Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer
NCT ID: NCT06463665
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
142 participants
INTERVENTIONAL
2024-09-26
2029-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Active Comparator Arm
Docetaxel starts in Week 0 and continues until disease progression is assessed by the BICR.
Docetaxel
Administered according to local practice.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Newsoara Biopharma Co., Ltd.
INDUSTRY
Genelux Corporation
INDUSTRY
Responsible Party
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Locations
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Pioneer Research Center, LLC
Bullhead City, Arizona, United States
Clermont Oncology Center
Clermont, Florida, United States
Oncology & Hematology Associates of West Broward
Coral Springs, Florida, United States
Helios Clinical Research
Fort Lauderdale, Florida, United States
Bioresearch Partner
Hialeah, Florida, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Bioresearch Partner
Miami, Florida, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States
BRCR Medical Center, Inc.
Plantation, Florida, United States
University of Maryland Medical Center Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Michigan Hematology and Oncology Consultants
Dearborn, Michigan, United States
Oakland Medical Group
Farmington Hills, Michigan, United States
Gabrail Cancer and Research Center
Canton, Ohio, United States
Texas Oncology - Austin Central
Austin, Texas, United States
World Research Link
Baytown, Texas, United States
Sheboygan Cancer & Blood Center
Sheboygan, Wisconsin, United States
Countries
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Facility Contacts
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Related Links
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Sponsor's website
Other Identifiers
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Olvi-Vec-NSCLC-025
Identifier Type: -
Identifier Source: org_study_id
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