Phase 2 Lung Cancer Trial, Recruiting NCT06463665 Sponsor: Genelux Corporation Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT06463665
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older, of any gender.
  • People whose cancer has not significantly affected their ability to carry out daily activities (a doctor would assess this using a standard scale called ECOG, with a score of 0 or 1).
  • People who have been confirmed through a tissue or cell sample to have advanced or metastatic non-small cell lung cancer (NSCLC) that has spread or cannot be removed.
  • People whose lung cancer has been confirmed as Stage III or IV (either squamous or non-squamous type, based on standard staging guidelines).
  • People who have already received at least 2 but no more than 6 cycles of a standard first-line chemotherapy combination (platinum-based chemotherapy plus an immune checkpoint inhibitor), regardless of a particular protein marker (PD-L1) level.
  • People whose cancer was first confirmed to have grown or spread (by a scan) while they were still receiving their first-line or maintenance immune checkpoint inhibitor treatment.
  • People who have at least one measurable tumour (outside the brain) that can be detected on a CT or MRI scan, meeting specific size criteria.
  • People whose kidneys, liver, bone marrow, blood clotting, and immune system are all functioning at an adequate level, as confirmed by blood tests.
  • Women who could potentially become pregnant must have a negative blood pregnancy test before starting the study treatment.
  • People who are willing and able to attend all scheduled visits, follow the treatment plan, and complete required scans and blood tests.

Who may not be able to join:

  • People with an active urinary tract infection, pneumonia, or other ongoing systemic infection that has not been treated.
  • People who currently have symptoms caused by cancer that has spread to the brain or central nervous system.
  • People with any uncontrolled medical condition or illness that, in the doctor's opinion, could interfere with how the study treatment is assessed or affect patient safety.
  • People who still have significant side effects (rated Grade 3 or higher on a standard medical scale) from previous cancer treatment — noting that hair loss and a skin condition called vitiligo are exceptions to this rule.
  • People who needed immune-suppressing medications (other than low-dose steroids) to manage a side effect from prior treatment, or who are currently taking more than 10 mg per day of prednisone (or an equivalent steroid dose).
  • People who are currently taking certain antiviral medications known to be active against vaccinia virus (such as cidofovir, vaccinia immunoglobulin, imatinib, or tecovirimat).
  • People who have had major surgery within the 4 weeks before the planned start of treatment, or who have not sufficiently recovered from a previous surgery.
  • People who have previously received a virus-based gene therapy or any treatment using a virus designed to destroy cells.
  • People who have received a smallpox or monkeypox vaccination within the past year.
  • People who have received any non-cancer vaccine (such as a flu shot or COVID-19 vaccine) within the 2 weeks before the planned first dose of study treatment.
  • People with a significant skin condition, such as severe eczema, psoriasis, or an unhealed skin wound or ulcer, as assessed by the doctor.
  • People with a known allergy or sensitivity to carboplatin, cisplatin, paclitaxel, nab-paclitaxel, docetaxel, or gentamicin (an ingredient in the study drug Olvi-Vec).
  • People who have previously had a severe allergic reaction (Grade 3 or higher) to an immune checkpoint inhibitor or its ingredients.
  • People with dementia, significantly altered mental state, or psychiatric or personal circumstances that could prevent them from giving informed consent or following the study requirements.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Genelux Corporation
Registry
ClinicalTrials.gov
Start date
26 September 2024
Est. completion
1 February 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Progression-free Survival per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Central Review (BICR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov