OSE Immunotherapeutics’ Phase 3 Trial: A New Hope for NSCLC Patients

DEL_OSE Immunotherapeutics ((DEL_0RAD)), OSE Immunotherapeutics ((DE:6OP)) announced an update on their ongoing clinical study.

OSE Immunotherapeutics is conducting a Phase 3 clinical trial titled A Randomised, Open-label, Phase 3 Trial Comparing the Efficacy and Safety of OSE2101 Versus Docetaxel in HLA-A2 Positive Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) With Secondary Resistance to Immune Checkpoint Inhibitor. The study aims to evaluate the effectiveness and safety of the therapeutic cancer vaccine OSE2101 in patients with NSCLC who have developed resistance to immune checkpoint inhibitors. This trial is significant as it addresses a critical need for new treatment options in this patient population.

The study is testing OSE2101, a peptidic cancer vaccine designed to target specific tumor-associated antigens, and compares it to Docetaxel, a standard chemotherapy drug. OSE2101 is administered via subcutaneous injection, while Docetaxel is given through intravenous infusion.

The trial follows a randomized, parallel assignment model with no masking, focusing on treatment as its primary purpose. Patients are allocated to either the experimental arm receiving OSE2101 or the control arm receiving Docetaxel.

The study began on December 3, 2024, with the latest update submitted on July 28, 2025. These dates are crucial as they indicate the trial’s progression and the timeliness of data collection.

This update could influence investor sentiment and stock performance for OSE Immunotherapeutics, as successful outcomes may enhance the company’s market position. The study’s progress is also relevant in the context of the competitive landscape of cancer therapies.

The study is currently recruiting, with further details available on the ClinicalTrials portal.