drugset / Trial / NCT06463665
Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2024-09-26
- Primary completion
- 2027-02
- Completion
- 2029-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | — | — |
| Subject | Carboplatin | Small molecule | — | — |
| Subject | Cemiplimab | Monoclonal antibody | — | — |
| Subject | Cisplatin | Other / unclassified | — | — |
| Subject | Docetaxel | Small molecule | — | — |
| Subject | Durvalumab | Monoclonal antibody | — | — |
| Subject | Nivolumab | Monoclonal antibody | — | — |
| Subject | Olvimulogene nanivacirepvec | Other / unclassified | 0.5 unknown | Intravenous |
| Subject | Olvimulogene nanivacirepvec | Other / unclassified | 1 unknown | Intravenous |
| Subject | Olvimulogene nanivacirepvec | Other / unclassified | 3 unknown | Intravenous |
| Subject | Paclitaxel | Small molecule | — | — |
| Subject | Pembrolizumab | Monoclonal antibody | — | — |
| Subject | Pemetrexed | Small molecule | — | — |