Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's of Choice Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer (VIRO-25)
NCT Number: NCT06463665
Acronym: (VIRO-25)
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Advanced Non-squamous Non-small-cell Lung Cancer|Advanced Squamous Non-Small Cell Lung Carcinoma|Metastatic Non-squamous Non Small Cell Lung Cancer|Metastatic Squamous Non-Small Cell Lung Carcinoma|Non-small Cell Lung Cancer|Non-small Cell Lung Cancer Stage III|Non-small Cell Lung Cancer Stage IV|Non-small Cell Lung Cancer Recurrent
Interventions: BIOLOGICAL: Olvimulogene nanivacirepvec|DRUG: Platinum chemotherapy: carboplatin or cisplatin|DRUG: Non-platinum chemotherapy: paclitaxel or nab-paclitaxel for squamous cell NSCLC or pemetrexed for nonsquamous cell NSCLC|DRUG: Physician's Choice of Immune Checkpoint Inhibitor: pembrolizumab, nivolumab, cemiplimab, atezolizumab, durvalumab|DRUG: Docetaxel
Sponsor: Genelux Corporation
Collaborators: Newsoara Biopharma Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 142
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2029-07

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.

Primary Outcome Measures: Progression-free Survival per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Central Review (BICR), To assess progression-free survival from time of randomization until first documented disease progression based on radiological assessment or death from any cause., From date of randomization up to 12 months.
Secondary Outcome Measures: Objective Response Rate (ORR) by RECIST 1.1, Ratio of the sum of complete responses (CR) \& partial responses (PR) divided by the number of participants from start of treatment to confirmation of response., From date of randomization up to 12 months.|Median Overall Survival, Time from randomization until death or study completion; assessed up to 36 months., From date of randomization up to 36 months.|Six-month Progression-free Survival Rate, Proportion of patients who remained alive and progression-free at 6 months., From date of randomization up to 6 months.|Incidence of Treatment-emergent Adverse Events, From date of first study treatment until death or study completion., Assessed up to 36 months.|Duration of Response by RECIST 1.1, Time from date of first response until the first date of progressive disease based on radiological assessment., From date of randomization up to 12 months.|Disease Control Rate (DCR), Percentage of patients who have achieved complete response, partial response or stable disease out of the total number of patients evaluated in a therapeutic intervention in clinical trials: DCR = \[CR + PR + SD (stable disease)\]/total # of patients evaluated by RECIST 1.1., From date of randomization up to 12 months.