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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: OSE2101 (drug), Docetaxel (drug), NGS HLAA2 assay (device)
How long the study runs: Study runs about 48 months (dates as stated)
About the drug or intervention: OSE2101 — drug: OSE2101 is a peptidic cancer vaccine composed of nine epitopes restricted to HLA-A2 phenotype targeting the tumor associated antigens of P53, HER-2, CEA, MAGE-2 and MAGE-3, and one pan-HLA DR binding epitope (PADRE), all epitopes emulsified in Montanide ISA 51TM adjuvant. · Docetaxel — drug: Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. · NGS HLAA2 assay — device: Amp-HLA-A-CDx Tedopi for amplification of human genomic DNA (gDNA), LFK-CDx Tedopi kit (library full kit) for library preparation, NGSengine-CDx Tedopi software for analysis of NGS data files.
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years and over
Who: All
Number of participants: 363
Started: 2024-12-03
Last checked: 2026-10

Plain English Summary

What is this study?

• Testing a new treatment for patients with non-small cell lung cancer
• Phase3 - 363 participants
• Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance

Who can take part?

• Ages 18 Years and over
• Diagnosed with patients with non-small cell lung cancer

Where?

• Leicester - University Hospitals of Leicester NHS Trust
• Manchester - The Christie NHS Foundation Trust
• Metropolitan Borough of Wirral - The Clatterbridge Cancer Centre NHS Foundation Trust
• Sutton - The Royal Marsden NHS Foundation Trust
• +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance. Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1).

Patients With Non-Small Cell Lung Cancer

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

Biomarkers mentioned

EGFRALKROS1KRASBRAF

What the study is looking for

✓Male or female, aged ≥ 18 years
✓Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory
✓Patients with secondary resistance to ICI;
✓Other inclusion and exclusion criteria will apply per protocol.

See the full 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.