Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
Launched by OSE IMMUNOTHERAPEUTICS · Jun 21, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new cancer vaccine called OSE2101 for patients with non-small cell lung cancer (NSCLC) who have not responded well to previous treatments with immune checkpoint inhibitors (ICIs). The trial is designed for patients with advanced stages of NSCLC who are not eligible for surgery or radiation therapy. Participants will be randomly assigned to receive either the experimental vaccine alone or standard treatment with a drug called docetaxel. The goal is to see if the vaccine can help improve outcomes for these patients.
To be eligible for the trial, participants must be at least 18 years old, have a specific type of immune marker in their blood, and have confirmed NSCLC that is not responding to previous treatments. Both men and women can participate. During the trial, patients will be closely monitored for their health and any side effects. This study is currently recruiting participants, and it aims to gather important information that could help improve treatment options for people with this challenging condition.
Gender
ALL
Eligibility 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; 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's agreement
- • 4. Patients with secondary resistance to ICI;
- • Other inclusion and exclusion criteria will apply per protocol.
About Ose Immunotherapeutics
Ose Immunotherapeutics is a biopharmaceutical company focused on developing innovative immunotherapies for the treatment of cancer and autoimmune diseases. With a robust pipeline of proprietary products, Ose leverages its expertise in immune modulation to create targeted therapies that enhance the body's natural defenses against disease. Committed to advancing scientific research and improving patient outcomes, the company collaborates with leading academic institutions and industry partners to accelerate the development of its therapeutic candidates. Ose Immunotherapeutics is dedicated to delivering transformative solutions in immunotherapy, aiming to address unmet medical needs and improve the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Worcester, Massachusetts, United States
Madrid, , Spain
Baton Rouge, Louisiana, United States
Norwich, Connecticut, United States
Barcelona, , Spain
Berlin, , Germany
Madrid, , Spain
Madrid, , Spain
A Coruña, , Spain
Lugo, , Spain
Córdoba, , Spain
Groningen, , Netherlands
Montpellier, , France
Sevilla, , Spain
Badalona, Barcelona, Spain
Orbassano, Torino, Italy
Bonn, Nordrhein Westfalen, Germany
Paris, , France
Marseille Cedex 9, , France
Barcelona, , Spain
Bayonne, , France
Paris, , France
Aachen, Nordrhein Westfalen, Germany
Pisa, , Italy
Lake Success, New York, United States
Chicago, Illinois, United States
Rome, , Italy
Lyon, , France
Marseille, , France
Washington, District Of Columbia, United States
Barcelona, , Spain
Girona, , Spain
Le Mans, , France
Gauting, Bayern, Germany
Essen, Nordrhein Westfalen, Germany
A Coruña, La Coruña, Spain
Saint Augustine, Florida, United States
Kassel, Hessen, Germany
Nijmegen, Gelderland, Netherlands
łódź, , Poland
Jacksonville Beach, Florida, United States
Montréal, Quebec, Canada
Majadahonda, Madrid, Spain
Cluj Napoca, Cluj, Romania
Paris, Ile De France, France
La Tronche, , France
Manchester, England, United Kingdom
Jacksonville, Florida, United States
Hasselt, Limburg, Belgium
Aberdeen, Scotland, United Kingdom
Palma De Mallorca, Balearic Islands, Spain
Las Palmas De Gran Canaria, Las Palmas, Spain
Milan, , Italy
Saint Petersburg, Florida, United States
Leuven, Flemish Brabant, Belgium
Sutton, England, United Kingdom
Brasschaat, Antwerpen, Belgium
Strasbourg Cedex, Alsace, France
Montpellier, Hérault, France
Bayonne, Pyrénées Atlantiques, France
Rimouski, Quebec, Canada
Covington, Louisiana, United States
Gent, Oost Vlaaderen, Belgium
Rotterdam, Zuid Holland, Netherlands
Heraklion, Crete, Greece
Novara, , Italy
Grosshansdorf, Schleswig Holstein, Germany
Patra, Peloponnese, Greece
Roeselare, West Vlaanderen, Belgium
Paris, île De France, France
Poitiers, Vienne, France
Greenville, South Carolina, United States
Athens, Attica, Greece
Villejuif, Val De Marne, France
Porto, , Portugal
Meldola, , Italy
Siena, , Italy
Rozzano, Milan, Italy
Budapest, , Hungary
Milan, , Italy
Nashville, Tennessee, United States
Marseille, Provence Alpes Cote D´Azur, France
Genova, , Italy
Barcelona, , Spain
Wirral, England, United Kingdom
Meldola, Forlì Cesena, Italy
Toulouse Cedex 9, Midi Pyrenees, France
Créteil, Ile De France, France
Halle, Sachsen Anhalt, Germany
Nantes, , France
Roma, , Italy
Mulhouse, Grand Est, France
Lincoln, Nebraska, United States
Lecce, , Italy
Merriam, Kansas, United States
Brewster, New York, United States
Fishkill, New York, United States
Lake Success, New York, United States
Mount Kisco, New York, United States
Poughkeepsie, New York, United States
Richmond Hill, New York, United States
Port Jefferson Station, New York, United States
Tacoma, Washington, United States
Babylon, New York, United States
Bronx, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
Patchogue, New York, United States
Port Jefferson Station, New York, United States
Riverhead, New York, United States
Shirley, New York, United States
Namur, Wallonia, Belgium
Kortrijk, West Vlaanderen, Belgium
Toulon Cedex 9, Alpes De Haute Provence, France
Marseille Cedex 9, Bouches Du Rhône, France
Besançon Cedex, Doubs, France
Brest, Finistère, France
Limoges, Haute Vienne, France
Bobigny, Ile De France, France
Rennes Cedex 9, Ille Et Vilaine, France
Saint Herblain, Loire Atlantique, France
Cholet, Maine Et Loire, France
La Tronche, Rhône, France
La Roche Sur Yon, , France
Lisboa, , Portugal
Craiova, Dolj, Romania
Barakaldo, Biscay, Spain
Marbella, Malaga, Spain
Málaga, , Spain
Athens, Attica, Greece
Bradenton, Florida, United States
Brandon, Florida, United States
Fleming Island, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Largo, Florida, United States
Neptune Beach, Florida, United States
Palm Harbor, Florida, United States
Saint Petersburg, Florida, United States
Trinity, Florida, United States
Hammond, Louisiana, United States
Lincoln, Nebraska, United States
Brewster, New York, United States
Brooklyn, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
Chattanooga, Tennessee, United States
Chattanooga, Tennessee, United States
Chattanooga, Tennessee, United States
Chattanooga, Tennessee, United States
Cleveland, Tennessee, United States
Cookeville, Tennessee, United States
Dickson, Tennessee, United States
Franklin, Tennessee, United States
Gallatin, Tennessee, United States
Hendersonville, Tennessee, United States
Hermitage, Tennessee, United States
Lebanon, Tennessee, United States
Murfreesboro, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Shelbyville, Tennessee, United States
Smyrna, Tennessee, United States
Roeselare, West Vlaanderen, Belgium
Roeselare, West Vlaanderen, Belgium
Lyon, Rhone Alpes, France
Athens, Attica, Greece
Néa Kifisiá, Attica, Greece
Thessaloniki, Central Macedonia, Greece
Thessaloniki, Macedoni, Greece
Thessaloníki, Thessaloniki, Greece
Larissa, Thessaly, Greece
San Filippo, Lucca, Italy
Rimini, , Italy
łódź, Lódzkie, Poland
Gdańsk, Pomorskie, Poland
Lisboa, , Portugal
Timisoara, Timis, Romania
Gyöngyös, Heves, Hungary
Gyöngyös, , Hungary
Bydgoszcz, Kujawsko Pomorskie, Poland
Lublin, Lubelskie, Poland
Konin, Wielkopolskie, Poland
Beverly Hills, California, United States
Encino, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Littleton, Colorado, United States
Wheat Ridge, Colorado, United States
Baltimore, Maryland, United States
Bronx, New York, United States
Perrysburg, Ohio, United States
Toledo, Ohio, United States
Bonney Lake, Washington, United States
Federal Way, Washington, United States
Gig Harbor, Washington, United States
Puyallup, Washington, United States
Chicoutimi, Quebec, Canada
Bron, Rhone Alpes, France
Avignon, Vaucluse, France
Paris, île De France, France
Stuttgart, Bade Wurtemberg, Germany
Heidelberg, Baden Wuerttemberg, Germany
München, Bayern, Germany
Homburg, Saarland, Germany
Piraeus, Athens, Greece
Napoli, Naples, Italy
Legnago, Verona, Italy
Padova, , Italy
Poznan, Wielkopolskie, Poland
Coimbra, , Portugal
Vila Nova De Gaia, , Portugal
L'hospitalet De Llobregat, Barcelona, Spain
Leicester, England, United Kingdom
Brest, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported