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Therapeutic cancer vaccine for patients with advanced lung cancer resistant to immunotherapy

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

Phase 3 Interventional OSE Immunotherapeutics · NCT06472245

This study is testing a new cancer vaccine called OSE2101 to see if it can help people with advanced lung cancer who haven't responded to other immunotherapy treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment363 (estimated)
Ages18 Years and up
SexAll
SponsorOSE Immunotherapeutics Industry-sponsored
Drugs / interventionsradiation
Locations207 sites (Beverly Hills, California and 206 other locations)
Trial IDNCT06472245 on ClinicalTrials.gov

What this trial studies

This phase 3 clinical trial evaluates the efficacy of OSE2101, a therapeutic cancer vaccine, in patients with non-small cell lung cancer (NSCLC) who have developed secondary resistance to immune checkpoint inhibitors. The study is multicenter and randomized, with participants assigned to either receive OSE2101 monotherapy or standard of care treatment with docetaxel. Patients will be stratified based on their tumor histology and performance status to ensure balanced groups. The trial aims to assess the potential of OSE2101 to improve outcomes in this challenging patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with HLA-A2 positive metastatic NSCLC who have shown secondary resistance to immune checkpoint inhibitors.

Not a fit: Patients with EGFR, ALK, or ROS1 gene alterations that are eligible for targeted therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced lung cancer who have limited treatment choices due to resistance to existing therapies.

How similar studies have performed: While this approach is innovative, similar studies exploring cancer vaccines in resistant NSCLC have shown promise, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female, aged ≥ 18 years
2. Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory
3. Patients with histologically or cytologically squamous or non-squamous documented NSCLC, metastatic stage at study entry, not eligible for definite surgery or radiation, without EGFR, ALK and ROS1 gene alterations eligible for targeted therapy; for patients with squamous NSCLC, the molecular tests are not mandatory if age ≥ 50 years old and smoker ≥ 15 pack years; other sensitizing mutations known to be immunosensitive are eligible in case of lack of local access to targeted therapy (i.e.; KRAS G12C and BRAF mutations) after Sponsor' agreement.
4. Patients with secondary resistance to ICI;

Other inclusion and exclusion criteria will apply per protocol.

Where this trial is running

Beverly Hills, California and 206 other locations

+157 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Patients With Non-Small Cell Lung CancerImmune Checkpoint InhibitorCancer vaccineNon-Small Cell Lung Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.