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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Bérangère Vasseur, MD +33 676 448 160
berangere.vasseur@ose-immuno.com


Caroline Chevalier, MSc, MPH +33 630 842 002
caroline.chevalier@ose-immuno.com


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

Recruiting

Open to: ALL

Age: 18.0 - N/A

Manchester Sutton Aberdeen Leicester Metropolitan Borough of Wirral

Medical Conditions

Patients With Non-Small Cell Lung Cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2024 Dec 2027

Publications

"Besse B, Felip E, Garcia Campelo R, Cobo M, Mascaux C, Madroszyk A, Cappuzzo F, Hilgers W, Romano G, Denis F, Viteri S, Debieuvre D, Galetta D, Baldini E, Razaq M, Robinet G, Maio M, Delmonte A, Roch B, Masson P, Schuette W, Zer A, Remon J, Costantini D, Vasseur B, Dziadziuszko R, Giaccone G; ATALANTE-1 study group. Randomized open-label controlled study of cancer vaccine OSE2101 versus chemotherapy in HLA-A2-positive patients with advanced non-small-cell lung cancer with resistance to immunotherapy: ATALANTE-1. Ann Oncol. 2023 Oct;34(10):920-933. doi: 10.1016/j.annonc.2023.07.006. Epub 2023 Sep 11."; "37704166"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : 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.

Intervention Arm Group : Arm A: OSE2101;

Intervention Type : DRUG
Intervention Description : Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions.

Intervention Arm Group : Arm B: Docetaxel;

Intervention Type : DEVICE
Intervention Description : 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.

Intervention Arm Group : Arm A: OSE2101;Arm B: Docetaxel;GenDx CDx Tedopi;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Christie NHS Foundation Trust
    Manchester
    England
    M20 4BX
  • The Royal Marsden NHS Foundation Trust
    Sutton
    England
    SM2 5PT
  • NHS Grampian
    Aberdeen
    Scotland
    AB25 2ZN
  • University Hospitals of Leicester NHS Trust
    Leicester
    England
    LE2 9LX
  • The Clatterbridge Cancer Centre NHS Foundation Trust
    Metropolitan Borough of Wirral
    England
    CH63 4JY

Bérangère Vasseur, MD +33 676 448 160
berangere.vasseur@ose-immuno.com


Caroline Chevalier, MSc, MPH +33 630 842 002
caroline.chevalier@ose-immuno.com



The study is sponsored by OSE Immunotherapeutics and is in collaboration with Exystat; Genome Diagnostics (GenDx).



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Read full details for Trial ID: NCT06472245
Last updated 04 March 2026

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