Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer
A Phase II/III, Multisite, Randomized Master Protocol for a Global Trial of BNT327 in Combination With Chemotherapy and Other Investigational Agents in First-line Non-small Cell Lung Cancer
2 other identifiers
interventional
1,260
15 countries
206
Brief Summary
This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC). This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Jan 2025
Longer than P75 for phase_2 nonsmall-cell-lung-cancer
206 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2024
CompletedFirst Posted
Study publicly available on registry
December 2, 2024
CompletedStudy Start
First participant enrolled
January 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
April 15, 2026
April 1, 2026
4.1 years
November 11, 2024
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Phase 2 - Occurrence of treatment-emergent adverse events (TEAE) (including Grade ≥3), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-emergent serious adverse events (SAE), and treatment-related treatment emergent SAEs
For substudies A and B. AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0) in the combination treatment regimen.
From the first dose of the investigational medicinal product (IMP) to the 90-day Follow-Up Visit
Phase 2 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs)
For substudies A and B.
From the first dose of IMP to the 90-day Follow-Up Visit
Phase 2 - Objective response rate (ORR)
For substudies A and B. ORR is defined as the proportion of participants in whom a confirmed complete response (CR) or confirmed partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] based on the investigator's assessment) is observed as best overall response.
Up to approximately 2 years
Phase 2 - Best percentage change from baseline in tumor size
For substudies A and B. Based on investigator's tumor assessment according to RECIST v1.1.
Up to approximately 2 years
Phase 3 - Progression free survival (PFS) assessed by blinded independent central review (BICR)
For substudies A and B. PFS defined as the time from randomization to first documented tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first.
Up to approximately 5 years
Secondary Outcomes (18)
Phase 3 - Overall survival (OS)
Up to approximately 5 years
Phase 2 - Duration of Response (DOR)
Up to approximately 2 years
Phase 2 - Disease Control Rate (DCR)
Up to approximately 2 years
Phase 3 - PFS assessed by investigator
Up to approximately 5 years
Phase 3 - ORR
Up to approximately 2 years
- +13 more secondary outcomes
Study Arms (8)
Substudy A Phase 2 - Pumitamig Dose 1 + Carboplatin + Pemetrexed
EXPERIMENTALSubstudy A Phase 2 - Pumitamig Dose 2 + Carboplatin + Pemetrexed
EXPERIMENTALSubstudy A Phase 3 - Pumitamig + Carboplatin + Pemetrexed
EXPERIMENTALPumitamig dose 3 for Phase 3
Substudy A Phase 3 - Pembrolizumab + Carboplatin + Pemetrexed
ACTIVE COMPARATORSubstudy B Phase 2 - Pumitamig Dose 1 + Carboplatin + Paclitaxel
EXPERIMENTALSubstudy B Phase 2 - Pumitamig Dose 2 + Carboplatin + Paclitaxel
EXPERIMENTALSubstudy B Phase 3 - Pumitamig + Carboplatin + Paclitaxel
EXPERIMENTALPumitamig dose 3 for Phase 3
Substudy B Phase 3 - Pembrolizumab + Carboplatin + Paclitaxel
ACTIVE COMPARATORInterventions
Intravenous infusion
Intravenous infusion
Intravenous infusion
Intravenous infusion
Intravenous infusion
Eligibility Criteria
You may qualify if:
- Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 9th edition.
- Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Adequate organ function.
You may not qualify if:
- Have histologically or cytologically confirmed NSCLC with small-cell lung cancer histologic or neuroendocrine component.
- Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
- Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neo-adjuvant/adjuvant or locally advanced/metastatic setting.
- Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody
- Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\<=7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.
- Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.
- Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing fistula/perforation.
- Participants with significant risk of hemorrhage (per investigator clinical judgment).
- Have superior vena cava syndrome or symptoms of spinal cord compression.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioNTech SElead
- Bristol-Myers Squibbcollaborator
Study Sites (206)
Alaska Oncology and Hematology, LLC
Anchorage, Alaska, 99508, United States
John Muir Clinical Research Center
Concord, California, 94520, United States
University Of California - San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Clermont Oncology Center
Clermont, Florida, 34711, United States
Cleveland Clinic Florida - Martin North Hospital
Stuart, Florida, 34994, United States
H. Lee Moffit Cancer center and research institute
Tampa, Florida, 33612, United States
Cleveland Clinic Weston Hospital
Weston, Florida, 33331, United States
Physicians Clinic of Iowa
Cedar Rapids, Iowa, 52401-2112, United States
Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Baptist Health Hardin
Elizabethtown, Kentucky, 42701, United States
Frederick Health Hospital- James M Stockman Cancer Institute
Frederick, Maryland, 21704, United States
SSM Health Cancer Care - St. Clare
Fenton, Missouri, 63026, United States
Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC)
Hastings, Nebraska, 68901-4470, United States
Astera Cancer Care
East Brunswick, New Jersey, 08816, United States
Summit Medical Group PA
Florham Park, New Jersey, 07932, United States
The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion
Paramus, New Jersey, 07652, United States
Suny-Stony Brook University Cancer Center
Stony Brook, New York, 11794-9446, United States
White Plains Hospital
White Plains, New York, 10601, United States
Fletcher Hospital, Inc. dba AdventHealth Hendersonville
Hendersonville, North Carolina, 28792, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
The Christ Hospital Cancer Center
Cincinnati, Ohio, 45219, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion
Cleveland, Ohio, 44111, United States
Cleveland Clinic
Cleveland, Ohio, 44195-0001, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio, 44124, United States
INTEGRIS Cancer Institute of Oklahoma
Oklahoma City, Oklahoma, 73109, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Baptist Cancer Center
Memphis, Tennessee, 38120, United States
Millennium Research and Clinical Development, LLC
Houston, Texas, 77090, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
VCU Massey Cancer Center
Richmond, Virginia, 23298, United States
Cancer Research SA (CRSA)
Adelaide, 5000, Australia
Royal Adelaide Hospital
Adelaide, 5000, Australia
Flinders Medical Centre
Bedford Park, 5042, Australia
Cairns Hospital
Cairns, 4870, Australia
Dubbo Hospital
Dubbo, 2830, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, 3199, Australia
Icon Cancer Centre Kurralta Park
Kurralta Park, 5037, Australia
Peter MacCallum Cancer Centre
Melbourne, 3000, Australia
Monash University - Monash Health -Monash Medical Centre
Melbourne, 3168, Australia
Central West Cancer Care Centre
Orange, 2800, Australia
Western Health Sunshine Hospital
St Albans, 3021, Australia
ICON Cancer Care - Townsville
Townsville, 4812, Australia
Cancer Care Wollongong Pty Limited
Wollongong, 2500, Australia
Universitair Ziekenhuis Leuven
Leuven, 3000, Belgium
CHU HELORA, Hopital de Mons - Site Kennedy
Mons, 7000, Belgium
VITAZ
Sint-Niklaas, 9100, Belgium
Affiliated Hospital of Hebei University
Baoding, 071000, China
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050, China
Jilin Cancer Hospital
Changchun, 130000, China
Zhejiang Medical University, Zhejiang Cancer Hospital
Hangzhou, 310022, China
Shandong University - Jinan Central Hospital
Jinan, 250013, China
Yunnan Provincial Cancer Hospital
Kunming, 650118, China
Jiangsu Peoples Hospital
Nanjing, 210029, China
Shanghai Chest Hospital
Shanghai, 200030, China
Cancer Hospital of Shantou University Medical College
Shantou, 515041, China
The First Affiliated Hospital of Soochow University
Suzhou, 215006, China
Chongqing University Three Gorges Hospital
Wanzhou, 404000, China
Zhongnan Hospital of Wuhan University
Wuhan, 430071, China
Northern Jiangsu Peoples Hospital (NJPH)
Yangzhou, 225001, China
Taizhou Hospital of Zhejiang Province
Zhejiang, 317000, China
Centre Hospitalier Universitaire d'Angers (CHU Angers)
Angers, 49933, France
Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, 33076, France
CHU Caen Normandie
Caen, 14033, France
Centre Francois Baclesse
Caen, 14076, France
Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.)
Créteil, 94010, France
Institut Paoli-Calmettes
Marseille, 13009, France
Institut Curie - Centre de Recherche
Paris, 75005, France
CHU de Rennes, Hopital de Pontchaillou
Rennes, 35033, France
Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau
Saint-Herblain, 44805, France
Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre
Toulon, 83000, France
Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP
Villejuif, 94805, France
Uniklinik RWTH Aachen Medizinische Klinik IV
Aachen, 52074, Germany
Evangelische Lungenklinik Berlin
Berlin, 13125, Germany
Klinikum Chemnitz gGmbH
Chemnitz, 09116, Germany
Universitätsklinikum Erlangen
Erlangen, 91054, Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730, Germany
Asklepios Fachkliniken Muenchen Gauting
Gauting, 82131, Germany
SRH Wald-Kliniken Gera GmbH
Gera, 07548, Germany
Thoraxklinik-Heidelberg Ggmbh
Heidelberg, 69126, Germany
Lungenfachklinik Immenhausen - Pneumologische Lehrklinik der Universitaet Goettingen
Immenhausen, 34376, Germany
University Medical Center of Johannes Gutenberg-University Mainz
Mainz, 55131, Germany
MVZ for oncology and hematology Rhein-Kreis Neuss GmbH
Neuss, 41462, Germany
Onkologische Tagesklinik Remscheid
Remscheid, 42853, Germany
Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
Wesseling, 50389, Germany
Helios Klinikum Wuppertal-Universitaet Witten-Herdecke
Wuppertal, 42883, Germany
Azienda Ospedaliera San Giuseppe Moscati
Avellino, 83100, Italy
Centro di Riferimento Oncologico
Aviano, 33081, Italy
Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi
Bologna, 40138, Italy
Azienda Socio Sanitaria Territoriale di Cremona (ASST Cremona)
Cremona, 26100, Italy
Ospedale San Luca
Lucca, 55100, Italy
IRCCS Istituto Romagnolo per lo studio dei Tumori Dino Amadori (IRST)
Meldola, 47014, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Milan, 20132, Italy
UOC Oncoematologia AOU Luigi Vanvitelli
Naples, 80131, Italy
Casa Di Cura Polispecialistica Dott Pederzoli
Peschiera del Garda, 37019, Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, 00128, Italy
Istituti di Ricovero e Cura A Carattere Scientifico (IRCCS) - Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE)
Roma, 00144, Italy
Fondazione Ospedale Isola Tiberina - Gemelli Isola
Rome, 00186, Italy
Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
Siena, 53100, Italy
Ageo Central General Hospital
Ageo, 362-8588, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyō City, 113-8677, Japan
National Hospital Organization Himeji Medical Center
Himeji, 670-8520, Japan
National Hospital Organization Iwakuni Clinical Center
Iwakuni, 740-8510, Japan
Matsusaka Municipal Hospital
Matsusaka, 515-8544, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, 791-0280, Japan
National Hospital Organization Tokyo Medical Center
Meguro City, 152-8902, Japan
Iwate Medical University Hospital
Morioka, 028-3695, Japan
Shizuoka Cancer Center
Nagaizumi-chō, 411-8777, Japan
National Hospital Organization Nagoya Medical Center
Nagoya, 460-0001, Japan
Nagoya University Hospital
Nagoya, 466-8560, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Osaka, 541-8567, Japan
NHO Kinki Chuo Chest Medical Center
Sakai, 591-8555, Japan
Sendai Kousei Hospital
Sendai, 981-0914, Japan
Wakayama Medical University Hospital
Wakayama, 641-8510, Japan
Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii
Gdansk, 80-211, Poland
Instytut MSF Sp. z o.o.
Lodz, 90-302, Poland
NZOZ Medpolonia Sp. Z o.o.
Poznan, 60-693, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemyśl, 37-700, Poland
Coltea Clinical Hospital
Bucharest, 030171, Romania
SC Gral Medical SRL
Bucharest, 031424, Romania
Cardiomed
Cluj-Napoca, 400015, Romania
S.C. Medisprof S.R.L, Oncologie medicala
Cluj-Napoca, 400641, Romania
Radiotherapy Center Cluj
Cluj-Napoca, 407280, Romania
Onco Clinic Consult SA
Craiova, 200094, Romania
Centrul de Oncologie Sf. Nectarie S.R.L (Sf Nectarie Oncology Center)
Craiova, 200542, Romania
Ovidius Clinical Hospital
Ovidiu, 905900, Romania
Municipal Hospital Ploiesti
Ploieşti, 100337, Romania
Oncomed
Timișoara, 300239, Romania
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Chungnam National University Hospital (CNUH)
Daejeon, 35015, South Korea
National Cancer Center
Goyang-si, 10408, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Gyeongsang National University Hospital (GNUH)
Jinju, 52727, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center (AMC)
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
The Catholic University Of Korea, St. Vincent's Hospital
Suwon, 16247, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Hospital Universitario de Badajoz
Badajoz, 6006, Spain
Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
Badalona, 08916, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Consorcio Hospitalario Provincial de Castellón
Castellon, 12002, Spain
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria, 35016, Spain
Hospital Universitario De Leon
León, 24080, Spain
Hospital Universitari de Lleida Arnau de Villanova
Lleida, 25198, Spain
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, 28007, Spain
Clinica MD Anderson International
Madrid, 28033, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, 28222, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, 38320, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Universitario Nuestra Senora De Valme
Seville, 41014, Spain
Fundacion Instituto Valenciano de Oncologia
Valencia, 46009, Spain
Hospital General Universitario De Valencia
Valencia, 46014, Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, 46026, Spain
Hospital Alvaro Cunqueiro
Vigo, 36312, Spain
Hospital Universitario Miguel Servet de Zaragoza
Zaragoza, 50009, Spain
Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Bangkok, 10300, Thailand
Chulalongkorn University
Bangkok, 10330, Thailand
Chiangrai Prachanukroh Hospital
Chiang Rai, 57000, Thailand
Lampang Cancer Hospital
Lampang, 52000, Thailand
HRH Princess MahaChakri Sirindhorn Medical Center - Srinakharinwirot University
Nakhon Nayok, 26120, Thailand
Rajavithi Hospital
Ratchathewi, 10400, Thailand
Baskent Universitesi Tip Fakultesi Adana Hastanesi
Adana, 1120, Turkey (Türkiye)
Adana City Training and Research Hospital
Adana, 1370, Turkey (Türkiye)
Gulhane Training and Research Hospital
Ankara, 06010, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, 06200, Turkey (Türkiye)
Hacettepe University Medicine Faculty
Ankara, 06230, Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, 06520, Turkey (Türkiye)
Liv Hospital Ankara
Ankara, 06680, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, 06800, Turkey (Türkiye)
Akdeniz University Hospital
Antalya, 7985, Turkey (Türkiye)
Dicle University Faculty of Medicine Hospital
Diyarbakır, 21280, Turkey (Türkiye)
Gaziantep Sanko University Medical Faculty
Gaziantep, 36020, Turkey (Türkiye)
Bezmialem Foundation University Medical Faculty
Istanbul, 34093, Turkey (Türkiye)
Istinye University Bahcesehir Liv Hospital
Istanbul, 34517, Turkey (Türkiye)
Yeditepe University Kosuyolu Hospital
Istanbul, 34718, Turkey (Türkiye)
Medical Point Izmir Hospital
Izmir, 35325, Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Kadıköy, 34722, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380, Turkey (Türkiye)
Medical Park Florya Hospital
Küçükçekmece, 34295, Turkey (Türkiye)
Karadeniz Technical University Faculty of Medicine
Ortahisar, 61080, Turkey (Türkiye)
Sakarya University - Faculty of Medicine
Sakarya, 54290, Turkey (Türkiye)
Ondokuz Mayis University Health Practice and Research Hospital
Samsun, 55280, Turkey (Türkiye)
Acibadem Adana Hospital
Seyhan, 01130, Turkey (Türkiye)
Medical Park Seyhan Hospital
Seyhan, 01170, Turkey (Türkiye)
Mersin City Training and Research Hospital
Toroslar, 33240, Turkey (Türkiye)
Gazi University Faculty of Medicine
Yenimahalle, 06560, Turkey (Türkiye)
Koc Universitesi Hastanesi (Koc University Hospital)
Zeytinburnu, 34010, Turkey (Türkiye)
Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
Brighton, BN2 5BE, United Kingdom
Velindre NHS Trust, Velindre Cancer Centre
Cardiff, CF14 2TL, United Kingdom
Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
Chelsea, SW3 6JJ, United Kingdom
Hull University Teaching Hospitals NHS Trust
Cottingham, HU16 5JQ, United Kingdom
Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board
Glasgow, G12 0YN, United Kingdom
Clatterbridge Cancer Centre
Liverpool, L7 8YA, United Kingdom
University College Hospital
London, NW2 1PG, United Kingdom
Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust
London, SM2 5PT, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, NR4 7UY, United Kingdom
Cancer And Haematology Centre-The Churchill Hospital-Oxford University Hospitals
Oxford, OX3 7LJ, United Kingdom
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
Preston, PR2 9HT, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
BioNTech Responsible Person
BioNTech SE
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2024
First Posted
December 2, 2024
Study Start
January 7, 2025
Primary Completion (Estimated)
February 1, 2029
Study Completion (Estimated)
March 1, 2030
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share