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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Paclitaxel; Drug: Pemetrexed; Drug: Carboplatin; Drug: Pembrolizumab; Drug: Pumitamig

Detailed Description

Each substudy contains a Phase 2 part followed by a Phase 3 part. Participants will be randomized to one of two dose levels of pumitamig (BNT327) plus chemotherapy for the Phase 2 part of each substudy. For the Phase 3 part of both substudies, an independent data monitoring committee (IDMC) and a blinded Independent Central Review (BICR) will be established. The IDMC will provide independent review of the data during the study as needed and the BICR will review all available tumor assessment scans for all treated participants.

The planned study duration per study participant is up to 64 months.

• Study Type: Interventional
• Enrollment (Estimated): 1260
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: BioNTech clinical trials patient information; Phone Number: +49 6131 9084; Email: patients@biontech.de

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • Recruiting
    • Royal Adelaide Hospital
  • Adelaide, Australia, 5000
    • Recruiting
    • Cancer Research Sa (Crsa)
  • Bedford Park, Australia, 5042
    • Recruiting
    • Flinders Medical Centre
  • Cairns, Australia, 4870
    • Recruiting
    • Cairns Hospital
  • Dubbo, Australia, 2830
    • Recruiting
    • Dubbo Hospital
  • Frankston, Australia, 3199
    • Recruiting
    • Peninsula & South Eastern Haematology and Oncology Group
  • Kurralta Park, Australia, 5037
    • Recruiting
    • Icon Cancer Centre Kurralta Park
  • Melbourne, Australia, 3000
    • Recruiting
    • Peter MacCallum Cancer Centre
  • Melbourne, Australia, 3168
    • Recruiting
    • Monash University - Monash Health -Monash Medical Centre
  • Orange, Australia, 2800
    • Recruiting
    • Central West Cancer Care Centre
  • St Albans, Australia, 3021
    • Recruiting
    • Western Health Sunshine Hospital
  • Townsville, Australia, 4812
    • Recruiting
    • Icon Cancer Care - Townsville
  • Wollongong, Australia, 2500
    • Recruiting
    • Cancer Care Wollongong Pty Limited
• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • Universitair Ziekenhuis Leuven
  • Mons, Belgium, 7000
    • Recruiting
    • CHU HELORA, Hopital de Mons - Site Kennedy
  • Sint-Niklaas, Belgium, 9100
    • Recruiting
    • Vitaz
• China
  • Baoding, China, 071000
    • Recruiting
    • Affiliated Hospital of Hebei University
  • Beijing, China, 100730
    • Recruiting
    • Peking Union Medical College Hospital
  • Beijing, China, 100050
    • Recruiting
    • Beijing Friendship Hospital, Capital Medical University
  • Beijing, China, 100730
    • Recruiting
    • Beijing Hospital
  • Changchun, China, 130000
    • Recruiting
    • Jilin Cancer Hospital
  • Hangzhou, China, 310022
    • Recruiting
    • Zhejiang Medical University, Zhejiang Cancer Hospital
  • Jinan, China, 250013
    • Recruiting
    • Shandong University - Jinan Central Hospital
  • Kunming, China, 650118
    • Recruiting
    • Yunnan Provincial Cancer Hospital
  • Nanjing, China, 210029
    • Recruiting
    • Jiangsu Peoples Hospital
  • Shanghai, China, 200030
    • Recruiting
    • Shanghai Chest Hospital
  • Shantou, China, 515041
    • Recruiting
    • Cancer Hospital of Shantou University Medical College
  • Suzhou, China, 215006
    • Recruiting
    • The First Affiliated Hospital of Soochow University
  • Wanzhou, China, 404000
    • Recruiting
    • Chongqing University Three Gorges Hospital
  • Wuhan, China, 430071
    • Recruiting
    • Zhongnan Hospital of Wuhan University
  • Yangzhou, China, 225001
    • Recruiting
    • Northern Jiangsu Peoples Hospital (NJPH)
  • Zhejiang, China, 317000
    • Recruiting
    • Taizhou Hospital of Zhejiang Province
• France
  • Angers, France, 49933
    • Recruiting
    • Centre Hospitalier Universitaire d'Angers (CHU Angers)
  • Angers, France, 49055
    • Recruiting
    • Institut de Cancerologie de l'Ouest Paul Papin
  • Bordeaux, France, 33076
    • Recruiting
    • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
  • Caen, France, 14076
    • Recruiting
    • Centre Francois Baclesse
  • Caen, France, 14033
    • Recruiting
    • CHU Caen Normandie
  • Créteil, France, 94010
    • Recruiting
    • Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.)
  • Marseille, France, 13009
    • Recruiting
    • Institut Paoli-Calmettes
  • Mulhouse, France, 68100
    • Recruiting
    • Ghrmsa Hopital Emile Muller
  • Paris, France, 75005
    • Recruiting
    • Institut Curie - Centre de Recherche
  • Rennes, France, 35033
    • Recruiting
    • CHU de Rennes, Hopital de Pontchaillou
  • Saint-Herblain, France, 44805
    • Recruiting
    • Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau
  • Toulon, France, 83000
    • Recruiting
    • Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre
  • Villejuif, France, 94805
    • Recruiting
    • Institut Gustave Roussy-Gustave Roussy Cancer Center -Ditep
• Georgia
  • Batumi, Georgia, 6000
    • Recruiting
    • High Technology Hospital MedCenter Ltd
  • Tbilisi, Georgia, 0144
    • Recruiting
    • Ltd Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
  • Tbilisi, Georgia, 0112
    • Recruiting
    • Llc Todua Clinic
  • Tbilisi, Georgia, 0162
    • Recruiting
    • New Hospitals
  • Tbilisi, Georgia, 0179
    • Recruiting
    • Cancer Research Centre
• Germany
  • Aachen, Germany, 52074
    • Recruiting
    • Uniklinik RWTH Aachen Medizinische Klinik IV
  • Berlin, Germany, 13125
    • Recruiting
    • Evangelische Lungenklinik Berlin
  • Chemnitz, Germany, 09116
    • Recruiting
    • Klinikum Chemnitz gGmbH
  • Erlangen, Germany, 91054
    • Recruiting
    • Universitätsklinikum Erlangen
  • Esslingen am Neckar, Germany, 73730
    • Recruiting
    • Klinikum Esslingen GmbH
  • Gauting, Germany, 82131
    • Recruiting
    • Asklepios Fachkliniken Muenchen Gauting
  • Gera, Germany, 07548
    • Recruiting
    • SRH Wald-Kliniken Gera GmbH
  • Heidelberg, Germany, 69126
    • Recruiting
    • Thoraxklinik-Heidelberg gGmbH
  • Immenhausen, Germany, 34376
    • Recruiting
    • Lungenfachklinik Immenhausen - Pneumologische Lehrklinik der Universitaet Goettingen
  • Mainz, Germany, 55131
    • Recruiting
    • University Medical Center of Johannes Gutenberg-University Mainz
  • München, Germany, 81925
    • Recruiting
    • Staedtisches Klinikum Muenchen Bogenhausen
  • Neuss, Germany, 41462
    • Recruiting
    • MVZ for oncology and hematology Rhein-Kreis Neuss GmbH
  • Remscheid, Germany, 42853
    • Recruiting
    • Onkologische Tagesklinik Remscheid
  • Wesseling, Germany, 50389
    • Recruiting
    • Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling
  • Wuppertal, Germany, 42883
    • Recruiting
    • Helios Klinikum Wuppertal-Universitaet Witten-Herdecke
• Italy
  • Avellino, Italy, 83100
    • Recruiting
    • Azienda Ospedaliera San Giuseppe Moscati
  • Aviano, Italy, 33081
    • Recruiting
    • Centro di riferimento Oncologico
  • Bologna, Italy, 40138
    • Recruiting
    • Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi
  • Cremona, Italy, 26100
    • Recruiting
    • Azienda Socio Sanitaria Territoriale di Cremona (ASST Cremona)
  • Lucca, Italy, 55100
    • Recruiting
    • Ospedale San Luca
  • Meldola, Italy, 47014
    • Recruiting
    • IRCCS Istituto Romagnolo per lo studio dei Tumori Dino Amadori (IRST)
  • Milan, Italy, 20132
    • Recruiting
    • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
  • Naples, Italy, 80131
    • Recruiting
    • UOC Oncoematologia AOU Luigi Vanvitelli
  • Peschiera del Garda, Italy, 37019
    • Recruiting
    • Casa Di Cura Polispecialistica Dott Pederzoli
  • Roma, Italy, 00128
    • Recruiting
    • Fondazione Policlinico Universitario Campus Bio-medico
  • Roma, Italy, 00144
    • Recruiting
    • Istituti di Ricovero e Cura A Carattere Scientifico (IRCCS) - Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE)
  • Rome, Italy, 00186
    • Recruiting
    • Fondazione Ospedale Isola Tiberina - Gemelli Isola
  • Siena, Italy, 53100
    • Recruiting
    • Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte
• Japan
  • Ageo, Japan, 362-8588
    • Recruiting
    • Ageo Central General Hospital
  • Bunkyō City, Japan, 113-8677
    • Recruiting
    • Tokyo Metropolitan Komagome Hospital
  • Himeji, Japan, 670-8520
    • Recruiting
    • National Hospital Organization Himeji Medical Center
  • Iwakuni, Japan, 740-8510
    • Recruiting
    • National Hospital Organization Iwakuni Clinical Center
  • Matsusaka, Japan, 515-8544
    • Recruiting
    • Matsusaka Municipal Hospital
  • Matsuyama, Japan, 791-0280
    • Recruiting
    • National Hospital Organization Shikoku Cancer Center
  • Meguro City, Japan, 152-8902
    • Recruiting
    • National Hospital Organization Tokyo Medical Center
  • Morioka, Japan, 028-3695
    • Recruiting
    • Iwate Medical University Hospital
  • Nagaizumi-chō, Japan, 411-8777
    • Recruiting
    • Shizuoka Cancer Center
  • Nagoya, Japan, 466-8560
    • Recruiting
    • Nagoya University Hospital
  • Nagoya, Japan, 460-0001
    • Recruiting
    • National Hospital Organization Nagoya Medical Center
  • Niigata, Japan, 951-8566
    • Recruiting
    • Niigata Cancer Center Hospital
  • Osaka, Japan, 541-8567
    • Recruiting
    • Osaka Prefectural Hospital Organization Osaka International Cancer Institute
  • Sakai, Japan, 591-8555
    • Recruiting
    • NHO Kinki Chuo Chest Medical Center
  • Sendai, Japan, 981-0914
    • Recruiting
    • Sendai Kousei Hospital
  • Wakayama, Japan, 641-8510
    • Recruiting
    • Wakayama Medical University Hospital
• Poland
  • Gdansk, Poland, 80-211
    • Recruiting
    • Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii
  • Lodz, Poland, 90-302
    • Recruiting
    • Instytut MSF Sp. z o.o.
  • Poznan, Poland, 60-693
    • Recruiting
    • NZOZ Medpolonia Sp. Z o.o.
  • Przemyśl, Poland, 37-700
    • Recruiting
    • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
• Romania
  • Bucharest, Romania, 030171
    • Recruiting
    • Coltea Clinical Hospital
  • Bucharest, Romania, 031424
    • Recruiting
    • SC Gral Medical SRL
  • Cluj-Napoca, Romania, 400015
    • Recruiting
    • Cardiomed
  • Cluj-Napoca, Romania, 400641
    • Recruiting
    • S.C. Medisprof S.R.L, Oncologie medicala
  • Cluj-Napoca, Romania, 407280
    • Recruiting
    • Radiotherapy Center Cluj
  • Craiova, Romania, 200094
    • Recruiting
    • Onco Clinic Consult SA
  • Craiova, Romania, 200542
    • Recruiting
    • Centrul de Oncologie Sf. Nectarie S.R.L (Sf Nectarie Oncology Center)
  • Ovidiu, Romania, 905900
    • Recruiting
    • Ovidius Clinical Hospital
  • Ploieşti, Romania, 100337
    • Recruiting
    • Municipal Hospital Ploiesti
  • Timișoara, Romania, 300239
    • Recruiting
    • OncoMed
• South Korea
  • Cheongju-si, South Korea, 28644
    • Recruiting
    • Chungbuk National University Hospital
  • Daejeon, South Korea, 35015
    • Recruiting
    • Chungnam National University Hospital (CNUH)
  • Goyang-si, South Korea, 10408
    • Recruiting
    • National Cancer Center
  • Incheon, South Korea, 21565
    • Recruiting
    • Gachon University Gil Medical Center
  • Jinju, South Korea, 52727
    • Recruiting
    • Gyeongsang National University Hospital (GNUH)
  • Seoul, South Korea, 03722
    • Recruiting
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 06351
    • Recruiting
    • Samsung Medical Center
  • Seoul, South Korea, 08308
    • Recruiting
    • Korea University Guro Hospital
  • Seoul, South Korea, 05505
    • Recruiting
    • Asan Medical Center (AMC)
  • Suwon, South Korea, 16499
    • Recruiting
    • Ajou University Hospital
  • Suwon, South Korea, 16247
    • Recruiting
    • The Catholic university of Korea, St. Vincent's Hospital
• Spain
  • Badajoz, Spain, 6006
    • Recruiting
    • Hospital Universitario de Badajoz
  • Badalona, Spain, 08916
    • Recruiting
    • Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitario Vall d'Hebron
  • Castellon, Spain, 12002
    • Recruiting
    • Consorcio Hospitalario Provincial de Castellon
  • Las Palmas de Gran Canaria, Spain, 35016
    • Recruiting
    • Complejo Hospitalario Universitario Insular Materno Infantil
  • León, Spain, 24080
    • Recruiting
    • Hospital Universitario de Leon
  • Lleida, Spain, 25198
    • Recruiting
    • Hospital Universitari de Lleida Arnau de Villanova
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Universitario Fundación Jiménez Díaz
  • Madrid, Spain, 28007
    • Recruiting
    • Hospital General Universitario Gregorio Maranon (HGUGM)
  • Madrid, Spain, 28033
    • Recruiting
    • Clinica MD Anderson International
  • Majadahonda, Spain, 28222
    • Recruiting
    • Hospital Universitario Puerta de Hierro de Majadahonda
  • Santa Cruz de Tenerife, Spain, 38320
    • Recruiting
    • Hospital Universitario de Canarias
  • Seville, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocio
  • Seville, Spain, 41014
    • Recruiting
    • Hospital Universitario Nuestra Señora de Valme
  • Valencia, Spain, 46014
    • Recruiting
    • Hospital General Universitario de Valencia
  • Valencia, Spain, 46009
    • Recruiting
    • Fundación Instituto Valenciano de Oncología
  • Valencia, Spain, 46026
    • Recruiting
    • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
  • Vigo, Spain, 36312
    • Recruiting
    • Hospital Alvaro Cunqueiro
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Universitario Miguel Servet de Zaragoza
• Switzerland
  • Baden, Switzerland, 5404
    • Recruiting
    • Kantonspital Baden
  • Lausanne, Switzerland, 1011
    • Recruiting
    • Centre Hospitalier Universitaire Vaudois Lausanne (CHUV) - Centre de transplantation d'organes (CTO)
• Thailand
  • Bangkok, Thailand, 10330
    • Recruiting
    • Chulalongkorn University
  • Bangkok, Thailand, 10300
    • Recruiting
    • Faculty of Medicine Vajira Hospital, Navamindradhiraj University
  • Chiang Rai, Thailand, 57000
    • Recruiting
    • Chiangrai Prachanukroh Hospital
  • Lampang, Thailand, 52000
    • Recruiting
    • Lampang Cancer Hospital
  • Nakhon Nayok, Thailand, 26120
    • Recruiting
    • HRH Princess MahaChakri Sirindhorn Medical Center - Srinakharinwirot University
  • Ratchathewi, Thailand, 10400
    • Recruiting
    • Rajavithi Hospital
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 1370
    • Recruiting
    • Adana City Training and Research Hospital
  • Adana, Turkey (Türkiye), 1120
    • Recruiting
    • Baskent Universitesi Tip Fakultesi Adana Hastanesi
  • Ankara, Turkey (Türkiye), 06010
    • Recruiting
    • Gulhane Training and Research Hospital
  • Ankara, Turkey (Türkiye), 06680
    • Recruiting
    • Liv Hospital Ankara
  • Ankara, Turkey (Türkiye), 06200
    • Recruiting
    • Dr. Abdurrahman Yurtaslan Ankara Oncology Training And Research Hospital
  • Ankara, Turkey (Türkiye), 06520
    • Recruiting
    • Memorial Ankara Hospital
  • Ankara, Turkey (Türkiye), 06800
    • Recruiting
    • Ankara Bilkent City Hospital
  • Ankara, Turkey (Türkiye), 06230
    • Recruiting
    • Hacettepe University Medicine Faculty
  • Antalya, Turkey (Türkiye), 7985
    • Recruiting
    • Akdeniz University Hospital
  • Diyarbakır, Turkey (Türkiye), 21280
    • Recruiting
    • Dicle University Faculty of Medicine Hospital
  • Gaziantep, Turkey (Türkiye), 36020
    • Recruiting
    • Gaziantep Sanko University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34093
    • Recruiting
    • Bezmialem Foundation University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34517
    • Recruiting
    • Istinye University Bahcesehir Liv Hospital
  • Istanbul, Turkey (Türkiye), 34718
    • Recruiting
    • Yeditepe University Kosuyolu Hospital
  • Izmir, Turkey (Türkiye), 35325
    • Recruiting
    • Medical Point Izmir Hospital
  • Kadıköy, Turkey (Türkiye), 34722
    • Recruiting
    • Goztepe Prof. Dr. Suleyman Yalcin City Hospital
  • Kocaeli, Turkey (Türkiye), 41380
    • Recruiting
    • Kocaeli Universitesi Tip Fakultesi
  • Konya, Turkey (Türkiye), 42080
    • Recruiting
    • Necmettin Erbakan University Meram Medical Faculty
  • Küçükçekmece, Turkey (Türkiye), 34295
    • Recruiting
    • Medical Park Florya Hospital
  • Ortahisar, Turkey (Türkiye), 61080
    • Recruiting
    • Karadeniz Technical University Faculty of Medicine
  • Sakarya, Turkey (Türkiye), 54290
    • Recruiting
    • Sakarya University - Faculty of Medicine
  • Samsun, Turkey (Türkiye), 55280
    • Recruiting
    • Ondokuz Mayis University Health Practice and Research Hospital
  • Seyhan, Turkey (Türkiye), 01130
    • Recruiting
    • Acibadem Adana Hospital
  • Seyhan, Turkey (Türkiye), 01170
    • Recruiting
    • Medical Park Seyhan Hospital
  • Toroslar, Turkey (Türkiye), 33240
    • Recruiting
    • Mersin City Training and Research Hospital
  • Yenimahalle, Turkey (Türkiye), 06560
    • Recruiting
    • Gazi University Faculty of Medicine
  • Zeytinburnu, Turkey (Türkiye), 34010
    • Recruiting
    • Koc Universitesi Hastanesi (Koc University Hospital)
• United Kingdom
  • Brighton, United Kingdom, BN2 5BE
    • Recruiting
    • Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
  • Cardiff, United Kingdom, CF14 2TL
    • Recruiting
    • Velindre NHS Trust, Velindre Cancer Centre
  • Chelsea, United Kingdom, SW3 6JJ
    • Recruiting
    • Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
  • Cottingham, United Kingdom, HU16 5JQ
    • Recruiting
    • Hull University Teaching Hospitals NHS Trust
  • Glasgow, United Kingdom, G12 0YN
    • Recruiting
    • Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board
  • Liverpool, United Kingdom, L7 8YA
    • Recruiting
    • Clatterbridge Cancer Centre
  • London, United Kingdom, NW2 1PG
    • Recruiting
    • University College Hospital
  • London, United Kingdom, SM2 5PT
    • Recruiting
    • Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust
  • Manchester, United Kingdom, M20 4BX
    • Recruiting
    • The Christie NHS Foundation Trust
  • Norwich, United Kingdom, NR4 7UY
    • Recruiting
    • Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust
  • Oxford, United Kingdom, OX3 7LJ
    • Recruiting
    • Cancer And Haematology Centre-The Churchill Hospital-Oxford University Hospitals
  • Preston, United Kingdom, PR2 9HT
    • Recruiting
    • Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
  • Sheffield, United Kingdom, S10 2SJ
    • Recruiting
    • Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust
  • Southampton, United Kingdom, SO16 6YD
    • Recruiting
    • Southampton General Hospital
  • Wolverhampton, United Kingdom, WV10 0QP
    • Recruiting
    • New Cross Hospital
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Recruiting
      • Alaska Oncology and Hematology, LLC
  • California
    • Concord, California, United States, 94520
      • Recruiting
      • John Muir Clinical Research Center
    • La Jolla, California, United States, 92093
      • Recruiting
      • University Of California - San Diego Moores Cancer Center
  • Florida
    • Clermont, Florida, United States, 34711
      • Recruiting
      • Clermont Oncology Center
    • Orange City, Florida, United States, 32763
      • Recruiting
      • Mid Florida Cancer Centers
    • Stuart, Florida, United States, 34994
      • Recruiting
      • Cleveland Clinic Florida - Martin North Hospital
    • Tampa, Florida, United States, 33612
      • Recruiting
      • H. Lee Moffit Cancer center and research institute
    • Weston, Florida, United States, 33331
      • Recruiting
      • Cleveland Clinic Weston Hospital
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Recruiting
      • Fort Wayne Medical Oncology and Hematology, Inc.
  • Iowa
    • Cedar Rapids, Iowa, United States, 52401-2112
      • Recruiting
      • Physicians Clinic of Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics
  • Kentucky
    • Elizabethtown, Kentucky, United States, 42701
      • Recruiting
      • Baptist Health Hardin
  • Maryland
    • Frederick, Maryland, United States, 21704
      • Recruiting
      • Frederick Health Hospital- James M Stockman Cancer Institute
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Recruiting
      • Missouri Cancer Associates
    • Fenton, Missouri, United States, 63026
      • Recruiting
      • SSM Health Cancer Care - St. Clare
  • Nebraska
    • Hastings, Nebraska, United States, 68901-4470
      • Recruiting
      • Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC)
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Recruiting
      • Astera Cancer Care
    • Florham Park, New Jersey, United States, 07932
      • Recruiting
      • Summit Medical Group PA
    • Paramus, New Jersey, United States, 07652
      • Recruiting
      • The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion
  • New York
    • Stony Brook, New York, United States, 11794-9446
      • Recruiting
      • Suny-Stony Brook University Cancer Center
    • White Plains, New York, United States, 10601
      • Recruiting
      • White Plains Hospital
  • North Carolina
    • Hendersonville, North Carolina, United States, 28792
      • Recruiting
      • Fletcher Hospital, Inc. dba AdventHealth Hendersonville
  • Ohio
    • Canton, Ohio, United States, 44718
      • Recruiting
      • Gabrail Cancer Center Research
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • University of Cincinnati Medical Center
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • The Christ Hospital Cancer Center
    • Cleveland, Ohio, United States, 44195-0001
      • Recruiting
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44111
      • Recruiting
      • The Cleveland Clinic Cancer Center at Fairview Hospital, Moll Pavilion
    • Kettering, Ohio, United States, 45429
      • Recruiting
      • Kettering Medical Center
    • Mayfield Heights, Ohio, United States, 44124
      • Recruiting
      • Cleveland Clinic - Hillcrest Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73109
      • Recruiting
      • Integris Cancer Institute of Oklahoma
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Recruiting
      • University of Tennessee Medical Center
    • Memphis, Tennessee, United States, 38120
      • Recruiting
      • Baptist Cancer Center
  • Texas
    • Houston, Texas, United States, 77090
      • Active, not recruiting
      • Millennium Research and Clinical Development, LLC
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Virginia Cancer Specialists
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Vcu Massey Cancer Center
    • Winchester, Virginia, United States, 22601
      • Recruiting
      • Shenandoah Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Substudy A Phase 3 - Pembrolizumab + Carboplatin + Pemetrexed	Drug: Pemetrexed; Intravenous infusion; Drug: Carboplatin; Intravenous infusion; Drug: Pembrolizumab; Intravenous infusion
Active Comparator: Substudy B Phase 3 - Pembrolizumab + Carboplatin + Paclitaxel	Drug: Paclitaxel; Intravenous infusion; Drug: Carboplatin; Intravenous infusion; Drug: Pembrolizumab; Intravenous infusion
Experimental: Substudy A Phase 2 - Pumitamig Dose 1 + Carboplatin + Pemetrexed	Drug: Pemetrexed; Intravenous infusion; Drug: Carboplatin; Intravenous infusion; Drug: Pumitamig; Intravenous infusion; Other Names: BNT327
Experimental: Substudy A Phase 2 - Pumitamig Dose 2 + Carboplatin + Pemetrexed	Drug: Pemetrexed; Intravenous infusion; Drug: Carboplatin; Intravenous infusion; Drug: Pumitamig; Intravenous infusion; Other Names: BNT327
Experimental: Substudy B Phase 2 - Pumitamig Dose 1 + Carboplatin + Paclitaxel	Drug: Paclitaxel; Intravenous infusion; Drug: Carboplatin; Intravenous infusion; Drug: Pumitamig; Intravenous infusion; Other Names: BNT327
Experimental: Substudy B Phase 2 - Pumitamig Dose 2 + Carboplatin + Paclitaxel	Drug: Paclitaxel; Intravenous infusion; Drug: Carboplatin; Intravenous infusion; Drug: Pumitamig; Intravenous infusion; Other Names: BNT327
Experimental: Substudy A Phase 3 - Pumitamig + Carboplatin + Pemetrexed; Pumitamig dose 3 for Phase 3	Drug: Pemetrexed; Intravenous infusion; Drug: Carboplatin; Intravenous infusion; Drug: Pumitamig; Intravenous infusion; Other Names: BNT327
Experimental: Substudy B Phase 3 - Pumitamig + Carboplatin + Paclitaxel; Pumitamig dose 3 for Phase 3	Drug: Paclitaxel; Intravenous infusion; Drug: Carboplatin; Intravenous infusion; Drug: Pumitamig; Intravenous infusion; Other Names: BNT327

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 - 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 - 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 3 - Overall survival (OS)	For substudies A and B. OS defined as the time from randomization to death from any cause	Up to approximately 5 years
Phase 2 - Duration of Response (DOR)	For substudies A and B. DOR defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v1.1) or death from any cause, whichever occurs first.	Up to approximately 2 years
Phase 3 - PFS assessed by investigator	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
Phase 3 - PFS rate as assessed by BICR	For substudies A and B.	At 6, 12, and 18 months
Phase 3 - PFS rate as assessed by investigator	For substudies A and B.	At 6, 12, and 18 months
Phase 3 - OS rate	For substudies A and B.	At 6, 12, 18, 24 months
Phase 3 - Occurrence of TEAEs including Grade ≥3, serious, and fatal TEAEs by relationship	For substudies A and B. AEs graded according to CTCAE v5.0.	From the first dose of IMP to the 90-day Follow-Up Visit
Phase 3 - 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 - Disease Control Rate (DCR)	For substudies A and B. DCR defined as the proportion of participants in whom a confirmed CR or confirmed PR or stable disease (per RECIST v1.1, stable disease assessed at least 6 weeks after randomization) is observed as best overall response.	Up to approximately 2 years
Phase 3 - ORR	For substudies A and B. ORR defined as the proportion of participants in whom a confirmed CR or confirmed PR (per RECIST v1.1) is observed as best overall response.	Up to approximately 2 years
Phase 3 - Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-life-score 30 Questionnaire (QLQ-C30) global health status/Quality-of-Life (QoL) score (Items 29 and 30)	For substudies A and B. The EORTC QLQ-C30 is the most widely used cancer-specific, health related QoL instrument containing a total of 30 items and measures 5 functional scales (physical, role, emotional, cognitive, and social), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status/QoL scale. All the scales and single-item measures range in score from 0 to 100 with a high scale score representing a higher response level (i.e., high score for global health status/QoL is high QoL: high score for symptom scale/item is high symptomatology or problems).	Up to approximately 5 years
Phase 3 - Change from baseline in EORTC QLQ-C30 physical functioning	For substudies A and B. The EORTC QLQ-C30 is the most widely used cancer-specific, health related QoL instrument containing a total of 30 items and measures 5 functional scales (physical, role, emotional, cognitive, and social), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status/QoL scale. All the scales and single-item measures range in score from 0 to 100 with a high scale score representing a higher response level (i.e., high score for functional scale is high/healthy level of functioning).	Up to approximately 5 years
Phase 3 - Change from baseline in coughing scale of the EORTC lung cancer-specific quality-of-life questionnaire (QLQ-LC29)	For substudies A and B. The EORTC QLQ-LC29 is a disease-specific supplementary health-related quality-of-life (HRQoL) questionnaire module to be employed in conjunction with the QLQ-C30. It comprises 29 items and measures five multi-item scales (coughing, shortness of breath, side effects, tumor progression/existential issues, surgery-related symptoms) and five single items (coughing up blood, pain in chest, arm/shoulder and other parts of the body, and weight loss). All the scales and single-item measures range in score from 0 to 100 with a high score for the scales and single items representing a high level of symptomatology or problems.	Up to approximately 5 years
Phase 3 - Change from baseline in shortness of breath scale of the EORTC QLQ-LC29	For substudies A and B. The EORTC QLQ-LC29 is a disease-specific supplementary health-related quality-of-life (HRQoL) questionnaire module to be employed in conjunction with the QLQ-C30. It comprises 29 items and measures five multi-item scales (coughing, shortness of breath, side effects, tumor progression/existential issues, surgery-related symptoms) and five single items (coughing up blood, pain in chest, arm/shoulder and other parts of the body, and weight loss). All the scales and single-item measures range in score from 0 to 100 with a high score for the scales and single items representing a high level of symptomatology or problems.	Up to approximately 5 years
Phase 3 - Change from baseline in coughed up blood item of the EORTC QLQ-LC29	For substudies A and B. The EORTC QLQ-LC29 is a disease-specific supplementary health-related quality-of-life (HRQoL) questionnaire module to be employed in conjunction with the QLQ-C30. It comprises 29 items and measures five multi-item scales (coughing, shortness of breath, side effects, tumor progression/existential issues, surgery-related symptoms) and five single items (coughing up blood, pain in chest, arm/shoulder and other parts of the body, and weight loss). All the scales and single-item measures range in score from 0 to 100 with a high score for the scales and single items representing a high level of symptomatology or problems.	Up to approximately 5 years
Phase 3 - Change from baseline in fatigue domain score scale of the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)	For substudies A and B. The NSCLC-SAQ is a 7-item patient-reported outcome measure for use in adults to assess symptoms of advanced non-small cell lung cancer. It contains five domains and accompanying items that were identified as symptoms of non small cell lung cancer: cough (1 item), pain (2), dyspnea (1), fatigue (2), and appetite (1). The (total) lowest score possible is 0, and the highest (total) score possible is 20. Higher scores indicate more severe symptoms.	Up to approximately 5 years
Phase 3 - Change from baseline in pain domain score of the NSCLC-SAQ	For substudies A and B. The NSCLC-SAQ is a 7-item PRO measure for use in adults to assess symptoms of advanced non-small cell lung cancer. It contains five domains and accompanying items that were identified as symptoms of non small cell lung cancer: cough (1 item), pain (2), dyspnea (1), fatigue (2), and appetite (1). The (total) lowest score possible is 0, and the highest (total) score possible is 20. Higher scores indicate more severe symptoms.	Up to approximately 5 years
Phase 3 - Change from baseline in Functional Assessment of Cancer Therapy-General item 5 overall bother item (FACT-GP5).	For substudies A and B. The FACT-G - Item GP5 (Version 4) is a single-item summary measure of the overall impact of treatment toxicity, based upon its association with the number and degree of AEs in clinical studies. The single-item GP5 ("I am bothered by side effects of treatment") is rated on a 5-point Likert scale ("not at all" to "very much") with a recall period of past 7 days.	Up to approximately 5 years

Collaborators and Investigators

• Sponsor: BioNTech SE
• Collaborators: Bristol-Myers Squibb
• Investigators: Study Director: BioNTech Responsible Person, BioNTech SE

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Immunotherapy; Bispecific antibody; First-line treatment; Programmed death-ligand 1 (PD-L1); Programmed Death-1 monoclonal antibodies; Combination with chemotherapy; Combination with other investigational agents; Vascular endothelial growth factor (VEGF) A
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Pemetrexed; Carboplatin; Paclitaxel; pembrolizumab
• Other Study ID Numbers: BNT327-06; 2024-515764-31-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No