RecruitingPhase 2NCT06463665

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

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


Sponsor

Genelux Corporation

Enrollment

142 participants

Start Date

Sep 26, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether olvimulogene nanivacirepvec (a modified oncolytic virus that stimulates the immune system) combined with chemotherapy and an immune checkpoint inhibitor works better than docetaxel (standard chemotherapy) as a second-line treatment for advanced non-small cell lung cancer (NSCLC). **You may be eligible if...** - You are 18 or older with confirmed advanced or metastatic NSCLC (Stage III or IV) - You have already received at least 2 cycles (up to 6 cycles) of platinum-based chemotherapy combined with immunotherapy as initial treatment - Your cancer has since progressed while on or after that initial treatment - You have at least one measurable tumor outside the brain - You are in good general health (ECOG 0–1) **You may NOT be eligible if...** - You have an active urinary tract infection, pneumonia, or systemic infection - You have active or uncontrolled brain metastases - You have significant unresolved side effects (Grade ≥3) from prior cancer treatment - You require high-dose steroids or other immune suppression for managing prior treatment side effects Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALOlvimulogene nanivacirepvec

Olvi-Vec is an engineered oncolytic vaccinia virus

DRUGPlatinum chemotherapy: carboplatin or cisplatin

Administered according to local practice.

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

Administered according to local practice.

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

Administered according to local practice.

DRUGDocetaxel

Administered according to local practice.


Locations(16)

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

View Full Details on ClinicalTrials.gov

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NCT06463665


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