OSE2101 for Non-Small Cell Lung Cancer with Resistance to Immunotherapy

This study is testing a therapeutic cancer vaccine called OSE2101 in people with non-small cell lung cancer (NSCLC) that has stopped responding to previous immunotherapy. OSE2101 is a vaccine designed to help your immune system recognize and fight cancer cells. It targets specific proteins found on cancer cells. The study will compare OSE2101 to docetaxel, a standard chemotherapy drug. To join, you must be at least 18 years old, have the HLA-A2 genetic marker (a specific immune system type), and have NSCLC that has spread and is not treatable with surgery or radiation. The main goal is to see if OSE2101 can help people live longer. Researchers will also look for specific biomarkers (like ALK, BRAF, EGFR, KRAS, ROS1) to understand how the treatments work.

Study design
This is a phase 3 study that will include 363 participants. It is randomized, meaning you will be assigned by chance to receive either OSE2101 or docetaxel.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your overall survival will be tracked from the time you are assigned to a treatment group until death, for an average of 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06472245

Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor

Recruiting
PHASE3Ages 18+InterventionalTreatment
OSE Immunotherapeutics
~363 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:OSE2101DocetaxelNGS HLAA2 assay

At a glance

Recruiting sites
153 of 207 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
OS defined as time from randomization to death
Measured over From randomization date through study completion, an average of 3 years
Patients With Non-Small Cell Lung Cancer
207 sites across 92 states
Tennessee23
Florida16
New York16
Spain12
Italy11
Washington5
Île-de-France Region5
Portugal5

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  • OS defined as time from randomization to deathFrom randomization date through study completion, an average of 3 years

    OS defined as time from randomization to death of any cause, censored until the data analysis cut-off date