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

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-doub

Trial Details

NCT ID
NCT06463665
Phase
PHASE2
Sponsor
Genelux Corporation
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • 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
Locations (sample)
  • Bullhead City, Arizona, United States|35.14778,-114.5683
  • Clermont, Florida, United States|28.54944,-81.77285
  • Coral Springs, Florida, United States|26.27119,-80.2706
  • Fort Lauderdale, Florida, United States|26.12231,-80.14338
  • Hialeah, Florida, United States|25.8576,-80.27811

Key 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 \[American Joint Committee on Cancer (AJCC) 8th edition\].

For full eligibility, visit ClinicalTrials.gov.

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