Clinical trial • Phase III • Oncology

BNT327 for Small cell lung cancer (extensive-stage)

Phase III trial of BNT327 for Small cell lung cancer (extensive-stage).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Small cell lung cancer (extensive-stage)
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme|Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
05-09-2025
First CTIS Authorization Date
22-12-2025

Trial design

Randomised, atezolizumab in combination with chemotherapy (etoposide + carboplatin) — comparator includes tecentriq (atezolizumab) (product record: atezolizumab; max daily dose recorded 1200 mg, intravenous infusion) plus chemotherapy agents etoposide (etoposide; max daily dose recorded 100 mg/m2, intravenous infusion) and carboplatin (carboplatin; max daily dose recorded 750 mg, intravenous infusion). other comparator agents listed: cisplatin (cisplatin; max daily dose recorded 80 mg/m2, intravenous infusion).-controlled Phase III trial in France, Italy, Spain and others.

Randomised
Yes
Comparator
Atezolizumab in combination with chemotherapy (etoposide + carboplatin) — comparator includes Tecentriq (atezolizumab) (product record: ATEZOLIZUMAB; max daily dose recorded 1200 mg, intravenous infusion) plus chemotherapy agents etoposide (ETOPOSIDE; max daily dose recorded 100 mg/m2, intravenous infusion) and carboplatin (CARBOPLATIN; max daily dose recorded 750 mg, intravenous infusion). Other comparator agents listed: cisplatin (CISPLATIN; max daily dose recorded 80 mg/m2, intravenous infusion).
Target Sample Size
455

Eligibility

Recruits 455 Vulnerable individuals are excluded: "Are vulnerable individuals as per ICH E6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate." Participants must be adults and able to provide written informed consent: "Are able to give informed consent and have given written consent in accordance with ICH GCP and local legislation prior to the start of any trial-specific procedures." (Minimum age criterion: "Are 18 years of age or older at the time of giving informed consent.").

Pregnancy Exclusion
Are pregnant or breastfeeding or are planning pregnancy or to father children during the trial or within 6 months after the last dose of IMP.
Vulnerable Population
Vulnerable individuals are excluded: "Are vulnerable individuals as per ICH E6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate." Participants must be adults and able to provide written informed consent: "Are able to give informed consent and have given written consent in accordance with ICH GCP and local legislation prior to the start of any trial-specific procedures." (Minimum age criterion: "Are 18 years of age or older at the time of giving informed consent.")

Inclusion criteria

  • {"criterion_text":"- Are able to give informed consent and have given written consent in accordance with ICH GCP and local legislation prior to the start of any trial-specific procedures.\n- Are participants of child-bearing potential (POCBP) who have a negative serum beta-human chorionic gonadotropin test at screening within 7 days of the first investigational medicinal product (IMP) dose.\n- Are POCBP who agree to practice a highly effective form of contraception starting at the Screening Visit and continuously until 6 months after receiving the last dose of trial treatment or 7 months after the last dose of cisplatin, whichever is later, if cisplatin is received at any point during the induction period.\n- Men who are sexually active with a partner born female and have not had a vasectomy who agree to use condoms and to ask their sexual partners, to practice a highly effective form of contraception during the trial, starting at the Screening Visit and continuously until 6 months after receiving the last dose of trial treatment or 7 months after the last dose of cisplatin, whichever is later, if cisplatin is received at any point during the induction period.\n- Agree not to donate and/or cryopreserve germ cells (sperm, oocytes, ova) for the purposes of assisted reproduction during trial, starting at screening and continuously until 6 months after the last dose of trial treatment or 7 months after the last dose of cisplatin, whichever is later, if cisplatin is received at any point during the induction period.\n- Are willing and able to comply with scheduled visits, treatment schedule, the planned trial assessments, laboratory tests, lifestyle restrictions, and other requirements of the trial. This includes that they are able to understand and follow trial-related instructions.\n- Are 18 years of age or older at the time of giving informed consent.\n- Have histologically or cytologically confirmed extensive-stage small-cell lung cancer (ES-SCLC).\n- Have not had prior systemic therapy for ES-SCLC.\n- Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.\n- ECOG performance status of 0 or 1.\n- Have a body weight of at least 40 kg.\n- Have adequate hematologic (coagulation) and organ function (liver, kidney)."}

Exclusion criteria

  • {"criterion_text":"- Are pregnant or breastfeeding or are planning pregnancy or to father children during the trial or within 6 months after the last dose of IMP.\n- Participants with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen test result at screening).\n- Have an active hepatitis C virus infection.\n- Have any of the heart conditions within 6 months prior to the trial treatment as specified in the study protocol.\n- Have hypertension or diabetic conditions prior to trial treatment as specified in the study protocol.\n- Have a medical, psychological, or social condition which, in the opinion of the investigator, could compromise their wellbeing if they participate in the trial, or that could prevent, limit, or confound the protocol-specified assessments or procedures, or that could impact adherence to protocol-described requirements.\n- Have histologically or cytologically confirmed small-cell lung cancer (SCLC) with combined histologies.\n- Have received any of the therapies or drugs within the time intervals prior to trial treatment as per study protocol.\n- Have undergone major organ surgery, have significant trauma, or invasive dental procedures within 21 days prior to the trial treatment or plan to undergo elective surgery during the trial.\n- Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.\n- Have any of the central nervous system metastases as described in the study protocol.\n- Have active autoimmune disease or history of autoimmune diseases with anticipated relapse, except for clinically stable autoimmune thyroid disease or Type-1 diabetes, or skin disorders including psoriasis, vitiligo, or alopecia.\n- Have adverse events (AEs) from prior antitumor therapy whose AE(s) have not returned to Grade 1 (graded by CTCAE 5.0 criteria) or below.\n- Have superior vena cava syndrome or symptoms of spinal cord compression that requires urgent medical intervention.\n- Have active, or a history of, pneumonitis requiring treatment with steroids, or has active, or a history of, interstitial lung disease.\n- Have active tuberculosis or have active syphilis infection.\n- Have an underlying condition that may increase the risk of the combination treatment or complicate the interpretation of AEs, as judged by the investigator, or other scenarios that the investigators consider the participant is not eligible for the trial.\n- Are vulnerable individuals as per ICH E6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.\n- Have had other malignant tumors within 3 years prior to the trial treatment.\n- Have serious non-healing wounds or serious bone fractures.\n- Have significant risks of hemorrhage as defined in the study protocol.\n- Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.\n- Have a history of serious Grade 3 or higher immune-related adverse events (irAEs) that led to treatment discontinuation of a prior immunotherapy.\n- Have a known or suspected hypersensitivity to the trial treatments including any active ingredient or excipients thereof.\n- Have a known human immunodeficiency virus infection or known acquired immunodeficiency syndrome."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall survival (OS) defined as the time from randomization to death from any cause.","definition_or_measurement_approach":"Defined as the time from randomization to death from any cause."}

Secondary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS) defined as the time from randomization to first objective tumor progression, or death from any cause, whichever occurs first.","definition_or_measurement_approach":"Defined as the time from randomization to first objective tumor progression, or death from any cause, whichever occurs first."}
  • {"endpoint_text":"- Objective response rate (ORR) defined as the proportion of participants in whom a complete response (CR) or partial response (PR) is observed as best overall response with confirmation.","definition_or_measurement_approach":"Proportion of participants with confirmed complete response (CR) or partial response (PR) as best overall response."}
  • {"endpoint_text":"- Duration of response (DOR) defined as the time from onset of objective response (confirmed CR or PR based on investigator’s assessment) to first occurrence of objective tumor progression (progressive disease) or death from any cause, whichever occurs first.","definition_or_measurement_approach":"Time from onset of confirmed objective response (CR or PR per investigator) to first objective tumor progression or death, whichever occurs first."}
  • {"endpoint_text":"- Progression-free survival (PFS) rate based on investigator’s assessment at 6, 12, and 18 months.","definition_or_measurement_approach":"PFS rate at fixed timepoints (6, 12, 18 months) as assessed by investigator per RECIST v1.1."}
  • {"endpoint_text":"- Overall survival (OS) rate at 6, 12, 18, and 24 months.","definition_or_measurement_approach":"OS rate at fixed timepoints (6, 12, 18, 24 months)."}
  • {"endpoint_text":"- Occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs, by relationship.","definition_or_measurement_approach":"Incidence of TEAEs including Grade ≥3, serious, and fatal TEAEs, categorized by relationship to study treatment."}
  • {"endpoint_text":"- Occurrence of dose delay, infusion interruption, and discontinuation of study treatment due to TEAEs (including related TEAEs)","definition_or_measurement_approach":"Incidence of dose delays, infusion interruptions, and discontinuations due to TEAEs (including related TEAEs)."}
  • {"endpoint_text":"- Change from baseline in EORTC QLQ-C30 Global Health status / Quality-of-Life score (Items 29 and 30).","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 Global Health Status / QoL (items 29 and 30)."}
  • {"endpoint_text":"- Change from baseline in EORTC QLQ-C30 physical functioning","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 physical functioning domain score."}
  • {"endpoint_text":"- Change from baseline in coughing scale of the EORTC quality-of-life-Lung cancer 29 questionnaire (QLQ-LC29).","definition_or_measurement_approach":"Change from baseline in QLQ-LC29 cough scale."}
  • {"endpoint_text":"- Change from baseline in shortness of breath scale of the EORTC QLQ-LC29.","definition_or_measurement_approach":"Change from baseline in QLQ-LC29 shortness of breath scale."}
  • {"endpoint_text":"- Change from baseline in \"coughed up blood item\" of the EORTC QLQ-LC29","definition_or_measurement_approach":"Change from baseline in QLQ-LC29 item assessing coughed up blood."}
  • {"endpoint_text":"- Change from baseline in the Functional Assessment of Cancer Therapy overall bother item (FACT-GP5).","definition_or_measurement_approach":"Change from baseline in FACT-GP5 'overall bother' item."}

Recruitment

Planned Sample Size
455
Recruitment Window Months
35
Consent Approach
Participants must be able to provide written informed consent: "Are able to give informed consent and have given written consent in accordance with ICH GCP and local legislation prior to the start of any trial-specific procedures." Minimum age is 18 years. Subject information and informed consent forms (L1/L2 SIS-ICF and related documents) are provided; country/language-specific ICFs are included (documents and synopses available in English, Dutch, French, German, Italian, Spanish, Polish, Romanian as indicated by document translations and country-specific ICF files). No assent for minors is provided because enrollment requires age ≥18.

Geography

Total Number Of Sites
75
Total Number Of Participants
249

France

Earliest CTIS Part Ii Submission Date
02-12-2025
Latest Decision Or Authorization Date
24-12-2025
Processing Time Days
22
Number Of Sites
7
Number Of Participants
18

Sites

Site Name
Institut Curie
Department Name
Service de Pneumologie
Principal Investigator Name
Nicolas Girard
Principal Investigator Email
nicolas.girard2@curie.fr
Contact Person Name
Nicolas Girard
Contact Person Email
nicolas.girard2@curie.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Service de Pneumologie et d’Oncologie Thoracique
Principal Investigator Name
Simon Deshayes
Principal Investigator Email
deshayes-si@chu-caen.fr
Contact Person Name
Simon Deshayes
Contact Person Email
deshayes-si@chu-caen.fr
Site Name
Institut Bergonie
Department Name
Oncologie Médicale
Principal Investigator Name
Sophie Cousin
Principal Investigator Email
s.cousin@bordeaux.unicancer.fr
Contact Person Name
Sophie Cousin
Contact Person Email
s.cousin@bordeaux.unicancer.fr
Site Name
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
Department Name
Service Pneumologie
Principal Investigator Name
Clarisse Audigier-Valette
Principal Investigator Email
clarisse.audigier-valette@ch-toulon.fr
Contact Person Name
Clarisse Audigier-Valette
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service de Pneumologie
Principal Investigator Name
Charles Ricordel
Principal Investigator Email
charles.ricordel@chu-rennes.fr
Contact Person Name
Charles Ricordel
Contact Person Email
charles.ricordel@chu-rennes.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie Medicale
Principal Investigator Name
Sandrine Hiret
Principal Investigator Email
sandrine.hiret@ico.unicancer.fr
Contact Person Name
Sandrine Hiret
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Service de Pneumologie
Principal Investigator Name
Youssef Oulkhouir
Principal Investigator Email
youssef.oulkhouir@chu-angers.fr
Contact Person Name
Youssef Oulkhouir

Italy

Earliest CTIS Part Ii Submission Date
03-12-2025
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
19
Number Of Sites
8
Number Of Participants
20

Sites

Site Name
Azienda Socio Sanitaria Territoriale Di Cremona
Department Name
SC Medical Oncology
Principal Investigator Name
Stefano Panni
Principal Investigator Email
stefano.panni@asst-cremona.it
Contact Person Name
Stefano Panni
Contact Person Email
stefano.panni@asst-cremona.it
Site Name
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
Department Name
UOC Oncologia Medica - Ospedale San Luca
Principal Investigator Name
Edi Editta Baldini
Principal Investigator Email
editta.baldini@uslnordovest.toscana.it
Contact Person Name
Edi Editta Baldini
Site Name
Azienda Ospedaliera Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
UOC Oncoematologia
Principal Investigator Name
Floriana Morgillo
Principal Investigator Email
floriana.morgillo@unicampania.it
Contact Person Name
Floriana Morgillo
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
SOC Oncologia Medica e dei Tumori Immunocorrelati
Principal Investigator Name
Alessandra Bearz
Principal Investigator Email
abearz@cro.it
Contact Person Name
Alessandra Bearz
Contact Person Email
abearz@cro.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
UOC Oncologia Medica
Principal Investigator Name
Diego Luigi Cortinovis
Principal Investigator Email
diegoluigi.cortinovis@irccs-sangerardo.it
Contact Person Name
Diego Luigi Cortinovis
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
S.S.D. 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
AORN San Giuseppe Moscati Avellino
Department Name
Dipartimento di Oncologia
Principal Investigator Name
Cesare Gridelli
Principal Investigator Email
cegridelli@aosgmoscati.av.it
Contact Person Name
Cesare Gridelli
Contact Person Email
cegridelli@aosgmoscati.av.it
Site Name
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.
Department Name
UO Oncologia Toracica, Lung Unit
Principal Investigator Name
Antonio Santo
Principal Investigator Email
antonio.santo@ospedale.pederzoli.it
Contact Person Name
Antonio Santo

Spain

Earliest CTIS Part Ii Submission Date
27-11-2025
Latest Decision Or Authorization Date
18-02-2026
Processing Time Days
83
Number Of Sites
15
Number Of Participants
30

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Pedro Filipe Simões da Rocha
Principal Investigator Email
pedrorocha@vhio.net
Contact Person Name
Pedro Filipe Simões da Rocha
Contact Person Email
pedrorocha@vhio.net
Site Name
Hospital Universitario De Leon
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Soledad Medina Valdivieso
Principal Investigator Email
soledadmedina@saludcastillayleon.es
Contact Person Name
Soledad Medina Valdivieso
Site Name
Hospital Universitario De Badajoz
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Marta González Cordero
Principal Investigator Email
marta.gonzalezc@salud-juntaex.es
Contact Person Name
Marta González Cordero
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Servicio de Oncología
Principal Investigator Name
Oscar José Juan Vidal
Principal Investigator Email
juan_osc@gva.es
Contact Person Name
Oscar José Juan Vidal
Contact Person Email
juan_osc@gva.es
Site Name
Consorcio Hospitalario Provincial De Castellon
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Alfredo Sánchez Hernández
Principal Investigator Email
asanchezh@seom.org
Contact Person Name
Alfredo Sánchez Hernández
Contact Person Email
asanchezh@seom.org
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Servicio de Oncología
Principal Investigator Name
David Vicente Baz
Principal Investigator Email
david.vicente.sspa@juntadeandalucia.es
Contact Person Name
David Vicente Baz
Site Name
Hospital Alvaro Cunqueiro
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Cristina Azpitarte Raposeiras
Principal Investigator Email
cristina.azpitarte.raposeiras@sergas.es
Contact Person Name
Cristina Azpitarte Raposeiras
Site Name
Hospital Del Mar
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Edurne Arriola Aperribay
Principal Investigator Email
earriola@parcdesalutmar.cat
Contact Person Name
Edurne Arriola Aperribay
Contact Person Email
earriola@parcdesalutmar.cat
Site Name
MD Anderson Cancer Center
Department Name
Unidad de ensayos clínicos
Principal Investigator Name
Fernando Fabio Franco Pérez
Principal Investigator Email
ffranco@fundacionmdanderson.es
Contact Person Name
Fernando Fabio Franco Pérez
Contact Person Email
ffranco@fundacionmdanderson.es
Site Name
Hospital Universitario Virgen De Valme
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Jose Fuentes Pradera
Contact Person Name
Jose Fuentes Pradera
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Unidad de ensayos clínicos
Principal Investigator Name
Fernando Fabio Franco Pérez
Principal Investigator Email
ffranco@fundacionmdanderson.es
Contact Person Name
Fernando Fabio Franco Pérez
Contact Person Email
ffranco@fundacionmdanderson.es
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Maria Dolores Isla Casado
Principal Investigator Email
disla@salud.aragon.es
Contact Person Name
Maria Dolores Isla Casado
Contact Person Email
disla@salud.aragon.es
Site Name
Micancer Center S.L.P.
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Santiago Viteri Ramirez
Principal Investigator Email
sviteri@uomi.es
Contact Person Name
Santiago Viteri Ramirez
Contact Person Email
sviteri@uomi.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Vanesa Gutierrez Calderon
Principal Investigator Email
vgutierrezcald@gmail.com
Contact Person Name
Vanesa Gutierrez Calderon
Contact Person Email
vgutierrezcald@gmail.com
Site Name
Hospital Universitario De Torrejon
Department Name
Servicio de Oncología Médica
Principal Investigator Name
Luis Cabezon Gutierrez
Principal Investigator Email
lcabezon@torrejonsalud.com
Contact Person Name
Luis Cabezon Gutierrez
Contact Person Email
lcabezon@torrejonsalud.com

Germany

Earliest CTIS Part Ii Submission Date
25-11-2025
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
83
Number Of Sites
19
Number Of Participants
38

Sites

Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Medizinische Klinik III
Principal Investigator Name
Sabine Bohnet
Contact Person Name
Sabine Bohnet
Site Name
MVZ Johanniter Onkologie Bonn-RheinSieg, Johanniter-MVZ Bonn GmbH
Principal Investigator Name
Folke Lohse
Principal Investigator Email
folke.lohse@bn.johanniter-mvz.de
Contact Person Name
Folke Lohse
Site Name
Muenchen Klinik gGmbH
Department Name
Klinik für Pneumologie und Pneumologische Onkologie
Principal Investigator Name
Konrad Kokowski
Principal Investigator Email
konrad.kokowski@muenchen-klinik.de
Contact Person Name
Konrad Kokowski
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Fächerverbund für Infektologie, Pneumologie und Intensivmedizin
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
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Department Name
Klinik fuer Innere Medizin II
Principal Investigator Name
Miriam Moeller
Principal Investigator Email
studiensekretariat.halle@marthamaria.de
Contact Person Name
Miriam Moeller
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Medizinische Klinik IV Klinik für Onkologie, Hämatologie und Stammzelltransplantation
Principal Investigator Name
Martin Kirschner
Principal Investigator Email
mkirschner@ukaachen.de
Contact Person Name
Martin Kirschner
Contact Person Email
mkirschner@ukaachen.de
Site Name
Kaiserswerther Diakonie
Department Name
Florance Nightingale Krankenhaus
Principal Investigator Name
Stefan Krueger
Principal Investigator Email
stkrueger@kaiserswerther-diakonie.de
Contact Person Name
Stefan Krueger
Site Name
Klinikverbund Allgaeu gGmbH
Department Name
Klinikum Kempten / MVZ Pneumologie im AeH
Principal Investigator Name
Christian Schumann
Contact Person Name
Christian Schumann
Site Name
Klinikum Nuernberg
Department Name
Department of Internal Medicine 3
Principal Investigator Name
Markus Horneber
Contact Person Name
Markus Horneber
Site Name
MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH
Principal Investigator Name
Lars Galonska
Principal Investigator Email
info@onko-neuss.de
Contact Person Name
Lars Galonska
Contact Person Email
info@onko-neuss.de
Site Name
SRH Wald-Klinikum Gera GmbH
Department Name
Zentrum für klinische Studien
Principal Investigator Name
Dagmar Täuscher
Principal Investigator Email
taeuscher.studienzentrum.wkg@srh.de
Contact Person Name
Dagmar Täuscher
Site Name
Helios Universitaetsklinikum Wuppertal
Department Name
Klinik für Hämatologie, Onkologie, klinische Infektiologie und Palliativmedizin
Principal Investigator Name
Oliver Schmalz
Principal Investigator Email
oliver.schmalz@helios-gesundheit.de
Contact Person Name
Oliver Schmalz
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Klinik für Pneumologie
Principal Investigator Name
Jürgen Alt
Principal Investigator Email
juergen.alt@unimedizin-mainz.de
Contact Person Name
Jürgen Alt
Site Name
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
Department Name
Klinik für Pneumologie
Principal Investigator Name
Christian Grohe
Principal Investigator Email
pneumologie.lungenklinik@jsd.de
Contact Person Name
Christian Grohe
Site Name
Asklepios Klinik Gauting GmbH
Department Name
Zentrum für Pneumologie und Thoraxchirurgie
Principal Investigator Name
Niels Reinmuth
Principal Investigator Email
studien.gauting@asklepios.com
Contact Person Name
Niels Reinmuth
Contact Person Email
studien.gauting@asklepios.com
Site Name
Klinikum Esslingen GmbH
Department Name
Klinik für Kardiologie, Angiologie und Pneumologie
Principal Investigator Name
Martin Faehling
Principal Investigator Email
m.faehling@klinikum-esslingen.de
Contact Person Name
Martin Faehling
Site Name
LungenClinic Grosshansdorf GmbH
Department Name
Onkologie
Principal Investigator Name
Martin Reck
Principal Investigator Email
k.hundhausen@lungenclinic.de
Contact Person Name
Martin Reck
Contact Person Email
k.hundhausen@lungenclinic.de
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinik für Innere Medizin IV
Principal Investigator Name
Stefan Hammerschmidt
Principal Investigator Email
s.hammerschmidt@skc.de
Contact Person Name
Stefan Hammerschmidt
Contact Person Email
s.hammerschmidt@skc.de
Site Name
Medical Center - University Of Freiburg
Department Name
Department of Internal Medicine I, Hematology, Oncology und Stem Cell Transplantation
Principal Investigator Name
Cornelius Waller
Principal Investigator Email
Cornelius.waller@uniklinik-freiburg.de
Contact Person Name
Cornelius Waller

Poland

Earliest CTIS Part Ii Submission Date
25-11-2025
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
91
Number Of Sites
16
Number Of Participants
100

Sites

Site Name
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Centrum Innowacyjnych Terapii
Principal Investigator Name
Izabela Chmielewska
Principal Investigator Email
cwbk@umlub.pl
Contact Person Name
Izabela Chmielewska
Contact Person Email
cwbk@umlub.pl
Site Name
Uniwersyteckie Centrum Kliniczne (Gdansk)
Department Name
Klinika Onkologii i Radioterapii
Principal Investigator Name
Marcin Skrzypski
Principal Investigator Email
info@uck.gda.pl
Contact Person Name
Marcin Skrzypski
Contact Person Email
info@uck.gda.pl
Site Name
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
Department Name
Oddział Onkologii z Pododdziałem Chemioterapii
Principal Investigator Name
Andrzej Każarnowicz
Principal Investigator Email
sekretariat@wmccp.pl
Contact Person Name
Andrzej Każarnowicz
Contact Person Email
sekretariat@wmccp.pl
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
II Klinika Chrób Płuc, Raka Płuca i Chorób Wewnętrznych
Principal Investigator Name
Robert Mróz
Principal Investigator Email
pulmonolog2@uskwb.pl
Contact Person Name
Robert Mróz
Contact Person Email
pulmonolog2@uskwb.pl
Site Name
PRZYCHODNIA LEKARSKA ”KOMED” ROMAN KARASZEWSKI
Department Name
PRZYCHODNIA LEKARSKA ”KOMED”
Principal Investigator Name
Bogusława Karaszewska
Principal Investigator Email
komed.badania@gmail.com
Contact Person Name
Bogusława Karaszewska
Contact Person Email
komed.badania@gmail.com
Site Name
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Department Name
Oddział Onkologiczny Z Pododdziałem Dziennej Chemioterapii
Principal Investigator Name
Kamil Kuć
Principal Investigator Email
kkuc@wszp.pl
Contact Person Name
Kamil Kuć
Contact Person Email
kkuc@wszp.pl
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Onkologii Klinicznej z Pododziałem Chemioterapii Jednodniowej
Principal Investigator Name
Mariusz Kwiatkowski
Principal Investigator Email
sekretariat.odch@swk.med.pl
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
sekretariat.odch@swk.med.pl
Site Name
Futuremeds Sp. z o.o.
Department Name
FutureMeds Kraków
Principal Investigator Name
Michał Parkitny
Principal Investigator Email
michal.parkitny@futuremeds.com
Contact Person Name
Michał Parkitny
Contact Person Email
michal.parkitny@futuremeds.com
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotowrów Płuca i Klatki Piersiowej
Principal Investigator Name
Adam Płużański
Principal Investigator Email
paulina.kukwa@nio.gov.pl
Contact Person Name
Adam Płużański
Contact Person Email
paulina.kukwa@nio.gov.pl
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
Poradnia Onkologiczna CWBK
Principal Investigator Name
Wojciech Solarek
Principal Investigator Email
badaniakliniczne@wim.mil.pl
Contact Person Name
Wojciech Solarek
Contact Person Email
badaniakliniczne@wim.mil.pl
Site Name
Pratia S.A. (Wroclaw)
Department Name
Pratia Onkologia Wrocław
Principal Investigator Name
Bożena Cybulska-Stopa
Principal Investigator Email
biuro.onkologia.wroclaw@pratia.com
Contact Person Name
Bożena Cybulska-Stopa
Site Name
Pratia S.A. (Poznan)
Department Name
Pratia Poznań
Principal Investigator Name
Marek Kotlarski
Principal Investigator Email
marek.kotlarski@pratia.com
Contact Person Name
Marek Kotlarski
Contact Person Email
marek.kotlarski@pratia.com
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddział Chorób Rozrostowych
Principal Investigator Name
Maja Lisik-Habib
Principal Investigator Email
badania.kliniczne@kopernik.lodz.pl
Contact Person Name
Maja Lisik-Habib
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
Katowickie Centrum Onkologii
Department Name
Oddział Onkologiczny
Principal Investigator Name
Magdalena Zajdel-Stachoń
Principal Investigator Email
biuro@m2m-badania.pl
Contact Person Name
Magdalena Zajdel-Stachoń
Contact Person Email
biuro@m2m-badania.pl
Site Name
Pratia Hematologia Sp. z o.o.
Department Name
Pratia Onkologia Katowice
Principal Investigator Name
Kamil Wdowiak
Principal Investigator Email
kontakt.onkologia.katowice@pratia.com
Contact Person Name
Kamil Wdowiak

Romania

Earliest CTIS Part Ii Submission Date
20-03-2026
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
28
Number Of Sites
9
Number Of Participants
31

Sites

Site Name
Spitalul Clinic Coltea
Department Name
Medical Oncology
Principal Investigator Name
Raluca Ileana Patru
Principal Investigator Email
raluca.patru@gmail.com
Contact Person Name
Raluca Ileana Patru
Contact Person Email
raluca.patru@gmail.com
Site Name
Cardiomed S.R.L.
Department Name
Medical Oncology
Principal Investigator Name
Calin Ioan Cainap
Principal Investigator Email
calin.cainap@cardiomedcluj.ro
Contact Person Name
Calin Ioan Cainap
Contact Person Email
calin.cainap@cardiomedcluj.ro
Site Name
Oncomed S.R.L.
Department Name
Medical Oncology
Principal Investigator Name
Mihaela-Maria Pasca-Fenesan
Principal Investigator Email
fenesan.mihaela@gmail.com
Contact Person Name
Mihaela-Maria Pasca-Fenesan
Contact Person Email
fenesan.mihaela@gmail.com
Site Name
Oncocenter Oncologie Clinica S.R.L.
Department Name
Oncology Clinique
Principal Investigator Name
Roxana Ioana Scheusan
Principal Investigator Email
roxana.scheusan@oncocenter.ro
Contact Person Name
Roxana Ioana Scheusan
Contact Person Email
roxana.scheusan@oncocenter.ro
Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
Medical Oncology II
Principal Investigator Name
Aurelia Alexandru
Principal Investigator Email
auralexandru@yahoo.com
Contact Person Name
Aurelia Alexandru
Contact Person Email
auralexandru@yahoo.com
Site Name
Centrul De Oncologie-Euroclinic S.R.L.
Department Name
Oncology
Principal Investigator Name
Constantin Volovat
Principal Investigator Email
cvolovat@gmail.com
Contact Person Name
Constantin Volovat
Contact Person Email
cvolovat@gmail.com
Site Name
Oncopremium Team S.R.L.
Department Name
Medical Oncology
Principal Investigator Name
Alina Amalia Herzal
Principal Investigator Email
oncopremiumteam@gmail.com
Contact Person Name
Alina Amalia Herzal
Contact Person Email
oncopremiumteam@gmail.com
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Medical 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
Spitalul Municipal Onesti Sf. Ierarh Luca
Department Name
Medical Oncology
Principal Investigator Name
Iuliu Ion Ionas
Principal Investigator Email
ionasiiuliu@yahoo.com
Contact Person Name
Iuliu Ion Ionas
Contact Person Email
ionasiiuliu@yahoo.com

Netherlands

Earliest CTIS Part Ii Submission Date
13-03-2026
Latest Decision Or Authorization Date
16-04-2026
Processing Time Days
34
Number Of Sites
1
Number Of Participants
12

Sites

Site Name
Jeroen Bosch Ziekenhuis Stichting
Department Name
Pulmonology
Principal Investigator Name
Bianca van Veggel
Principal Investigator Email
trialonclong@jbz.nl
Contact Person Name
Bianca van Veggel
Contact Person Email
trialonclong@jbz.nl

Sponsor

Primary sponsor

Full Name
BioNTech SE
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
4g Clinical LLC
Responsibilities
sponsorDuties codes: [3]
Name
Icon Clinical Research Limited
Responsibilities
sponsorDuties codes: [1,12,2,5]

Third parties

  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Pharma Services Limited","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"sponsorDuties codes: [15]; Pharmacokinetics, ADA detection and measurement","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"sponsorDuties codes: [15]; Long-term sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1,12,2,5]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
BNT327
Active Substance
BNT327
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Not authorised (prodAuthStatus:1)
Maximum Dose
1500 mg
Investigational Product Name
Tecentriq 1 200 mg concentrate for solution for infusion
Active Substance
Atezolizumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
Authorised (prodAuthStatus:2; marketingAuthNumber: EU/1/17/1220/001)
Maximum Dose
1200 mg
Investigational Product Name
CISPLATIN
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
Authorised (prodAuthStatus:2)
Maximum Dose
80 mg/m2
Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
Authorised (prodAuthStatus:2)
Maximum Dose
750 mg
Investigational Product Name
ETOPOSIDE
Active Substance
ETOPOSIDE
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
Authorised (prodAuthStatus:2)
Maximum Dose
100 mg/m2
Combination Treatment
Yes

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