Phase 2 Rare Disease Trial, Recruiting NCT05751798 Sponsor: OSE Immunotherapeutics Condition: Rare Disease
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Phase 2 Rare Disease Trial, Recruiting

NCT05751798
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years of age or older
  • You are willing to sign a consent form before any trial-related procedures begin
  • You are generally active and able to carry out daily activities with little to no limitation (confirm with trial site what this means for your situation)
  • You are covered by a social security or health insurance system, where required in your country
  • A blood test shows your immune system carries a specific protein marker called HLA-A2 (some patients without this marker may also be included in one part of the trial)
  • You have been diagnosed with advanced (Stage IV) lung cancer that has spread and cannot be removed by surgery or fully treated with radiation, your tumor has a specific protein called PD-L1 on at least 50% of cells, and your cancer does not have certain gene changes that would make you eligible for other targeted treatments
  • You have not yet received any systemic treatment (such as chemotherapy or immunotherapy) for your advanced cancer — if you had earlier treatment before or after surgery, it must have finished at least 6 months before your cancer was found to have spread
  • You have at least one measurable tumour that can be tracked on scans
  • Your blood, kidney, and liver test results are within acceptable ranges to safely take part (confirm exact values with trial site)

Who may not be able to join:

  • Your cancer could be treated with surgery or another approved treatment known to be beneficial, or you have a known allergy to any ingredients in the trial drugs (OSE2101 or docetaxel)
  • You have previously been treated with certain immunotherapy drugs that target PD-1 or PD-L1 (approved or experimental)
  • You have an active autoimmune disease, or a history of one that required treatment with steroids or immune-suppressing medications (some exceptions may apply — confirm with trial site)
  • You are currently taking part in another clinical trial involving a medication
  • You are still experiencing side effects from a previous cancer treatment that have not fully resolved, with some exceptions such as mild nerve-related symptoms or hair loss (confirm with trial site)
  • You have another cancer that is currently active or needs treatment — though certain common skin cancers and early-stage cervical cancer do not disqualify you
  • You have active brain metastases (cancer that has spread to the brain) or cancer affecting the membranes around the brain — though previously treated and stable brain metastases may be acceptable under specific conditions (confirm with trial site)
  • You have active or past inflammation of the lungs (non-infectious pneumonitis) that required steroid treatment, or you have a chronic lung scarring condition
  • You have any other medical condition, treatment, or lab result that could interfere with the trial or your ability to participate safely (confirm with trial site)
  • You have had a serious heart-related problem — such as a stroke, heart attack, chest pain, dangerous heart rhythm, significant heart failure, or heart muscle inflammation — within the 6 months before starting the trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +33 631 654 710

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
OSE Immunotherapeutics
Registry
ClinicalTrials.gov
Start date
20 December 2022
Est. completion
1 December 2029

Where this trial is recruiting

🇧🇪 Belgium 🇫🇷 France 🇪🇸 Spain

Primary endpoints

Part A: Occurrence of dose limiting toxicity (DLT). Part B: Safety and tolerability of the combination OSE-279/OSE2101. Part C: Overall response rate (ORR) of the combination OSE-279/OSE2101

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov