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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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 sites (15)
AZ
- Pioneer Research Center, LLC · Bullhead City, AZ 86442Hamdy Mohtaseb, MD · Study contact · 928-216-4560 · hmohtaseb@azcancerandblood.comHamdy Mohtaseb, MD · Principal investigatorMore trials in Bullhead City
FL
- Clermont Oncology Center · Clermont, FL 34711Kiran Penta · Study contact · 386-538-3169 · kiran@aorcorp.comGopal Kunta, MD · Principal investigatorMore trials in Clermont
- Oncology & Hematology Associates of West Broward · Coral Springs, FL 33065Sumit Sawhney, MD · Study contact · 954-726-0035 · sumit@bellsouth.netSumit Sawhney, MD · Principal investigatorMore trials in Coral Springs
- Helios Clinical Research · Fort Lauderdale, FL 33316Kylee Charlemagne · Study contact · 645-225-9003 · kylee.charlemagne@heliosclinical.comEdgardo Santos, MD · Principal investigatorMore trials in Fort Lauderdale
- Bioresearch Partner · Hialeah, FL 33013Jenrrys Mejias · Study contact · 833-489-4968 · jmejias@bioresearchpartner.comJonathan Matias · Study contact · 833-489-4968 · jmatias@bioresearchpartner.comLuis Rangel, MD · Principal investigatorMore trials in Hialeah
- University of Miami - Sylvester Comprehensive Cancer Center · Miami, FL 33136Richa Dawar, MD · Study contact · 954-461-2107 · richa.dawar@med.miami.eduRicha Dawar, MD · Principal investigatorMore trials in Miami
- Bioresearch Partner · Miami, FL 33155Handy Del Sol Bello · Study contact · 833-489-4968 · handy@bioresearchpartner.comMarianna Wefer · Study contact · 833-489-4968 · mwefer@bioresearchpartner.comJavier Perez Fernandez, MD · Principal investigatorMore trials in Miami
- Mid Florida Hematology and Oncology Center · Orange City, FL 32763Kiran Penta · Study contact · 386-538-3169 · kiran@aorcorp.comSantosh Nair, MD · Principal investigatorMore trials in Orange City
- BRCR Medical Center, Inc. · Plantation, FL 33322Anamaria Astudillo · Study contact · 561-447-0614 · anamariaa@brcrglobal.comHarshad Amin, MD · Principal investigatorMore trials in Plantation
MI
- Michigan Hematology and Oncology Consultants · Dearborn, MI 48126Heather Austin · Study contact · 585-216-7617 · heather.austin@profoundresearch.comFaisel Musa, MD · Principal investigatorMore trials in Dearborn
- Oakland Medical Group · Farmington Hills, MI 48336Catherine Maples · Study contact · 517-375-3057 · Catherine.Maples@profoundresearch.comJeffrey Margolis, MD · Principal investigatorMore trials in Farmington Hills
NJ
- Inspira Medical Center Mullica Hill · Mullica Hill, NJ 08062Research · Study contact · 856-641-6989 · research@ihn.orgErev Tubb, MD · Principal investigatorMore trials in Mullica Hill
OH
- Gabrail Cancer and Research Center · Canton, OH 44718Carrie Smith · Study contact · 330-492-3345 ext. 208 · csmith@gabrailcancercenter.comKim Roby · Study contact · 330-492-3345 ext. 227 · kroby@gabrailcancercenter.comNashat Gabrail, MD · Principal investigatorMore trials in Canton
TX
- Texas Oncology - Austin Central · Austin, TX 78745Marian Heaven, BSN · Study contact · 512-427-9400 · Marian.heaven@usoncology.comJames Uyeki, MD · Principal investigatorMore trials in Austin
- World Research Link · Baytown, TX 77521Isabel Navarrete · Study contact · 833-832-8328 · isabel.navarrete@worldresearchlink.comDustyn Tobin, MD · Study contact · 833-832-8328 · dr.tobin@worldresearchlink.comAmir Rasheed, MD · Principal investigatorMore trials in Baytown