Informations générales (source: ClinicalTrials.gov)
A Randomised, Open-label, Phase 3 Trial Comparing the Efficacy and Safety of OSE2101 Versus Docetaxel in HLA-A2 Positive Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) With Secondary Resistance to Immune Checkpoint Inhibitor (ARTEMIA)
Interventional
Phase 3
OSE Immunotherapeutics (Voir sur ClinicalTrials)
décembre 2024
décembre 2028
05 avril 2025
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).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Avicenne | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| CHI DE CRETEIL | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier (Ch) De Cholet - 49325 - Cholet - Maine-et-Loire - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de la Côte Basque - 64109 - Bayonne - Pyrénées-Atlantiques - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Départemental Vendée - 85000 - La Roche-sur-Yon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Le Mans - 72037 - Le Mans - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Lyon-Sud - 69317 - Lyon - Rhone-alpes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz - 25030 - Besançon Cedex - Doubs - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Regional Universitaire Brest - Hopital de la Cavale Blanche - 29200 - Brest - Finistère - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec - 44093 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Poitiers - 86021 - Poitiers - Vienne - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Dupuytren 1 - 87000 - Limoges - Haute-Vienne - France | Contact (sur clinicalTrials) | ||||
| Hôpital Arnaud de Villeneuve - 34295 - Montpellier - Hérault - France | Contact (sur clinicalTrials) | ||||
| Hôpital d'Instruction des Armées Sainte-Anne - 83800 - Toulon Cedex 9 - Alpes-de-Haute-Provence - France | Contact (sur clinicalTrials) | ||||
| Hôpital Emile Muller - 68100 - Mulhouse - Grand Est - France | Contact (sur clinicalTrials) | ||||
| Hôpital Larrey - 31059 - Toulouse cedex 9 - Midi-pyrenees - France | Contact (sur clinicalTrials) | ||||
| Hôpital Michallon - 38700 - La Tronche - Rhône - France | Contact (sur clinicalTrials) | ||||
| Hôpital Nord de Marseille - 13015 - Marseille - Provence Alpes Cote d´Azur - France | Contact (sur clinicalTrials) | ||||
| Hôpital Pontchaillou - 35033 - Rennes cedex 9 - Ille-et-Vilaine - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de l'Ouest - Saint-Herblain - Site René Gauducheau - 44805 - Saint-Herblain - Loire-Atlantique - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli-Calmettes - 13273 - Marseille cedex 9 - Bouches-du-Rhône - France | Contact (sur clinicalTrials) | ||||
| Nouvel Hôpital Civil - 67091 - Strasbourg cedex - Alsace - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
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.