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

NCT06463665 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2025-09-26

No results posted yet for this study

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.

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

Olvi-Vec is an engineered oncolytic vaccinia virus

DRUG

Platinum chemotherapy: carboplatin or cisplatin

Administered according to local practice.

DRUG

Non-platinum chemotherapy: paclitaxel or nab-paclitaxel for squamous cell NSCLC or pemetrexed for nonsquamous cell NSCLC

Administered according to local practice.

DRUG

Physician's Choice of Immune Checkpoint Inhibitor: pembrolizumab, nivolumab, cemiplimab, atezolizumab, durvalumab

Administered according to local practice.

DRUG

Docetaxel

Administered according to local practice.

Sponsors & Collaborators

  • Newsoara Biopharma Co., Ltd.

    collaborator INDUSTRY

  • Genelux Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-26
Primary Completion
2027-02-28
Completion
2029-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06463665 on ClinicalTrials.gov