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Cancer-Fighting virus plus chemo and immunotherapy takes on lung cancer in new trial

NCT ID NCT06463665

Disease control Sponsor: Genelux Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new approach for people with advanced lung cancer whose disease got worse after initial treatment. It combines an injected virus (Olvi-Vec) that targets cancer cells, followed by chemotherapy and an immunotherapy drug, and compares it to standard chemotherapy alone. The goal is to see if the combination helps control the cancer longer. About 142 adults with non-small-cell lung cancer will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 142 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

carcinoma neoplasm Neoplasms by Histologic Type Neoplasms by Site non-small cell lung carcinoma non-small cell squamous lung carcinoma vaccinia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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 Non-small cell lung cancer (stage III) Non-small cell lung cancer recurrent Non-small cell lung cancer stage IV

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BRCR Medical Center, Inc.

    RECRUITING

    Plantation, Florida, 33322, United States

  • Bioresearch Partner

    RECRUITING

    Hialeah, Florida, 33013, United States

  • Bioresearch Partner

    RECRUITING

    Miami, Florida, 33155, United States

  • Clermont Oncology Center

    RECRUITING

    Clermont, Florida, 34711, United States

  • Gabrail Cancer and Research Center

    RECRUITING

    Canton, Ohio, 44718, United States

  • Helios Clinical Research

    RECRUITING

    Fort Lauderdale, Florida, 33316, United States

  • Inspira Medical Center Mullica Hill

    RECRUITING

    Mullica Hill, New Jersey, 08062, United States

  • Michigan Hematology and Oncology Consultants

    RECRUITING

    Dearborn, Michigan, 48126, United States

  • Mid Florida Hematology and Oncology Center

    RECRUITING

    Orange City, Florida, 32763, United States

  • Oakland Medical Group

    RECRUITING

    Farmington Hills, Michigan, 48336, United States

  • Oncology & Hematology Associates of West Broward

    RECRUITING

    Coral Springs, Florida, 33065, United States

  • Pioneer Research Center, LLC

    RECRUITING

    Bullhead City, Arizona, 86442, United States

  • Texas Oncology - Austin Central

    RECRUITING

    Austin, Texas, 78745, United States

  • University of Miami - Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • World Research Link

    RECRUITING

    Baytown, Texas, 77521, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.