Health Trials

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

ConditionsAdvanced Non-squamous Non-small-cell Lung CancerAdvanced Squamous Non-Small Cell Lung CarcinomaMetastatic Non-squamous Non Small Cell Lung CancerMetastatic Squamous Non-Small Cell Lung CarcinomaNon-small Cell Lung CancerNon-small Cell Lung Cancer Stage IIINon-small Cell Lung Cancer Stage IVNon-small Cell Lung Cancer Recurrent
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenelux Corporation

About this trial

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 criteria

Qualifiers

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].

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Olvimulogene nanivacirepvec
  • Platinum chemotherapy: carboplatin or cisplatin
  • Non-platinum chemotherapy: paclitaxel or nab-paclitaxel for squamous cell NSCLC or pemetrexed for nonsquamous cell NSCLC
  • Physician's Choice of Immune Checkpoint Inhibitor: pembrolizumab, nivolumab, cemiplimab, atezolizumab, durvalumab
  • Docetaxel

Treatment groups

142 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Genelux Corporation

Lead sponsor

Newsoara Biopharma Co., Ltd.

Collaborator

Source ClinicalTrials.gov