Spots Global Cancer Trial Database for OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure
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Trial Identification
Brief Title: OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure
Official Title: A Randomized Phase III Trial of OSE2101 Compared With Chemotherapy (Docetaxel or Pemetrexed) in HLA-A2 Positive Patients With Advanced Non-Small Cell Lung Cancer With Progressive Disease After Immune Checkpoint Inhibitors
Study ID: NCT02654587
Conditions
Study Description
Brief Summary: The aim of this clinical trial was to determine if the therapeutic cancer vaccine OSE2101 (TEDOPI) was more effective than standard chemotherapy (docetaxel or pemetrexed) in treating HLA-A2 positive patients with metastatic NSCLC who progressed after sequential or concurrent chemotherapy and immune checkpoint inhibitor given in first or second-line treatment. The main questions were to compare the survival, the tolerance to treatment and the quality of life of patients between the two arms of treatment (OSE2101 versus standard chemotherapy)
Detailed Description: The study was a two-step randomized (2:1) study. Patients were stratified by histology (non-squamous versus squamous), best response to first-line treatment \[complete response or partial response versus stable disease or progressive disease\] and line of treatment with prior ICI (first-line ICI when combined with platinum-based chemotherapy versus second-line ICI when administered as sequential treatment). Primary endpoint was overall survival (OS). Interim OS futility analysis was planned as per Fleming design. In April 2020 at the time of the interim analysis, a decision was taken to early stop the accrual due to COVID-19 after 219 out of 363 patients were randomized. It led to a decrease of the study power from 80% to 62%. At the time of the interim analysis, a subgroup of patients was identified from stratification factor based on a clinical and biological rationale: those who received ICI second line and having received at least 12 weeks ICI. This subgroup was defined as ICI secondary resistance. The final analysis was carried out in the subgroup of patients with ICI secondary resistance and in all patients (ICI primary and secondary resistance).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
East Valley Hematology and Oncology medical Group, Burbank, California, United States
Georgetown University Hospital, Washington, District of Columbia, United States
BRCR Medical Center, Inc, Boca Raton, Florida, United States
Pontchartrain Cancer Center, Covington, Louisiana, United States
Meyer Cancer Center, Weill Cornell Medecine, New York, New York, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Robert W. Franz Cancer Center, Portland, Oregon, United States
Gesinger Medical Center, Danville, Pennsylvania, United States
Millenium Oncology, Houston, Texas, United States
Nemocnice Jihlava, Onkologické oddelení, Jihlava, , Czechia
Všeobecná Fakultní nemocnice, Praha, , Czechia
Institut Saint Catherine, Avignon, , France
Hôpital Avicenne, Bobigny, , France
Institut Bergonié, Bordeaux, , France
CHGU Morvan - Brest, Brest, , France
Hôpital Louis Pradel, Bron, , France
Centre Hospitalier de Cholet, Cholet, , France
Hôpital intercommunal de Créteil, Créteil, , France
CHU Grenoble, Grenoble, , France
Clinique Victor Hugo, Le Mans, , France
Centre Hospitalier du Mans, Le Mans, , France
Hopital Albert Calmette, Lille, , France
Paoli-Calmettes Institute, Marseille, , France
CHU Montpellier, Montpellier, , France
Hôpital Emile Muller, Mulhouse, , France
Centre Catherine de Sienne, Nantes, , France
Hôpital Saint-Louis, Paris, , France
Hôpital Bichat - Claude-Bernard, Paris, , France
Hôpital Tenon, Paris, , France
Hôpital d'Instruction des Armées Bégin, Saint Mandé, , France
CHU de Strasbourg - Hôpital Civil, Strasbourg, , France
Hôpital Larrey - CHU de Toulouse, Toulouse, , France
Centre Hospitalier Régional Universitaire de Tours, Tours, , France
Centre Hospitalier Troyes, Troyes, , France
Institut Gustave Roussy (IGR), Villejuif, , France
Krankenhaus Mehrheit - Kliniken der Stadt Köln - Lungenklinik, Cologne, , Germany
Klinik für Innere Medizin II Hospital Martha-Maria Halle-Dölau gGmbH, Halle, , Germany
Universitätsklinikum Tübingen Medizinische Klinik II, Tubingen, , Germany
Klinik für Innere Medizin II Universitätsklinikum Ulm, Ulm, , Germany
Magyar Honvedseg Egeszsegugyi Kozpont II szamu telephely, Budapest, , Hungary
Országos Korányi TBC és Pulmonológiai Intézet XI Tüdőbelosztály, Budapest, , Hungary
Országos Korányi TBC és Pulmonológiai Intézet XIV Tüdőbelosztály, Budapest, , Hungary
Semmelweis Egyetem Altalanos Orvostudományi Kar Pulmonologiai Klinika, Budapest, , Hungary
Csongrad Megyei Mellkasi Betegsegek Szakkorháza I Tüdőosztály, Deszk, , Hungary
Matrai Gyogyintézet, Mátraháza, , Hungary
Soroka University Medical Center, Be'er Sheva, , Israel
Rambam Health Care Campus, Haifa, , Israel
Hadassah Campus Ein Kerem, Jerusalem, , Israel
Meir Medical Center, Kefar Saba, , Israel
Rabin (Belinson) Medical Center, Petah tikva, , Israel
IRCCS Oncologico Giovanni Paolo II, Bari, , Italy
Unità Operativa di Oncologia dell'Ospedale Vito Fazzi di Lecce, Piazza Muratore, Lecce, , Italy
Oncologia medica, Legnano, , Italy
Azienda USL 2 Lucca - Dipartimento Oncologico, Lucca, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T), Meldola, , Italy
U.O.C. Pneumologia a indirizzo oncologico, Presidio Ospedaliero Monaldi - Azienda Ospedaliera dei Colli - Via Leonardo Bianchi, Napoli, , Italy
Istituto Oncologico Veneto, IRCCS, Padova, , Italy
Ospedale di Perugia - Oncologia medica, Perugia, , Italy
U.O. Oncologia Ospedale Infermi, Rimini, , Italy
UOC di Oncologia Medica, Policlinico Universitario Campus Biomedico, Roma, , Italy
IRCCS Regina Elena National Cancer Institute, Roma, , Italy
Policlinico Santa Maria alle Scotte, Siena, , Italy
Ospedale Civile Maggiore, Verona, , Italy
Klinika Onkologii i Radioterapii , Uniwersyteckie Centrum Kliniczne, Gdańsk, , Poland
Przychodnia Lekarska "KOMED", Konin, , Poland
Mazowieckie Centrum Leczenia chorób Płuc i Gruźlicy, Otwock, , Poland
Wojewódzki Szpital Zespolony , Oddział Chemioterapii Nowotworów, Toruń, , Poland
Hospital Universitari Quirón Dexeus, Barcelona, , Spain
Hospital Universitari Vall D'Hebron, Barcelona, , Spain
Hospital de Mataro, Barcelona, , Spain
Hospital Universitario Germans Trias i Pujol, Barcelona, , Spain
"Complejo Hospitalario Universitario A Coruna (CHUAC)", La Coruña, , Spain
Hospital Universitario La Paz Servicio de Oncología Médica, Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda Servicio de Oncología Médica Consultas externas, 2ª planta, Madrid, , Spain
Hospital de Mataro, Mataró, , Spain
Hospital Universitario Carlos Haya, Málaga, , Spain
Milton Keynes Hospital, Milton Keynes, , United Kingdom
Contact Details
Name: Dominique Costantini, Dr
Affiliation: OSE Immunotherapeutics
Role: STUDY_DIRECTOR
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