiting

Mullica Hill, New Jersey, United States, 08062

Contacts

Research

856-641-6989research@ihn.org

Principal Investigator:

Erev Tubb, MD

Gabrail Cancer and Research Center

Recruiting

Canton, Ohio, United States, 44718

Contacts

Carrie Smith

330-492-3345csmith@gabrailcancercenter.com

Kim Roby

330-492-3345kroby@gabrailcancercenter.com

Principal Investigator:

Nashat Gabrail, MD

Texas Oncology - Austin Central

Recruiting

Austin, Texas, United States, 78745

Contacts

Marian Heaven, BSN

512-427-9400Marian.heaven@usoncology.com

Principal Investigator:

James Uyeki, MD

World Research Link

Recruiting

Baytown, Texas, United States, 77521

Contacts

Isabel Navarrete

833-832-8328isabel.navarrete@worldresearchlink.com

Dustyn Tobin, MD

833-832-8328dr.tobin@worldresearchlink.com

Principal Investigator:

Amir Rasheed, MD

More Information

Sponsor

Genelux Corporation

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

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
  • carcinoma
  • Neoplasms by Histologic type
  • Antineoplastic Agents, Phytogenic
  • Antineoplastic Agents
  • Antimitotic Agents
  • Molecular Mechanisms of Pharmacological Action
  • Immune Checkpoint Inhibitors
  • NSCLC
  • NSCL cancer
  • chemoimmunotherapy
  • ICI
  • platinum resensitization
  • platinum resistant
  • chemoresistance
  • resensitize
  • olvimulogene nanivacirepvec

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Genelux Corporation on 2026-06-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.