Ignite Creation Date:
2024-07-17 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463665
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-11
Brief Title:
Efficacy Safety of Olvimulogene Nanivacirepvec Platinum-doublet Physicians Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer
Sponsor:
Genelux Corporation
Organization:
Genelux Corporation
Study Overview
Official Title:
A Randomized Phase 2 Study Assessing the Efficacy and Safety of Olvimulogene Nanivacirepvec Followed by Platinum-doublet Chemotherapy Physicians 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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIRO-25
Brief 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 Physicians Choice of Immune Checkpoint Inhibitor ICI vs docetaxel for patients with advanced or metastatic NSCLC who have shown first disease progression ie 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
Detailed Description:
Olvi-Vec olvimulogene nanivacirepvec aka GL-ONC1 laboratory name GLV-1h68 is an oncolytic vaccinia virus-based immunotherapy that has been shown to have broad infectivity in a wide range of tumor types including non-small-cell lung cancer NSCLC In preclinical studies Olvi-Vec was shown to infect and kill NSCLC cells and tumors in vitro and in vivo respectively and resolved and prevented formation of malignant effusion This study is to test the hypothesis that the combination of Olvi-Vec followed by further platinum-based chemotherapy plus an ICI is particularly effective against established tumors by virus-mediated immune activation and re-sensitization of tumor cells to chemotherapy Participants will have advanced or metastatic NSCLC Stage III or Stage IV squamous or nonsquamous disease without known targetable alterations in Epidermal Growth Factor Receptor EGFR Anaplastic Lymphoma Kinase ALK or Repressor of Silencing 1 ROS1 Eligible patients will have first disease progression by radiological assessment i while on front-line platinum-doublet chemotherapy and ICI or ii while receiving front-line maintenance ICI-based therapy after completion of front-line therapy with at least 2 cycles and maximum of 6 cycles of platinum-doublet chemotherapy and ICI regardless of Programmed death-ligand 1 PD-L1 expression as the first treatment after being diagnosed ICI includes anti-programmed death-1 anti-PD-1 or anti-PD-L1 agents Other classes of ICI eg anti-cytotoxic T-lymphocyte antigen 4 anti-CTLA-4 etc are excluded Patients will be stratified based on length of time on ICI-based therapy from start date of the first dose if ICI during front-line therapy until date of first progression by radiological assessment is either less than or equal to 4 months or greater than 4 months Patients enrolled in one of the initial 3 cohorts will receive either 3 or 4 days of Olvi-Vec followed by platinum-doublet chemotherapy Physicians Choice of ICI The randomization part of the study will start afterwards with the Olvi-Vec dose and schedule selected from one of the 3 cohorts for the Experimental Arm The Active Comparator Arm ACA treatment includes docetaxel Participants treated in the ACA who subsequently have documented disease progression may cross-over for treatment as per the Experimental Arm following determination of eligibility
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None