Study Comparing OSE2101 and Docetaxel for Patients with Metastatic Non-Small Cell Lung Cancer After Immunotherapy Resistance

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as metastatic Non-Small Cell Lung Cancer (NSCLC). The study is specifically for patients who have a certain genetic marker called HLA-A2 and have experienced a return of cancer after initial treatment with immune therapy. The trial will compare two treatments: a cancer vaccine called OSE2101 (also known by its code name TEDOPI) and a chemotherapy drug called docetaxel. The purpose of the study is to determine which treatment is more effective in helping patients live longer.

Participants in the study will receive either the cancer vaccine or the chemotherapy drug. The cancer vaccine, OSE2101, is given as an injection under the skin, while docetaxel is administered through an intravenous infusion, which means it is given directly into a vein. The study will last for up to 24 months, during which time the health and progress of the participants will be closely monitored by the research team. The main goal is to see which treatment helps patients live longer, regardless of the cause of death.

This study is important for patients with NSCLC who have not responded to previous immune therapy treatments. By comparing the cancer vaccine with chemotherapy, researchers hope to find a more effective treatment option for these patients. The trial will provide valuable information on the safety and effectiveness of OSE2101 compared to docetaxel, potentially leading to better treatment strategies for this type of lung cancer.

1 randomization

Upon joining the study, the patient is randomly assigned to one of two treatment groups: one receiving the therapeutic cancer vaccine OSE2101 and the other receiving the chemotherapy drug docetaxel.

2 treatment administration

Patients in the OSE2101 group receive the vaccine as a subcutaneous injection. The specific dosage and frequency are determined by the study protocol.

Patients in the docetaxel group receive the drug intravenously. The dosage and frequency are also determined by the study protocol.

3 monitoring and assessments

Throughout the trial, patients undergo regular monitoring to assess their health and the effectiveness of the treatment. This includes physical examinations, blood tests, and imaging studies as required by the study protocol.

4 follow-up

After completing the treatment phase, patients continue to be monitored for a specified period to evaluate long-term effects and overall survival. The duration of follow-up is determined by the study protocol.

Who Can Join the Study?

  • Must be a male or female aged 18 years or older.
  • If applicable, must have a break of at least 28 days or 5 half-lives (whichever is shorter) since the last cancer treatment or experimental therapy before starting the study treatment. Also, a break of at least 28 days after major surgery or definitive radiation, and at least 2 weeks after palliative radiation.
  • Women who can have children must agree to use very effective birth control methods before joining the study, during the study, and for 180 days after the last dose of study treatment. These methods include hormonal birth control that stops ovulation, intrauterine devices (IUDs), or other reliable methods.
  • Men with partners who can have children must agree to use condoms during the study and for 90 days after the last dose of study treatment. Their partners can use hormone-based birth control since they are not receiving the study treatment.
  • Women who can have children must have a negative pregnancy test during screening and within 24 hours before each study treatment. Women who are postmenopausal for at least 1 year or are surgically sterilized do not need this test.
  • Must have signed and dated an informed consent form before any trial-specific procedures.
  • Must be part of a social security system as required by local regulations.
  • Must have a specific blood type called HLA-A2 phenotype confirmed by a pre-screening test.
  • Must have a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC) that has spread to other parts of the body and is not suitable for surgery or radiation. Must not have certain gene changes that allow for targeted therapy, unless there is no local access to such therapy.
  • Must have experienced cancer progression after at least 24 weeks of a specific first-line treatment, including at least 12 weeks of a type of therapy called anti-PD(L)1. A tumor assessment is needed to confirm this.
  • Must have stopped the specific therapy due to cancer progression after at least 24 weeks, including at least 12 weeks of anti-PD(L)1 therapy.
  • Must have an ECOG performance status of 0 or 1, which indicates the ability to carry out daily activities.
  • Must have measurable or non-measurable cancer lesions according to a standard called RECIST 1.1.
  • Must have adequate organ function, which includes specific levels of proteins and enzymes in the blood, as well as certain blood cell counts and kidney function.
  • Must not have significant ongoing side effects from previous treatments, except for hair loss.

Who Cannot Join the Study?

  • Patients who do not have the HLA-A2 positive phenotype. This means their body does not have a specific type of protein on their cells.
  • Patients who do not have metastatic Non-Small Cell Lung Cancer. This is a type of lung cancer that has spread to other parts of the body.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Site Name City Country Status
Centre Hospitalier Departemental Vendee La Roche sur Yon France
General University Hospital Of Larissa Larissa Greece
IRCCS Humanitas Research Hospital Rozzano Italy
Laiko General Hospital Of Athens Athens Greece
Institut Paoli-Calmettes Cancer Centre Marseille France
Hospital Vall d’Hebron Barcelona Spain
Hospital Universitario da A Coruna A Coruna Galicia Spain
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Centre Hospitalier Intercommunal Creteil Creteil France
Ospedale San Raffaele S.r.l. Milan Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. Meldola Italy
Assistance Publique Hopitaux De Marseille Marseille France
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Rotterdam The Netherlands
IRCCS Ospedale Policlinico San Martino Genoa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Jessa Ziekenhuis Hasselt Belgium
CHRU De Nancy Vandoeuvre Les Nancy France
Centre Hospitalier De La Cote Basque Bayonne France
General University Hospital Of Patras Patras Greece
Justus-Liebig-Universitaet Giessen Giessen Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Centre Hospitalier Universitaire De Rennes Rennes France
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Uniwersyteckie Centrum Kliniczne Gdansk Poland
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Universitaetsklinikum Essen AöR Essen Germany
Institut Gustave Roussy Villejuif France
I.F.O. Istituti Fisioterapici Ospitalieri Rome Italy
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
Universitair Medisch Centrum Groningen Groningen The Netherlands
Universitaetsklinikum Aachen AöR Aachen Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Institut Catala D’oncologia L'hospitalet De Llobregat Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz Madrid Spain
Az Maria Middelares Gent Gent Belgium
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli Naples Italy
University General Hospital Of Heraklion Heraklion Greece
CHU Grenoble Alpes La Tronche France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Hôpitaux Universitaires Strasbourg – Hôpital de Hautepierre STRASBOURG, Alsace France
Istituto Oncologico Veneto Padua Italy
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Theageneio Cancer Hospital Thessaloniki Greece
Koranyi National Institute For Pulmonology Budapest Hungary
Centre Hospitalier Et Universitaire De Limoges Limoges France
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Centre Hospitalier Le Mans Le Mans France
Stichting Radboud University Medical Center Nijmegen The Netherlands
Besancon University Hospital Center Besançon France
Azienda Ospedaliera Universitaria Senese Siena Italy
Hospital Universitario Lucus Augusti Lugo Spain
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Muenchen Klinik gGmbH Munich Germany
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace Mulhouse France
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
General Oncological Hospital Of Kifissia Agioi Anargyroi Kifissia Greece
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience Paris France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Robert Bosch Gesellschaft fuer medizinische Forschung mbH Stuttgart Germany
San Camillo Forlanini Hospital Rome Italy
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Henry Dunant Hospital Center Athens Greece
Comite Entreprise Paul Papin Angers France
Centro Hospitalar E Universitario De Coimbra E.P.E. Coimbra Portugal
Azienda Ospedaliero Universitaria Pisana Pisa Italy

Other Sites

Site Name City Country Status
Clinexpert Kft. Budapest Hungary
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
Hospital Son Llatzer Palma Spain
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A. Peschiera Del Garda Italy
Institut Sainte Catherine Avignon France
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Metropolitan Hospital Athens Greece
St. Savas Hospita Athens Greece
Kwjpnyma Kbkjeh Grpo Kassel Germany
Azolvqzrz Kyjqzn Gbrnwxs Glgh Gauting Germany
Adwnsnve Zwxzoxtlda Knikr Brasschaat Belgium
Cbuspc Hpfztaanwpc Upjnrccqnrknf Dxcboi Gatmcex Srzddhmsirgytdntdofkdzdcrg Namur Belgium
Akrllpmh Zzxtjaincr Gddqocmdo Kortrijk Belgium
Hchztvvo Cxc Poenf Skkv Porto Portugal
Onnktpxt Vgln Fxzuy Lyiqk Lecce Italy
Mawemg Gaiykgkckrom Gyongyos Hungary
Gddhzvm Hjzwhusq Oc Twtmfsbddhxr Ptxnfxmhbnvi Thessaloniki Greece
Augqusv Utw Trhdxwe nrnb oeudm Leghorn Italy
Pudllwenbvu Lajeaeyo &enofnnnspkrjrvswrho Rtwqo Knwakubpphn Konin Poland
Dxuyoocki Cdhehbnv De Sorwchh Dt Sojba Dep Abfptw Toulon France
Ovnglxe Sahmle Timisoara Romania
Cyyzbp Hvjhhgxphgm Dl Cvnaxr Cholet France
Ssc Lylyfkaoeeeq Huliypdz Srhh Thessaloniki Greece
Wgvjbkxbnarni Cnkhqfh Ppnhmxbyebef I Tapklqcqoamotww Icr Ewncetg I Jnsiltr Zozsxordt Poznan Poland
Uyoxzzl Lrugy Dc Sasnf Dw Gyzxahxvcgqs Efuupr Vila Nova De Gaia Portugal
Akuyurobav Ibxhtamav Do Ipcfsnguwfhxi Ssqftdbys Bzynofvzam Barakaldo Spain
Hwqpdtxs Ciz Diccpymcqsn Sytw Lisbon Portugal
Mskztyhcldrx Kaxmmyndowf Hktqxgvimmec giksv Halle (Saale) Germany
Mqgyuvmm Cqexwb Sujshn Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
02.09.2024
France France
Recruiting
02.09.2024
Germany Germany
Recruiting
02.09.2024
Greece Greece
Recruiting
02.09.2024
Hungary Hungary
Recruiting
02.09.2024
Italy Italy
Recruiting
02.09.2024
Poland Poland
Recruiting
02.09.2024
Portugal Portugal
Recruiting
02.09.2024
Romania Romania
Recruiting
02.09.2024
Spain Spain
Recruiting
02.09.2024
The Netherlands The Netherlands
Recruiting
02.09.2024

Trial locations

OSE2101 is an investigational medication being studied for its potential to improve survival in patients with metastatic Non-Small Cell Lung Cancer (NSCLC) who have developed resistance to immune checkpoint inhibitors. It is designed to work by stimulating the immune system to better recognize and attack cancer cells.

Docetaxel is a chemotherapy medication commonly used to treat various types of cancer, including Non-Small Cell Lung Cancer (NSCLC). It works by interfering with the growth and division of cancer cells, ultimately leading to their death. In this trial, it is being used as a comparison to evaluate the effectiveness of OSE2101.

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. As it progresses, patients may experience symptoms like persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some tumors growing slowly and others more rapidly. It is often diagnosed at an advanced stage when it has already metastasized to other organs.

Trial ID:
2023-509340-10-00
Protocol code:
OSE2101C302
Trial Phase:
Therapeutic confirmatory (Phase III)

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