Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer
← catalyst calendarNCT06463665 · readout ≤ 193 d
Sponsored by Genelux Corporation (industry) · GNLX — their whole pipeline →. With Newsoara Biopharma Co., Ltd..
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
142estimated
Sites
15
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-09-26 | actual | When the study began enrolling |
| Primary completion | Feb 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2024-06-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
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 — also filed as Olvi-Vec, GL-ONC, GLV-1h68
- Drug: Platinum chemotherapy: carboplatin or cisplatin — also filed as Brand of drug is based on institutional procurement
- Drug: Non-platinum chemotherapy: paclitaxel or nab-paclitaxel for squamous cell NSCLC or pemetrexed for nonsquamous cell NSCLC — also filed as Brand of drug is based on institutional procurement
- Drug: Physician's Choice of Immune Checkpoint Inhibitor: pembrolizumab, nivolumab, cemiplimab, atezolizumab, durvalumab — also filed as Brand of drug is based on institutional procurement
- Drug: Docetaxel — also filed as Brand of drug is based on institutional procurement
Primary outcome
what the primary-completion date above is the date OFProgression-free Survival per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Central Review (BICR)
measured From date of randomization up to 12 months.
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