Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
- Conditions
- Patients With Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT06472245
- Lead Sponsor
- OSE Immunotherapeutics
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 363
- Male or female, aged ≥ 18 years
- Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory
- 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
- Patients with secondary resistance to ICI;
Other inclusion and exclusion criteria will apply per protocol.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: OSE2101 NGS HLAA2 assay Unit dose: 1 mL corresponding to a total of 5 mg of the combination of peptides Mode/Route: Subcutaneous injection Regimen: One injection every three weeks for six cycles, then every eight weeks for the remainder of year one and, finally every twelve weeks until the end of second year. Arm B: Docetaxel NGS HLAA2 assay Unit dose: 75 mg/m2 Mode/Route: Intravenous infusion over 1 hour Regimen: One infusion every three weeks. Arm A: OSE2101 OSE2101 Unit dose: 1 mL corresponding to a total of 5 mg of the combination of peptides Mode/Route: Subcutaneous injection Regimen: One injection every three weeks for six cycles, then every eight weeks for the remainder of year one and, finally every twelve weeks until the end of second year. GenDx CDx Tedopi NGS HLAA2 assay System of qualitative companion diagnostic devices, consisting of a polymerase chain reaction (PCR) assay Amp-HLA-A-CDx Tedopi, a DNA library preparation assay, LFK-CDx Tedopi and the software NGSengine-CDx Tedopi. Arm B: Docetaxel Docetaxel Unit dose: 75 mg/m2 Mode/Route: Intravenous infusion over 1 hour Regimen: One infusion every three weeks.
- Primary Outcome Measures
Name Time Method OS defined as time from randomization to death From randomization date through study completion, an average of 3 years OS defined as time from randomization to death of any cause, censored until the data analysis cut-off date
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (55)
Centre Hospitalier Le Mans
🇫🇷Le Mans, France
Centre Hospitalier Départemental Vendée
🇫🇷La Roche-sur-Yon, France
HC Marbella
🇪🇸Marbella, Malaga, Spain
Clínica Mi Tres Torres
🇪🇸Barcelona, Spain
Hospital Universitari Dexeus
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Spain
Hospital Universitari de Girona Dr. Josep Trueta
🇪🇸Girona, Spain
Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec
🇫🇷Nantes, France
Unidade Local de Saúde de Santa Maria, E. P. E. - Hospital Pulido Valente
🇵🇹Lisboa, Portugal
Centrul de Oncologie Sf Nectarie
🇷🇴Craiova, Dolj, Romania
Biocruces Bizkaia Instituto de Investigación Sanitaria
🇪🇸Barakaldo, Biscay, Spain
Hospital Universitario Lucus Augusti
🇪🇸Lugo, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Regional Universitario de Málaga - Hospital General
🇪🇸Málaga, Spain
Hôpital Michallon
🇫🇷La Tronche, Rhône, France
New York Cancer & Blood Specialists - Babylon Medical Oncology
🇺🇸Babylon, New York, United States
New York Cancer & Blood Specialists - Eastchester Cancer Care Center
🇺🇸Bronx, New York, United States
New York Cancer & Blood Specialists - New Hyde Park
🇺🇸New Hyde Park, New York, United States
New York Cancer & Blood Specialists - Central Park Medical Oncology
🇺🇸New York, New York, United States
New York Cancer & Blood Specialists - Patchogue Medical Oncology
🇺🇸Patchogue, New York, United States
New York Cancer & Blood Specialists - Port Jefferson Station Medical Oncology
🇺🇸Port Jefferson Station, New York, United States
New York Cancer & Blood Specialists - Riverhead Medical Oncology
🇺🇸Riverhead, New York, United States
New York Cancer & Blood Specialists - Research Headquarters
🇺🇸Shirley, New York, United States
Algemeen Ziekenhuis Klina
🇧🇪Brasschaat, Antwerpen, Belgium
Algemeen Ziekenhuis Maria Middelares
🇧🇪Gent, Oost-Vlaaderen, Belgium
Centre Hospitalier Universitaire Université Catholique de Louvain Namur - Site Sainte-Elisabeth
🇧🇪Namur, Wallonia, Belgium
Algemeen Ziekenhuis Groeninge - Campus Kennedylaan
🇧🇪Kortrijk, West-Vlaanderen, Belgium
Hôpital d'Instruction des Armées Sainte-Anne
🇫🇷Toulon Cedex 9, Alpes-de-Haute-Provence, France
Nouvel Hôpital Civil
🇫🇷Strasbourg cedex, Alsace, France
Institut Paoli-Calmettes
🇫🇷Marseille cedex 9, Bouches-du-Rhône, France
Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz
🇫🇷Besançon Cedex, Doubs, France
Centre Hospitalier Regional Universitaire Brest - Hopital de la Cavale Blanche
🇫🇷Brest, Finistère, France
Hôpital Emile Muller
🇫🇷Mulhouse, Grand Est, France
Centre Hospitalier Universitaire Dupuytren 1
🇫🇷Limoges, Haute-Vienne, France
Hôpital Arnaud de Villeneuve
🇫🇷Montpellier, Hérault, France
Hôpital Avicenne
🇫🇷Bobigny, Ile-de-France, France
Centre Hospitalier Intercommunal de Créteil
🇫🇷Créteil, Ile-De-France, France
Hôpital Pontchaillou
🇫🇷Rennes cedex 9, Ille-et-Vilaine, France
Institut de Cancérologie de l'Ouest - Saint-Herblain - Site René Gauducheau
🇫🇷Saint-Herblain, Loire-Atlantique, France
Centre Hospitalier (Ch) De Cholet
🇫🇷Cholet, Maine-et-Loire, France
Hôpital Larrey
🇫🇷Toulouse cedex 9, Midi-pyrenees, France
Centre Hospitalier de la Côte Basque
🇫🇷Bayonne, Pyrénées-Atlantiques, France
The Christie NHS Foundation Trust
🇬🇧Manchester, England, United Kingdom
The Royal Marsden NHS Foundation Trust
🇬🇧Sutton, England, United Kingdom
Georgetown Lombardi Comprehensive Cancer Center
🇺🇸Washington, District of Columbia, United States
Alliance for Multispecialty Research (AMR) - Kansas City Oncology
🇺🇸Merriam, Kansas, United States
NHO Revive Research Institute LLC
🇺🇸Lincoln, Nebraska, United States
Optum Medical Care - Carmel/Brewster Campus
🇺🇸Brewster, New York, United States
Optum Medical Care - Fishkill Westage Campus
🇺🇸Fishkill, New York, United States
Optum Hematology Oncology - Lake Success
🇺🇸Lake Success, New York, United States
Optum Medical Care - Mount Kisco Campus 90
🇺🇸Mount Kisco, New York, United States
Optum Medical Care - Poughkeepsie
🇺🇸Poughkeepsie, New York, United States
Brooklyn Radiation Oncology
🇺🇸Richmond Hill, New York, United States
Bon Secours Hematology and Oncology
🇺🇸Greenville, South Carolina, United States