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Compares treatment options for Advanced Non-squamous Non-small-cell Lung Cancer
Official title Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer
ClinicalTrials.gov ID: NCT06463665
What this study is testing
What is Olvimulogene nanivacirepvec?
Olvimulogene nanivacirepvec is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced non-squamous non-small-cell lung cancer.
Also referred to as Olvi-Vec, GL-ONC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- Persistent toxicities [Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 3] caused by previous anticancer therapy; alopecia and vitiligo...
- Required the use of additional immunosuppression other than corticosteroids for the management of an adverse event or have experienced recurrence of...
- Receiving concurrent antiviral agent active against vaccinia virus (e.g., cidofovir, vaccinia immunoglobulin, imatinib, tecovirimat, or other agents...
See the full eligibility 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bullhead City, Arizona, United States
- Clermont, Florida, United States
- Coral Springs, Florida, United States
- Fort Lauderdale, Florida, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- Orange City, Florida, United States
- Plantation, Florida, United States
- Dearborn, Michigan, United States
- Farmington Hills, Michigan, United States
- Mullica Hill, New Jersey, United States
- Canton, Ohio, United States
- Austin, Texas, United States
- Baytown, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bullhead City, Arizona, United States; Clermont, Florida, United States; Coral Springs, Florida, United States; Fort Lauderdale, Florida, United States; Hialeah, Florida, United States; Miami, Florida, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.