Clinical trial • Phase III • Oncology
MPS-112, MPS-106, MPS-213, MPS-102, MPS-216, MPS-103, MPS-215, MPS-214, D-ALA-LYS-CHA-VAL-ALA-ALA-TRP-THR-LEU-LYS-ALA-ALA-D-ALA, MPS-200 for Non-small cell lung cancer
Phase III trial of MPS-112, MPS-106, MPS-213, MPS-102, MPS-216, MPS-103, MPS-215, MPS-214, D-ALA-LYS-CHA-VAL-ALA-ALA-TRP-THR-LEU-LYS-ALA-ALA-D-ALA, MPS-20…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer
- Trial Stage
- Phase III
- Drug Modality
- Vaccine|Small molecule
Key dates
- Initial CTIS Submission Date
- 06-05-2024
- First CTIS Authorization Date
- 03-09-2024
Trial design
Randomised, open-label, docetaxel 75 mg/m2 intravenous (concentrate for solution for infusion) (max daily dose 75 mg/m2 as listed in product information).-controlled Phase III trial in Portugal, Germany, Poland and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- DOCETAXEL 75 mg/m2 intravenous (Concentrate for solution for infusion) (max daily dose 75 mg/m2 as listed in product information).
- Biomarker Stratified
- True, biomarker HLA-A2 (HLA-A2 positive)
- Target Sample Size
- 69
- Trial Duration For Participant
- 730
Eligibility
Recruits 69 No vulnerable populations (e.g., children, cognitively impaired) are selected; study enrols adults (≥18 years) only. Patients must provide signed and dated informed consent prior to any trial-specific procedures. Special provisions for WOCBP: negative pregnancy test at screening and within 24 hours prior to each administration and contraceptive requirements are specified. Patients with severe psychiatric or incapacitating conditions are excluded..
- Pregnancy Exclusion
- Pregnant or breastfeeding woman.
- Vulnerable Population
- No vulnerable populations (e.g., children, cognitively impaired) are selected; study enrols adults (≥18 years) only. Patients must provide signed and dated informed consent prior to any trial-specific procedures. Special provisions for WOCBP: negative pregnancy test at screening and within 24 hours prior to each administration and contraceptive requirements are specified. Patients with severe psychiatric or incapacitating conditions are excluded.
Inclusion criteria
- {"criterion_text":"- Male or female, aged ≥ 18 years\n- If applicable, before study treatment (OSE2101 or docetaxel) administration, a wash out of at least 21 days or 5 half-lives (whichever is shorter) since the last anticancer treatment or investigational therapy; a wash out of at least 28 days after definitive radiation or prior major surgery; wash out after palliative radiation of at least 2 weeks\n- Women of childbearing potential (WOCBP) participating in the study must agree to use highly effective methods of contraception (i.e., one that results in a less than 1% per year failure rate when used consistently and correctly) prior to study entry, during the study, and for 180 days after the last dose of study treatment. Highly effective methods of contraception are defined as one of the following methods: combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence\n- Male patient with WOCBP partner must be willing to use male contraception (condoms) during the study, and for 90 days after the last dose of study treatment. WOCBP partners of male subjects participating in the study may use hormone-based contraceptives as one of the acceptable methods of contraception since they will not be receiving the study treatment (i.e.; oral hormonal contraception, cap, diaphragm, or sponge with spermicide)\n- WOCBP must have a highly sensitive or serum pregnancy negative test during screening and within 24 hours prior to each administration of the study treatment (OSE2101 or docetaxel). Women who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilised do not require this test\n- Patients having signed and dated informed consent (IC) prior to any trial-specific procedures\n- Patients must be affiliated to a social security system per local regulation (such as in France).\n- Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory\n- 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; for patients with squamous NSCLC, the molecular tests are not mandatory if age ≥ 50 years old and smoker ≥ 15 pack years; 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’ agreement\n- Patients with metastatic NSCLC who received only one prior line of systemic therapy with CT and ICI, with ICI lasting ≥ 24 weeks, including ≥ 12 weeks of anti-PD(L)1 as monotherapy or in combination with another ICI or an anti-angiogenic prior to randomization (i.e.; ICI secondary resistance); induction treatment with first-line CT-ICI should contain platinum-based CT\n- Patients that experience a radiologically documented PD (assessed by the Investigator) ≥ 24 weeks of ICI, including ≥ 12-weeks of anti-PD(L)1 as monotherapy or in combination with another ICI or an anti-angiogenic prior to randomization; patients who permanently stopped ICI after a protocol specified cessation of ICI according to site’ practice and patients after having permanently stopped ICI due to prior toxicity that is resolved or not clinically significant at time of study entry are authorized\n- Patients with ECOG performance status (PS) 0 or 1\n- Patients with measurable or non-measurable lesions per RECIST 1.1\n- Patients with adequate organ functions defined as: Albumin ≥ 2.8 g/dL ; AST and ALT up to 3.0 x ULN associated with Alkaline Phosphatase (ALKP) ≤ 2.5 x ULN, or ALPK ≥ 2.5 x ULN up to 5.0 x ULN associated with AST and ALT ≤ 1.5 x ULN ; Total serum bilirubin ≤ 1 x ULN; for patients with Gilbert’s syndrome, total bilirubin ≤ 3 ULN or direct bilirubin ≤ 1.5 ULN ; Absolute neutrophil count (ANC) ≥ 1.5 x 109/L ; Platelets ≥ 100 x 109/L ; Haemoglobin ≥ 9 g/dL (in the absence of transfusion within 2 weeks before randomization) ; Creatinine clearance (CrCl) according to CKD-EPI (Chronic Kidney Disease – EPIdemiology) formula ≥ 30 ml/min/1.73m2\n- Patients without clinically significant ongoing toxicity from prior therapy (severity ≤ Grade 1; except alopecia) ; patients with disease necessitating a replacement treatment and well balanced are authorized (e.g., hypo or hyperthyroidism, adrenal insufficiency, diabetes treated by oral anti-glycemic agent and/or insulin therapy…)"}
Exclusion criteria
- {"criterion_text":"- Small-cell lung cancer/mixed NSCLC with small cell component or other neuroendocrine lung cancers (typical and atypical carcinoids, large-cell neuroendocrine carcinomas)\n- Patient participating in another clinical trial with an investigational medicinal product\n- Patient is the Principal Investigator or Investigator, research assistant, pharmacist, study coordinator, other staff directly involved in the conduct of the study\n- Patients with known hypersensitivity to the active substances or to any of the excipients of OSE2101 or docetaxel\n- Patients with current brain metastases, leptomeningeal metastases or carcinomatous meningitis, or previously treated brain metastases, leptomeningeal metastases, or carcinomatous meningitis; patients with spinal cord compression except if due to external causes and duly treated (e.g.; radiation for bone metastasis)\n- Patients with AST and/or ALT >1.5 × ULN concomitant with ALPK > 2.5 × ULN\n- Pregnant or breastfeeding woman.\n- Patients with active auto-immune disease and/or immune-related disease due to prior immunotherapy or other condition requiring systemic immunosuppressive treatments or chronic administration of corticosteroids > 10 mg daily prednisolone equivalent (except as replacement if adrenal insufficiency); short course of corticosteroids > 10 mg daily prednisolone equivalent is allowed if ≤ 10 days continuous duration (e.g. premedication to prevent contrast allergy, drug reaction…); topical, ocular, intra-articular, intranasal, and inhaled corticosteroids with minimal systemic absorption are allowed\n- Patients with interstitial lung disease or active non-infectious pneumonitis\n- Patients who have known hereditary, congenital or acquired immunodeficiencies; for human immunodeficiency virus (HIV) infection, patient may be eligible if CD4+ count ≥ 350 cells/μL, and no history of acquired immunodeficiency syndrome (AIDS) infections within 12 months prior to start of study treatment, and receiving an established antiretroviral therapy with NO known drug-drug interaction with docetaxel for at least 4 weeks prior to starting the study treatment, and have a viral load ≤ 400 copies/μL (local laboratory)\n- Patients with an active infection requiring anti-infective therapy until all signs of infection have resolved before randomization\n- Patients with PD during induction first-line CT-ICI (to exclude hyper progression and fast progression to CT-ICI) or with PD within 24 weeks of ICI; chemotherapy or other cytotoxic agents in combination with ICI within 12 weeks prior to randomization are not authorized;\n- Patients with chronic Hepatitis B (HBV) infection who meet the criteria for antiviral therapy (according to local/international guidelines) and not treated prior to starting the study treatment; patients with an active Hepatitis C (HCV) with HCV viral load (by local laboratory) above the limit of quantification; patients who received a prior antiviral HCV treatment or no prior treatment but HCV natural resolution with HCV RNA not detectable are eligible\n- Patients with other active cancer(s) within 3 years prior to randomization (except appropriately treated non-melanoma skin cancer or localized cervical cancer, or other local tumors considered cured (e.g., localized and presumed cured prostate cancer)\n- Patients with severe acute or chronic medical (i.e., severe liver impairment) or psychiatric or incapacitated conditions, or laboratory abnormalities that would expose to an excess risk associated with study participation or study drug administration in the opinion of the Investigator and/or the Sponsor"}
Endpoints
Primary endpoints
- {"endpoint_text":"- OS defined as time from randomization to death of any cause","definition_or_measurement_approach":"OS defined as time from randomization to death of any cause (time-to-event measured from randomization date to date of death)."}
Recruitment
- Planned Sample Size
- 340
- Recruitment Window Months
- 39
- Consent Approach
- Participants must provide signed and dated informed consent (IC) prior to any trial-specific procedures. There are separate prescreening and pre-screening ICF documents and pregnancy-specific information sheets for WOCBP. Consent materials and ICFs are available in multiple local languages (documents listed for DE, FR, ES, IT, NL, PL, PT, RO, GR, HU and others). No assent procedures for minors are applicable because study enrols adults (≥18 years).
Geography
- Total Number Of Sites
- 119
- Total Number Of Participants
- 340
Portugal
- Earliest CTIS Part Ii Submission Date
- 30-07-2024
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 602
- Number Of Sites
- 6
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Cuf Descobertas S.A.
- Department Name
- Oncology
- Principal Investigator Name
- Li Bei
- Principal Investigator Email
- li.bei@cuf.pt
- Contact Person Name
- Li Bei
- Contact Person Email
- li.bei@cuf.pt
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- Oncological pulmonology
- Principal Investigator Name
- Paula Alves
- Principal Investigator Email
- ana.p.figueiredo@ulssm.min-saude.pt
- Contact Person Name
- Paula Alves
- Contact Person Email
- ana.p.figueiredo@ulssm.min-saude.pt
- Site Name
- Unidade Local De Saude De Gaia/Espinho E.P.E.
- Department Name
- Oncological pulmonology
- Principal Investigator Name
- Ana Barroso
- Principal Investigator Email
- abarroso@ulsge.min-saude.pt
- Contact Person Name
- Ana Barroso
- Contact Person Email
- abarroso@ulsge.min-saude.pt
- Site Name
- Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
- Department Name
- Pneumology
- Principal Investigator Name
- Telma Sequeira
- Principal Investigator Email
- tsequeira@ipolisboa.minsaude.pt
- Contact Person Name
- Telma Sequeira
- Contact Person Email
- tsequeira@ipolisboa.minsaude.pt
- Site Name
- Hospital CUF Porto S.A.
- Department Name
- Oncology
- Principal Investigator Name
- Venceslau Hespanhol
- Principal Investigator Email
- venceslau.hespanhol@cuf.pt
- Contact Person Name
- Venceslau Hespanhol
- Contact Person Email
- venceslau.hespanhol@cuf.pt
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- Pneumology
- Principal Investigator Name
- Ana Figueiredo
- Principal Investigator Email
- amrfigueiredo@gmail.com
- Contact Person Name
- Ana Figueiredo
- Contact Person Email
- amrfigueiredo@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 02-08-2024
- Latest Decision Or Authorization Date
- 05-03-2026
- Processing Time Days
- 580
- Number Of Sites
- 12
- Number Of Participants
- 26
Sites
- Site Name
- LungenClinic Grosshansdorf GmbH
- Department Name
- Dept. of Thoracic Oncology
- Principal Investigator Name
- Mattin Reck
- Principal Investigator Email
- a.gaebler@lungenclinic.de
- Contact Person Name
- Mattin Reck
- Contact Person Email
- a.gaebler@lungenclinic.de
- Site Name
- Justus-Liebig-Universitaet Giessen
- Department Name
- Medical Clinic IV, Organ Oncology
- Principal Investigator Name
- Thomas Wehler
- Principal Investigator Email
- thomas.wehler@innere.med.uni-giessen.de
- Contact Person Name
- Thomas Wehler
- Contact Person Email
- thomas.wehler@innere.med.uni-giessen.de
- Site Name
- Klinikum Kassel GmbH
- Department Name
- Dept. for Hematology, Oncology and Immunology
- Principal Investigator Name
- Barbara Ritter
- Principal Investigator Email
- Barbara.ritter.studien@gnh.net
- Contact Person Name
- Barbara Ritter
- Contact Person Email
- Barbara.ritter.studien@gnh.net
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- Department of Hematology, Oncology, Hemostaseolog y and Stem Cell Transplantation
- Principal Investigator Name
- Jens Peter Panse
- Principal Investigator Email
- jpanse@ukaachen.de
- Contact Person Name
- Jens Peter Panse
- Contact Person Email
- jpanse@ukaachen.de
- Site Name
- Thoraxklinik Heidelberg gGmbH
- Department Name
- Dept. of Thoracic Oncology
- Principal Investigator Name
- Farastuk Bozorgmehr
- Principal Investigator Email
- Farastuk.bozorgmehr@med.uni-heidelberg.de
- Contact Person Name
- Farastuk Bozorgmehr
- Contact Person Email
- Farastuk.bozorgmehr@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Department of Hematology and Oncology (Med. Clinic and Polyclinic III – Internal Medicine)
- Principal Investigator Name
- Peter Brossart
- Principal Investigator Email
- Peter.Brossart@ukbonn.de
- Contact Person Name
- Peter Brossart
- Contact Person Email
- Peter.Brossart@ukbonn.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Lung Tumor Center
- Principal Investigator Name
- Nikolaj Frost
- Principal Investigator Email
- Nikolaj.frost@charite.de
- Contact Person Name
- Nikolaj Frost
- Contact Person Email
- Nikolaj.frost@charite.de
- Site Name
- Asklepios Klinik Gauting GmbH
- Department Name
- Department Pneumology/Oncology
- Principal Investigator Name
- Niels Reinmuth
- Principal Investigator Email
- n.reinmuth@asklepios.com
- Contact Person Name
- Niels Reinmuth
- Contact Person Email
- n.reinmuth@asklepios.com
- Site Name
- Muenchen Klinik gGmbH
- Department Name
- Clinic for Pneumology and Pneumological Oncology
- Principal Investigator Name
- Konrad Kokowski
- Principal Investigator Email
- konrad.kokowski@klinikum-muenchen.de
- Contact Person Name
- Konrad Kokowski
- Contact Person Email
- konrad.kokowski@klinikum-muenchen.de
- Site Name
- Robert Bosch Gesellschaft fuer medizinische Forschung mbH
- Department Name
- Department of Hematology, Oncology and Palliative medicine
- Principal Investigator Name
- Hans-Georg Kopp
- Principal Investigator Email
- hans-georg.kopp@rbk.de
- Contact Person Name
- Hans-Georg Kopp
- Contact Person Email
- hans-georg.kopp@rbk.de
- Site Name
- Martha-Maria Krankenhaus Halle-Doelau gGmbH
- Department Name
- Department for Internal Medicine II
- Principal Investigator Name
- Miriam Moeller
- Principal Investigator Email
- miriam.moeller@martha-maria.de
- Contact Person Name
- Miriam Moeller
- Contact Person Email
- miriam.moeller@martha-maria.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Department of Medical Oncology (Innere Klinik- Tumorforschun g)
- Principal Investigator Name
- Halime Kalkavan
- Principal Investigator Email
- Halime.Kalkavan@uk-essen.de
- Contact Person Name
- Halime Kalkavan
- Contact Person Email
- Halime.Kalkavan@uk-essen.de
Poland
- Earliest CTIS Part Ii Submission Date
- 15-08-2024
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 585
- Number Of Sites
- 6
- Number Of Participants
- 25
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
- Department Name
- Centrum Innowacyjnych Terapii
- Principal Investigator Name
- Tomasz Jankowski
- Principal Investigator Email
- tjankowski.onkolg@wp.pl
- Contact Person Name
- Tomasz Jankowski
- Contact Person Email
- tjankowski.onkolg@wp.pl
- Site Name
- Instytut Centrum Zdrowia Matki Polki
- Department Name
- Klinika Onkologii
- Principal Investigator Name
- Ewa Kalinka
- Principal Investigator Email
- ewakalinka@wp.pl
- Contact Person Name
- Ewa Kalinka
- Contact Person Email
- ewakalinka@wp.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Onkologii i Radioterapii
- Principal Investigator Name
- Rafał Dziadziuszko
- Principal Investigator Email
- rafald@gumed.edu.pl
- Contact Person Name
- Rafał Dziadziuszko
- Contact Person Email
- rafald@gumed.edu.pl
- Site Name
- Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
- Department Name
- Oddział Onkologii Klinicznej z Pododdziałem Dziennej Chemioterapii
- Principal Investigator Name
- Katarzyna Stencel
- Principal Investigator Email
- kstencel@wcpit.org
- Contact Person Name
- Katarzyna Stencel
- Contact Person Email
- kstencel@wcpit.org
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Ambulatorium Chemoterapii I
- Principal Investigator Name
- Bogdan Żurawski
- Principal Investigator Email
- zurawskib@co.bydgoszcz.pl
- Contact Person Name
- Bogdan Żurawski
- Contact Person Email
- zurawskib@co.bydgoszcz.pl
- Site Name
- I Przychodnia Lekarska Komed Roman Karaszewski
- Principal Investigator Name
- Bogusława Karaszewska
- Principal Investigator Email
- komed.badania@gmail.com
- Contact Person Name
- Bogusława Karaszewska
- Contact Person Email
- komed.badania@gmail.com
Romania
- Earliest CTIS Part Ii Submission Date
- 05-06-2024
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 663
- Number Of Sites
- 3
- Number Of Participants
- 16
Sites
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Oncology
- Principal Investigator Name
- Tudor-Eliade Ciuleanu
- Principal Investigator Email
- tudor_ciuleanu@hotmail.com
- Contact Person Name
- Tudor-Eliade Ciuleanu
- Contact Person Email
- tudor_ciuleanu@hotmail.com
- Site Name
- Centrul De Oncologie SF Nectarie S.R.L.
- Department Name
- Oncology
- Principal Investigator Name
- Michael Schenker
- Principal Investigator Email
- mike_schenker@yahoo.com
- Contact Person Name
- Michael Schenker
- Contact Person Email
- mike_schenker@yahoo.com
- Site Name
- Oncomed S.R.L.
- Department Name
- Oncology
- Principal Investigator Name
- Daniela-Elvira Sirbu
- Principal Investigator Email
- desirbu@yahoo.com
- Contact Person Name
- Daniela-Elvira Sirbu
- Contact Person Email
- desirbu@yahoo.com
Hungary
- Earliest CTIS Part Ii Submission Date
- 08-07-2024
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 658
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Clinexpert Kft.
- Principal Investigator Name
- István Albert
- Principal Investigator Email
- albert.magy@gmail.com
- Contact Person Name
- István Albert
- Contact Person Email
- albert.magy@gmail.com
- Site Name
- Matrai Gyogyintezet
- Department Name
- Pulmonology Department
- Principal Investigator Name
- László Urbán
- Principal Investigator Email
- drurban.laszlo@magy.eu
- Contact Person Name
- László Urbán
- Contact Person Email
- drurban.laszlo@magy.eu
- Site Name
- Koranyi National Institute For Pulmonology
- Department Name
- XIV: Pulmonology Department
- Principal Investigator Name
- Gyula Ostoros
- Principal Investigator Email
- drostorosgyula@gmail.com
- Contact Person Name
- Gyula Ostoros
- Contact Person Email
- drostorosgyula@gmail.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 23-08-2024
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 587
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Radboud universitair medisch centrum / RADBOUDUMC
- Department Name
- Pulmonology
- Principal Investigator Name
- Miep van der Drift
- Principal Investigator Email
- miep.vanderdrift@radboudumc.nl
- Contact Person Name
- Miep van der Drift
- Contact Person Email
- miep.vanderdrift@radboudumc.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Pulmonology
- Principal Investigator Name
- Jeroen Hiltermann
- Principal Investigator Email
- t.j.n.hiltermann@umcg.nl
- Contact Person Name
- Jeroen Hiltermann
- Contact Person Email
- t.j.n.hiltermann@umcg.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Pulmonology
- Principal Investigator Name
- Joachim Aerts
- Principal Investigator Email
- j.aerts@erasmusmc.nl
- Contact Person Name
- Joachim Aerts
- Contact Person Email
- j.aerts@erasmusmc.nl
Spain
- Earliest CTIS Part Ii Submission Date
- 07-08-2024
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 628
- Number Of Sites
- 20
- Number Of Participants
- 55
Sites
- Site Name
- Hospital Universitario Lucus Augusti
- Department Name
- Medical Oncology
- Principal Investigator Name
- Sergio Vazquez Estevez
- Principal Investigator Email
- sergio.vazquez.estevez@sergas.es
- Contact Person Name
- Sergio Vazquez Estevez
- Contact Person Email
- sergio.vazquez.estevez@sergas.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Medical Oncology
- Principal Investigator Name
- Antonio Calles Blanco
- Principal Investigator Email
- antonio.calles@live.com
- Contact Person Name
- Antonio Calles Blanco
- Contact Person Email
- antonio.calles@live.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Principal Investigator Name
- Augusto Valdivia Bustamante
- Principal Investigator Email
- augustovaldivia@vhio.net
- Contact Person Name
- Augusto Valdivia Bustamante
- Contact Person Email
- augustovaldivia@vhio.net
- Site Name
- Hospital Universitario La Paz
- Department Name
- Medical Oncology
- Principal Investigator Name
- Francisco Javier de Castro Carpeño
- Principal Investigator Email
- javier.decastro@salud.madrid.org
- Contact Person Name
- Francisco Javier de Castro Carpeño
- Contact Person Email
- javier.decastro@salud.madrid.org
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Medical Oncology
- Principal Investigator Name
- Mariano Provencio Pulla
- Principal Investigator Email
- mprovencio.ensayosclinicos@gmail.com
- Contact Person Name
- Mariano Provencio Pulla
- Contact Person Email
- mprovencio.ensayosclinicos@gmail.com
- Site Name
- Hospital Son Llatzer
- Department Name
- Medical Oncology
- Principal Investigator Name
- Juan Coves Sarto
- Principal Investigator Email
- jcoves@hsll.es
- Contact Person Name
- Juan Coves Sarto
- Contact Person Email
- jcoves@hsll.es
- Site Name
- Institut Catala D'oncologia (Badalona)
- Department Name
- Medical Oncology
- Principal Investigator Name
- María Teresa Morán Bueno
- Principal Investigator Email
- mmoran@iconcologia.net
- Contact Person Name
- María Teresa Morán Bueno
- Contact Person Email
- mmoran@iconcologia.net
- Site Name
- Micancer Center S.L.P.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Santiago Viteri Ramírez
- Principal Investigator Email
- sviteri@uomi.es
- Contact Person Name
- Santiago Viteri Ramírez
- Contact Person Email
- sviteri@uomi.es
- Site Name
- Hospital Universitari Dexeus Grupo Quironsalud
- Department Name
- Medical Oncology
- Principal Investigator Name
- Andrés Aguilar Hernandez
- Principal Investigator Email
- aaguilar@oncorosell.com
- Contact Person Name
- Andrés Aguilar Hernandez
- Contact Person Email
- aaguilar@oncorosell.com
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Medical Oncology
- Principal Investigator Name
- Alexandra Cantero Gonzalez
- Principal Investigator Email
- alexandracantero.eecc@gmail.com
- Contact Person Name
- Alexandra Cantero Gonzalez
- Contact Person Email
- alexandracantero.eecc@gmail.com
- Site Name
- Biocruces Bizkaia Health Research Institute
- Department Name
- Medical Oncology
- Principal Investigator Name
- Raquel Casas Cornejo
- Principal Investigator Email
- RAQUEL.CASASCORNEJO@osakidetza.eus
- Contact Person Name
- Raquel Casas Cornejo
- Contact Person Email
- RAQUEL.CASASCORNEJO@osakidetza.eus
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Medical Oncology
- Principal Investigator Name
- Maria Eugenia Olmedo García
- Principal Investigator Email
- mariaeugenia.olmedo@salud.madrid.org
- Contact Person Name
- Maria Eugenia Olmedo García
- Contact Person Email
- mariaeugenia.olmedo@salud.madrid.org
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Medical Oncology
- Principal Investigator Name
- Noemi Reguart Aransay
- Principal Investigator Email
- nreguart@clinic.cat
- Contact Person Name
- Noemi Reguart Aransay
- Contact Person Email
- nreguart@clinic.cat
- Site Name
- Institut Catala D'oncologia (Girona)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Joaquim Bosch-Barrera
- Principal Investigator Email
- jbosch@iconcologia.net
- Contact Person Name
- Joaquim Bosch-Barrera
- Contact Person Email
- jbosch@iconcologia.net
- Site Name
- H.C. Hospitales S.L.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jose Manuel Trigo Perez
- Principal Investigator Email
- jmtrigo@seom.org
- Contact Person Name
- Jose Manuel Trigo Perez
- Contact Person Email
- jmtrigo@seom.org
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Medical Oncology
- Principal Investigator Name
- Maria Rosario García Campelo
- Principal Investigator Email
- ma.rosario.garcia.campelo@sergas.es
- Contact Person Name
- Maria Rosario García Campelo
- Contact Person Email
- ma.rosario.garcia.campelo@sergas.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Medical Oncology
- Principal Investigator Name
- Teresa Garcia Manrique
- Principal Investigator Email
- tgarciamanrique.onco@gmail.com
- Contact Person Name
- Teresa Garcia Manrique
- Contact Person Email
- tgarciamanrique.onco@gmail.com
- Site Name
- Institut Catala D'oncologia (L'hospitalet)
- Department Name
- Medical Oncology
- Principal Investigator Name
- Ernesto Nadal Alforja
- Principal Investigator Email
- esnadal@iconcologia.net
- Contact Person Name
- Ernesto Nadal Alforja
- Contact Person Email
- esnadal@iconcologia.net
- Site Name
- Complejo Hospitalario Universitario Insular Materno Infantil
- Department Name
- Medical Oncology
- Principal Investigator Name
- Delvys Rodríguez Abreu
- Principal Investigator Email
- drodabr@gobiernodecanarias.org
- Contact Person Name
- Delvys Rodríguez Abreu
- Contact Person Email
- drodabr@gobiernodecanarias.org
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Oncology
- Principal Investigator Name
- Isidoro Carlos Barneto Aranda
- Principal Investigator Email
- isidoroc.barneto.sspa@juntadeandalucia.es
- Contact Person Name
- Isidoro Carlos Barneto Aranda
- Contact Person Email
- isidoroc.barneto.sspa@juntadeandalucia.es
Italy
- Earliest CTIS Part Ii Submission Date
- 01-08-2024
- Latest Decision Or Authorization Date
- 24-03-2026
- Processing Time Days
- 600
- Number Of Sites
- 17
- Number Of Participants
- 37
Sites
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- Oncologia medica 2
- Principal Investigator Name
- Frederico Cappuzzo
- Principal Investigator Email
- federico.cappuzzo@ifo.it
- Contact Person Name
- Frederico Cappuzzo
- Contact Person Email
- federico.cappuzzo@ifo.it
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Marco Tagliamento
- Principal Investigator Email
- marco.tagliamento@unige.it
- Contact Person Name
- Marco Tagliamento
- Contact Person Email
- marco.tagliamento@unige.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- UOC Oncoematologia
- Principal Investigator Name
- Carminia Maria Della Corte
- Principal Investigator Email
- carminiamaria.dellacorte@unicampania.it
- Contact Person Name
- Carminia Maria Della Corte
- Contact Person Email
- carminiamaria.dellacorte@unicampania.it
- Site Name
- San Camillo Forlanini Hospital
- Department Name
- Pneumo-Oncologia
- Principal Investigator Name
- Serena Ricciardi
- Principal Investigator Email
- sricciardi@scamilloforlanini.rm.it
- Contact Person Name
- Serena Ricciardi
- Contact Person Email
- sricciardi@scamilloforlanini.rm.it
- Site Name
- Azienda Ospedaliera Universitaria Senese
- Department Name
- UOC Immunoterapia Oncologica
- Principal Investigator Name
- Michele Maio
- Principal Investigator Email
- mmaiocro@gmail.com
- Contact Person Name
- Michele Maio
- Contact Person Email
- mmaiocro@gmail.com
- Site Name
- Azienda Unita Sanitaria Locale Toscana Nord Ovest
- Department Name
- Oncologia
- Principal Investigator Name
- Editta Baldini
- Principal Investigator Email
- editta.baldini@uslnordovest.toscana.it
- Contact Person Name
- Editta Baldini
- Contact Person Email
- editta.baldini@uslnordovest.toscana.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- SCDU Oncologia
- Principal Investigator Name
- Gloria Borra
- Principal Investigator Email
- gloria.borra@maggioreosp.novara.it
- Contact Person Name
- Gloria Borra
- Contact Person Email
- gloria.borra@maggioreosp.novara.it
- Site Name
- Ospedale Vito Fazzi Lecce
- Department Name
- U.O. MedicalOncology
- Principal Investigator Name
- Gianpiero Diego Romano
- Principal Investigator Email
- giampieroromano@tiscali.it
- Contact Person Name
- Gianpiero Diego Romano
- Contact Person Email
- giampieroromano@tiscali.it
- Site Name
- Istituto Oncologico Veneto
- Department Name
- U.O.C. Oncologia 2
- Principal Investigator Name
- Laura Bonanno
- Principal Investigator Email
- laura.bonanno@iov.veneto.it
- Contact Person Name
- Laura Bonanno
- Contact Person Email
- laura.bonanno@iov.veneto.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Oncologia Medica ed Ematologia
- Principal Investigator Name
- Luca Toschi
- Principal Investigator Email
- luca.toschi@cancercenter.humanitas.it
- Contact Person Name
- Luca Toschi
- Contact Person Email
- luca.toschi@cancercenter.humanitas.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- UOC Oncologia Medica
- Principal Investigator Name
- Roberto Ferrara
- Principal Investigator Email
- ferrara.roberto@hsr.it
- Contact Person Name
- Roberto Ferrara
- Contact Person Email
- ferrara.roberto@hsr.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- SCDU Oncologia Medica
- Principal Investigator Name
- Silvia Novello
- Principal Investigator Email
- silvia.novello@unito.it
- Contact Person Name
- Silvia Novello
- Contact Person Email
- silvia.novello@unito.it
- Site Name
- Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.
- Department Name
- U.O. Thoracic Oncology – Lung unit
- Principal Investigator Name
- Antonio Santo
- Principal Investigator Email
- antonio.santo@ospedalepederzoli.it
- Contact Person Name
- Antonio Santo
- Contact Person Email
- antonio.santo@ospedalepederzoli.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Medical Oncology 1
- Principal Investigator Name
- Giuseppe Lo Russo
- Principal Investigator Email
- giuseppe.lorusso@istitutotumori.mi.it
- Contact Person Name
- Giuseppe Lo Russo
- Contact Person Email
- giuseppe.lorusso@istitutotumori.mi.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Pneumologia
- Principal Investigator Name
- Antonio Chella
- Principal Investigator Email
- anto.kell@tiscali.it
- Contact Person Name
- Antonio Chella
- Contact Person Email
- anto.kell@tiscali.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Oncologia Toracica
- Principal Investigator Name
- Angelo Delmonte
- Principal Investigator Email
- angelo.delmonte@irst.emr.it
- Contact Person Name
- Angelo Delmonte
- Contact Person Email
- angelo.delmonte@irst.emr.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- UO Oncologia
- Principal Investigator Name
- Davide Tassinari
- Principal Investigator Email
- davide.tassinari@auslromagna.it
- Contact Person Name
- Davide Tassinari
- Contact Person Email
- davide.tassinari@auslromagna.it
Greece
- Earliest CTIS Part Ii Submission Date
- 05-06-2024
- Latest Decision Or Authorization Date
- 17-02-2026
- Processing Time Days
- 622
- Number Of Sites
- 12
- Number Of Participants
- 36
Sites
- Site Name
- Thoracic General Hospital Of Athens I Sotiria
- Department Name
- Oncology Unit, 3rd Department of Internal Medicine and Laboratory
- Principal Investigator Name
- Konstantinos Syrigos
- Principal Investigator Email
- ksyrigos.trials@gmail.com
- Contact Person Name
- Konstantinos Syrigos
- Contact Person Email
- ksyrigos.trials@gmail.com
- Site Name
- St. Luke's Hospital S.A.
- Department Name
- Oncology Department
- Principal Investigator Name
- Eleni Fountzila
- Principal Investigator Email
- elenafou@gmail.com
- Contact Person Name
- Eleni Fountzila
- Contact Person Email
- elenafou@gmail.com
- Site Name
- Theageneio Cancer Hospital
- Department Name
- Pulmonology - Oncology Department
- Principal Investigator Name
- Theodora Tsiouda
- Principal Investigator Email
- doratsiouda@yahoo.gr
- Contact Person Name
- Theodora Tsiouda
- Contact Person Email
- doratsiouda@yahoo.gr
- Site Name
- General Hospital Of Thessaloniki Papageorgiou
- Department Name
- Medical Oncology Department of AUTh.
- Principal Investigator Name
- Eleni Timotheadou
- Principal Investigator Email
- timotheadoue@gmail.com
- Contact Person Name
- Eleni Timotheadou
- Contact Person Email
- timotheadoue@gmail.com
- Site Name
- General University Hospital Of Patras
- Department Name
- Division of Oncology, Department of Medicine
- Principal Investigator Name
- Angelos Koutras
- Principal Investigator Email
- angkoutr@otenet.gr
- Contact Person Name
- Angelos Koutras
- Contact Person Email
- angkoutr@otenet.gr
- Site Name
- Henry Dunant Hospital Center (Athens)
- Department Name
- 4th Oncology Department & Clinical Trials Unit
- Principal Investigator Name
- Ioannis Mountzios
- Principal Investigator Email
- gmountzios@gmail.com
- Contact Person Name
- Ioannis Mountzios
- Contact Person Email
- gmountzios@gmail.com
- Site Name
- Henry Dunant Hospital Center (Athens contact 2)
- Department Name
- 1st Oncology Department
- Principal Investigator Name
- Avraam Assi
- Principal Investigator Email
- avraamassi@gmail.com
- Contact Person Name
- Avraam Assi
- Contact Person Email
- avraamassi@gmail.com
- Site Name
- General University Hospital Of Larissa
- Department Name
- Medical Oncology
- Principal Investigator Name
- Athanasios Kotsakis
- Principal Investigator Email
- thankotsakis@hotmail.com
- Contact Person Name
- Athanasios Kotsakis
- Contact Person Email
- thankotsakis@hotmail.com
- Site Name
- General Oncological Hospital Of Kifissia Agioi Anargyroi
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Konstantinos Laschos
- Principal Investigator Email
- konstantinos.laschos@gmail.com
- Contact Person Name
- Konstantinos Laschos
- Contact Person Email
- konstantinos.laschos@gmail.com
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Medical Oncology Department
- Principal Investigator Name
- Dimitrios Mavroudis
- Principal Investigator Email
- mavroudis@uoc.gr
- Contact Person Name
- Dimitrios Mavroudis
- Contact Person Email
- mavroudis@uoc.gr
- Site Name
- St. Savas Hospita
- Department Name
- 1st Medical Oncology Department
- Principal Investigator Name
- Alexandros Ardavanis
- Principal Investigator Email
- ardavanis@yahoo.com
- Contact Person Name
- Alexandros Ardavanis
- Contact Person Email
- ardavanis@yahoo.com
- Site Name
- Metropolitan Hospital
- Department Name
- 4th Oncology Department
- Principal Investigator Name
- Helena Linardou
- Principal Investigator Email
- elinardou@otenet.gr
- Contact Person Name
- Helena Linardou
- Contact Person Email
- elinardou@otenet.gr
France
- Earliest CTIS Part Ii Submission Date
- 22-07-2024
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 644
- Number Of Sites
- 27
- Number Of Participants
- 77
Sites
- Site Name
- GIE Groupe hospitalier Paris Saint-Joseph/Vinci
- Department Name
- Oncologie
- Principal Investigator Name
- Charles Naltet
- Principal Investigator Email
- cnaltet@ghpsj.fr
- Contact Person Name
- Charles Naltet
- Contact Person Email
- cnaltet@ghpsj.fr
- Site Name
- Besancon University Hospital Center
- Department Name
- Pneumo- Oncologie
- Principal Investigator Name
- Virginie Westeel
- Principal Investigator Email
- virginie.westeel@univ-fcomte.fr
- Contact Person Name
- Virginie Westeel
- Contact Person Email
- virginie.westeel@univ-fcomte.fr
- Site Name
- Hospices Civils De Lyon (Bron)
- Department Name
- Pulmonology
- Principal Investigator Name
- Sébastian Couraud
- Principal Investigator Email
- sebastien.couraud@chu-lyon.fr
- Contact Person Name
- Sébastian Couraud
- Contact Person Email
- sebastien.couraud@chu-lyon.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Oncologie Medicale
- Principal Investigator Name
- Anne Madroszyk- Flandin
- Principal Investigator Email
- madroszyka@ipc.unicancer.fr
- Contact Person Name
- Anne Madroszyk- Flandin
- Contact Person Email
- madroszyka@ipc.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Pôle Thorax et Vaisseaux – Unité d’Oncologie Thoracique
- Principal Investigator Name
- Denis Moro-Sibilot
- Principal Investigator Email
- Dmoro-sibilot@chu-grenoble.fr
- Contact Person Name
- Denis Moro-Sibilot
- Contact Person Email
- Dmoro-sibilot@chu-grenoble.fr
- Site Name
- Direction Centrale Du Service De Sante Des Armees (Toulon)
- Department Name
- Pneumologie
- Principal Investigator Name
- Nicolas Paleiron
- Principal Investigator Email
- nicolas.paleiron@intradef.gouv.fr
- Contact Person Name
- Nicolas Paleiron
- Contact Person Email
- nicolas.paleiron@intradef.gouv.fr
- Site Name
- Sainte Catherine Institut Du Cancer Avignon-Provence
- Department Name
- Oncologie
- Principal Investigator Name
- Magali RAVOIRE
- Principal Investigator Email
- m.ravoire@isc84.org
- Contact Person Name
- Magali RAVOIRE
- Contact Person Email
- m.ravoire@isc84.org
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Thoracic oncology unit – pulmonary department
- Principal Investigator Name
- Benoit Roch
- Principal Investigator Email
- b-roch@chu-montpellier.fr
- Contact Person Name
- Benoit Roch
- Contact Person Email
- b-roch@chu-montpellier.fr
- Site Name
- Centre Hospitalier Le Mans
- Department Name
- Pneumology
- Principal Investigator Name
- Olivier Molinier
- Principal Investigator Email
- omolinier@ch-lemans.fr
- Contact Person Name
- Olivier Molinier
- Contact Person Email
- omolinier@ch-lemans.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Pneumology and Oncology department
- Principal Investigator Name
- Celine Mascaux
- Principal Investigator Email
- celine.mascaux@chru-strasbourg.fr
- Contact Person Name
- Celine Mascaux
- Contact Person Email
- celine.mascaux@chru-strasbourg.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Pneumologie
- Principal Investigator Name
- Christos Chouaid
- Principal Investigator Email
- Christos.chouaid@chicreteil.fr
- Contact Person Name
- Christos Chouaid
- Contact Person Email
- Christos.chouaid@chicreteil.fr
- Site Name
- CHRU De Nancy
- Department Name
- Pneumology
- Principal Investigator Name
- Bertrand Mennecier
- Principal Investigator Email
- b.mennecier@chru-nancy.fr
- Contact Person Name
- Bertrand Mennecier
- Contact Person Email
- b.mennecier@chru-nancy.fr
- Site Name
- Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
- Department Name
- Service de pneumologie
- Principal Investigator Name
- Didier Debieuvre
- Principal Investigator Email
- debieuvred@ghrmsa.fr
- Contact Person Name
- Didier Debieuvre
- Contact Person Email
- debieuvred@ghrmsa.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Ludovic Doucet
- Principal Investigator Email
- Ludovic.doucet@ico.unicancer.fr
- Contact Person Name
- Ludovic Doucet
- Contact Person Email
- Ludovic.doucet@ico.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Hela SKHIRI
- Principal Investigator Email
- Hela.skhiri@chu-poitiers.fr
- Contact Person Name
- Hela SKHIRI
- Contact Person Email
- Hela.skhiri@chu-poitiers.fr
- Site Name
- Assistance Publique Hopitaux De Paris (multiple sites)
- Department Name
- Pneumologie / Chest department / Medical and Thoracic Oncology Department (various)
- Principal Investigator Name
- Various
- Contact Person Name
- Marie WISLEZ / Jacques CADRANEL / Boris Duchemann
- Contact Person Email
- Marie.wislez@aphp.fr / Jacques.cadranel@aphp.fr / boris.duchemann@aphp.fr
- Site Name
- Centre Hospitalier Departemental Vendee
- Department Name
- Pneumology
- Principal Investigator Name
- Cyril Guibert
- Principal Investigator Email
- cyril.guibert@ght85.fr
- Contact Person Name
- Cyril Guibert
- Contact Person Email
- cyril.guibert@ght85.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Respiratory diseases
- Principal Investigator Name
- Rémi Veillon
- Principal Investigator Email
- remi.veillon@chu-bordeaux.fr
- Contact Person Name
- Rémi Veillon
- Contact Person Email
- remi.veillon@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Limoges
- Department Name
- Pneumology UOT
- Principal Investigator Name
- Thomas Egenod
- Principal Investigator Email
- thomas.egenod@chu-limoges.fr
- Contact Person Name
- Thomas Egenod
- Contact Person Email
- thomas.egenod@chu-limoges.fr
Belgium
- Earliest CTIS Part Ii Submission Date
- 02-08-2024
- Latest Decision Or Authorization Date
- 12-03-2026
- Processing Time Days
- 587
- Number Of Sites
- 10
- Number Of Participants
- 35
Sites
- Site Name
- Algemeen Ziekenhuis Delta (Torhout)
- Department Name
- Pneumology
- Principal Investigator Name
- Ingel Demedts
- Principal Investigator Email
- ingel.demedts@azdelta.be
- Contact Person Name
- Ingel Demedts
- Contact Person Email
- ingel.demedts@azdelta.be
- Site Name
- Algemeen Ziekenhuis Klina
- Department Name
- Internal Diseases and Oncology
- Principal Investigator Name
- Wim Demey
- Principal Investigator Email
- wim.demey@klina.be
- Contact Person Name
- Wim Demey
- Contact Person Email
- wim.demey@klina.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Head and neck oncology center
- Principal Investigator Name
- Vincent Vanhaudenarde
- Principal Investigator Email
- vincent.vanhaudenarde@chuuclnamur.uclouvain.be
- Contact Person Name
- Vincent Vanhaudenarde
- Contact Person Email
- vincent.vanhaudenarde@chuuclnamur.uclouvain.be
- Site Name
- UZ Leuven
- Department Name
- Respiratory Oncology Unit – Dept. Respiratory Medicine
- Principal Investigator Name
- Els Wauters
- Principal Investigator Email
- els.wauters@uzleuven.be
- Contact Person Name
- Els Wauters
- Contact Person Email
- els.wauters@uzleuven.be
- Site Name
- Jessa Ziekenhuis
- Department Name
- Pneumology
- Principal Investigator Name
- Kristof Cuppens
- Principal Investigator Email
- kristof.cuppens@jessazh.be
- Contact Person Name
- Kristof Cuppens
- Contact Person Email
- kristof.cuppens@jessazh.be
- Site Name
- Az Maria Middelares Gent
- Department Name
- Pulmonary Medicine
- Principal Investigator Name
- Paul Germonpré
- Principal Investigator Email
- paul.germonpre@mijnziekenhuis.be
- Contact Person Name
- Paul Germonpré
- Contact Person Email
- paul.germonpre@mijnziekenhuis.be
- Site Name
- Algemeen Ziekenhuis Delta (Menen)
- Department Name
- Pneumology
- Principal Investigator Name
- Ingel Demedts
- Principal Investigator Email
- ingel.demedts@azdelta.be
- Contact Person Name
- Ingel Demedts
- Contact Person Email
- ingel.demedts@azdelta.be
- Site Name
- Algemeen Ziekenhuis Delta (Roeselare)
- Department Name
- Pneumology
- Principal Investigator Name
- Ingel Demedts
- Principal Investigator Email
- ingel.demedts@azdelta.be
- Contact Person Name
- Ingel Demedts
- Contact Person Email
- ingel.demedts@azdelta.be
- Site Name
- Algemeen Ziekenhuis Groeninge
- Department Name
- Respiratory Oncology / Pneumology
- Principal Investigator Name
- Katrien Ghysen
- Principal Investigator Email
- katrien.ghysen@azgroeninge.be
- Contact Person Name
- Katrien Ghysen
- Contact Person Email
- katrien.ghysen@azgroeninge.be
- Site Name
- Algemeen Ziekenhuis Delta (Brasschaat)
- Department Name
- Internal Diseases and Oncology
- Principal Investigator Name
- Wim Demey
- Principal Investigator Email
- wim.demey@klina.be
- Contact Person Name
- Wim Demey
- Contact Person Email
- wim.demey@klina.be
Sponsor
Primary sponsor
- Full Name
- OSE Immunotherapeutics
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Contract research organisations
- Name
- Icon Clinical Research Limited
- Name
- PRA Hellas CRO A.E.
Third parties
- {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"Testing facilities","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"France","full_name":"Eurofins Amatsigroup S.A.S.","duties_or_roles":"Packaging and Certification of the IMP","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Theradis Pharma","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Exystat","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Genome Diagnostics B.V.","duties_or_roles":"Manufacturer of the IVD","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Cenexi HSC","duties_or_roles":"Manufacturer of the IMP, IMP Testing","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Charles River Laboratories Evreux","duties_or_roles":"IMP Testing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient travel reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"France","full_name":"Stragen Services S.A.S.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Polypeptide Laboratories Inc.","duties_or_roles":"Manufacturer of the DS (IMP)","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Quipment","duties_or_roles":"Providing freezer and lab equipment for sites (if needed).","organisation_type":"Non-Pharmaceutical company"}
- {"country":"France","full_name":"AR2I Sa Analyses Recherches Et Innovation Instrumentale","duties_or_roles":"IMP Testing","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Eurofins Clinical Trial Supplies France","duties_or_roles":"Packaging and Certification of the IMP","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- TEDOPI (OSE2101)
- Active Substance
- MPS-112, MPS-106, MPS-213, MPS-102, MPS-216, MPS-103, MPS-215, MPS-214, D-ALA-LYS-CHA-VAL-ALA-ALA-TRP-THR-LEU-LYS-ALA-ALA-D-ALA, MPS-200
- Modality
- Vaccine
- Routes Of Administration
- Subcutaneous injection
- Route
- Subcutaneous injection
- Authorisation Status
- prodAuthStatus: 1
- Starting Dose
- not specified (maximum daily dose 5 mg listed)
- Maximum Dose
- 75 mg (max total dose amount as listed)
- Investigational Product Name
- DOCETAXEL
- Active Substance
- Docetaxel
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- prodAuthStatus: 2
- Starting Dose
- not specified (maximum daily dose 75 mg/m2 listed)
- Maximum Dose
- 2625 mg/m2 (max total dose amount as listed)
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