AzTrials
AzTrials

Non-small Cell Lung CancerPhase 2/3NCT06712316

Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)

A Phase 2/3 study testing Pumitamig, Pembrolizumab and Carboplatin in people with Non-small Cell Lung Cancer, run by BioNTech SE at 366 sites in 22 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Pumitamig, Pembrolizumab and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,580 participants
Where
366 sitesin 22 countries
Study dates
7 Jan 2025to Dec 2031
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 as defined in the protocol.

Who cannot join

  • Have histologically or cytologically confirmed NSCLC with small-cell lung cancer or neuroendocrine histologic 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 neoadjuvant/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.
Show all 10Show fewer
  • 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).
  • Participants have superior vena cava syndrome or symptoms of spinal cord compression.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

366 sites in 22 countries. Contact the study team or a site near you to ask about taking part.

BioNTech clinical trials patient information contact

+49 6131 9084 ext. 0

patients@biontech.de

366 sites in 22 countries

United States54 sites, 51 recruiting

  • Alaska Oncology and Hematology, LLC

    Anchorage, Alaska, 99508

    Recruiting

  • Birmingham Hematology and Oncology Associates LLC d/b/a Alabama Oncology

    Birmingham, Alabama, 35223

    Recruiting

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

    Recruiting

  • Physicians Clinic of Iowa

    Cedar Rapids, Iowa, 52401-2112

    Recruiting

  • The Christ Hospital Cancer Center

    Cincinnati, Ohio, 45219

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

    Recruiting

  • Clermont Oncology Center

    Clermont, Florida, 34711

    Recruiting

  • The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion

    Cleveland, Ohio, 44111

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195-0001

    Recruiting

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

    Recruiting

  • John Muir Clinical Research Center

    Concord, California, 94520

    Recruiting

  • SSAK Partners, LLC.

    Coral Springs, Florida, 33065

    Recruiting

  • Dayton Physicians Network

    Dayton, Ohio, 45415

    Recruiting

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

    Recruiting

  • Baptist Health Hardin

    Elizabethtown, Kentucky, 42701

    Recruiting

  • Inova Schar Cancer

    Fairfax, Virginia, 22031

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Recruiting

  • SSM Health Cancer Care - St. Clare

    Fenton, Missouri, 63026

    Withdrawn

  • Summit Medical Group PA

    Florham Park, New Jersey, 07932

    Recruiting

  • Fort Wayne Medical Oncology and Hematology, Inc.

    Fort Wayne, Indiana, 46845

    Recruiting

  • Frederick Health Hospital- James M Stockman Cancer Institute

    Frederick, Maryland, 21704

    Recruiting

  • Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC)

    Hastings, Nebraska, 68901-4470

    Recruiting

  • Fletcher Hospital, Inc. dba AdventHealth Hendersonville

    Hendersonville, North Carolina, 28792

    Recruiting

  • Millennium Research and Clinical Development, LLC

    Houston, Texas, 77090

    Active, not recruiting

  • Indiana University Health University Hospital

    Indianapolis, Indiana, 46202

    Recruiting

  • Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

    Recruiting

  • Baptist Medical Center Jacksonville

    Jacksonville, Florida, 32207

    Recruiting

  • Kettering Medical Center

    Kettering, Ohio, 45429

    Recruiting

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

    Recruiting

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601-5467

    Recruiting

  • University Of California - San Diego Moores Cancer Center

    La Jolla, California, 92093

    Recruiting

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

    Recruiting

  • University of Kentucky Chandler Medical Center (UKCMC) - Markey Cancer Center (Lucille P. Markey Cancer Center)

    Lexington, Kentucky, 40536

    Recruiting

  • Northwest Georgia Oncology Centers, P.C.

    Marietta, Georgia, 30060

    Recruiting

  • Cleveland Clinic - Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

    Recruiting

  • Baptist Cancer Center

    Memphis, Tennessee, 38120

    Withdrawn

  • West Virginia University Hospitals - Mary Babb Randolph Cancer Center

    Morgantown, West Virginia, 26506-8110

    Recruiting

  • Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Recruiting

  • INTEGRIS Cancer Institute of Oklahoma

    Oklahoma City, Oklahoma, 73109

    Recruiting

  • Mid Florida Cancer Centers

    Orange City, Florida, 32763

    Recruiting

  • The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion

    Paramus, New Jersey, 07652

    Recruiting

  • Nuvance Health

    Poughkeepsie, New York, 12601

    Recruiting

  • Virginia Cancer Institute

    Richmond, Virginia, 23229

    Recruiting

  • VCU Massey Cancer Center

    Richmond, Virginia, 23298

    Recruiting

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

    Recruiting

  • Suny-Stony Brook University Cancer Center

    Stony Brook, New York, 11794-9446

    Recruiting

  • Cleveland Clinic Florida - Martin North Hospital

    Stuart, Florida, 34994

    Recruiting

  • H. Lee Moffit Cancer center and research institute

    Tampa, Florida, 33612

    Recruiting

  • Vail Health

    Vail, Colorado, 81657

    Recruiting

  • MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)

    Washington D.C., District of Columbia, 20007

    Recruiting

  • MEDSTAR Washington Hospital Center (MedStar Health Research Institute)

    Washington D.C., District of Columbia, 20010

    Recruiting

  • Cleveland Clinic Weston Hospital

    Weston, Florida, 33331

    Recruiting

  • White Plains Hospital

    White Plains, New York, 10601

    Recruiting

  • Shenandoah Oncology

    Winchester, Virginia, 22601

    Recruiting

Other trials in United States

Japan38 sites, 38 recruiting

  • Ageo Central General Hospital

    Ageo, 362-8588

    Recruiting

  • Hyogo Cancer Center

    Akashi, 673-8558

    Recruiting

  • Aomori Prefectural Central Hospital

    Aomori, 030-8553

    Recruiting

  • Tokyo Metropolitan Komagome Hospital

    Bunkyō City, 113-8677

    Recruiting

  • Hamamatsu University Hospital

    Chūōku, 431-3192

    Recruiting

  • Funabashi Municipal Medical Center

    Funabashi, 273-8588

    Recruiting

  • National Hospital Organization Himeji Medical Center

    Himeji, 670-8520

    Recruiting

  • Hiroshima Prefectural Hospital

    Hiroshima, 734-8530

    Recruiting

  • Hiroshima University Hospital

    Hiroshima, 734-8551

    Recruiting

  • Aso Iizuka Hospital

    Iizuka, 820-8505

    Recruiting

  • National Hospital Organization Iwakuni Clinical Center

    Iwakuni, 740-8510

    Recruiting

  • Shonan Kamakura General Hospital

    Kanagawa, 247-8533

    Recruiting

  • Ishikawa Prefectural Central Hospital

    Kanazawa, 920-8530

    Recruiting

  • Social Welfare Organization Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital

    Kumamoto, 861-4193

    Recruiting

  • Kurashiki Central Hospital

    Kurashiki, 710-8602

    Recruiting

  • Kurume University Hospital

    Kurume, 830-0011

    Recruiting

  • Matsusaka Municipal Hospital

    Matsusaka, 515-8544

    Recruiting

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, 791-0280

    Recruiting

  • National Hospital Organization Tokyo Medical Center

    Meguro City, 152-8902

    Recruiting

  • Dokkyo Medical University Hospital

    Mibu, 321-0293

    Recruiting

  • Iwate Medical University Hospital

    Morioka, 028-3695

    Recruiting

  • Shizuoka Cancer Center

    Nagaizumi-chō, 411-8777

    Recruiting

  • Nagasaki University Hospital

    Nagasaki, 852-8501

    Recruiting

  • Japan Community Healthcare Organization Chukyo Hospital

    Nagoya, 457-8510

    Recruiting

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001

    Recruiting

  • Nagoya University Hospital

    Nagoya, 466-8560

    Recruiting

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

    Recruiting

  • Hyogo Medical University Hospital

    Nishinomiya, 663-8501

    Recruiting

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute

    Osaka, 541-8567

    Recruiting

  • Saitama Prefectural Cancer Center

    Saitama, 362-0806

    Recruiting

  • NHO Kinki Chuo Chest Medical Center

    Sakai, 591-8555

    Recruiting

  • Teine Keijinkai Hospital

    Sapporo, 006-8555

    Recruiting

  • Sapporo Minamisanjo Hospital

    Sapporo, 060-0063

    Recruiting

  • Sendai Kousei Hospital

    Sendai, 981-0914

    Recruiting

  • Shibukawa Medical Center

    Shibukawa, 377-0280

    Recruiting

  • Toyama University Hospital

    Toyama, 930-0194

    Recruiting

  • Wakayama Medical University Hospital

    Wakayama, 641-8510

    Recruiting

  • Yokohama Municipal Citizen's Hospital

    Yokohama, 221-0855

    Recruiting

Other trials in Japan

Turkey (Türkiye)29 sites, 28 recruiting

  • Baskent Universitesi Tip Fakultesi Adana Hastanesi

    Adana, 1120

    Recruiting

  • Adana City Training and Research Hospital

    Adana, 1370

    Recruiting

  • Gulhane Training and Research Hospital

    Ankara, 06010

    Recruiting

  • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara, 06200

    Recruiting

  • Hacettepe University Medicine Faculty

    Ankara, 06230

    Recruiting

  • Memorial Ankara Hospital

    Ankara, 06520

    Recruiting

  • Liv Hospital Ankara

    Ankara, 06680

    Recruiting

  • Ankara Bilkent City Hospital

    Ankara, 06800

    Recruiting

  • Akdeniz University Hospital

    Antalya, 7985

    Recruiting

  • Dicle University Faculty of Medicine Hospital

    Diyarbakır, 21280

    Recruiting

  • Gaziantep Sanko University Medical Faculty

    Gaziantep, 36020

    Recruiting

  • Bezmialem Foundation University Medical Faculty

    Istanbul, 34093

    Recruiting

  • Istinye University Bahcesehir Liv Hospital

    Istanbul, 34517

    Recruiting

  • Yeditepe University Kosuyolu Hospital

    Istanbul, 34718

    Recruiting

  • Medical Point Izmir Hospital

    Izmir, 35325

    Recruiting

  • Goztepe Prof. Dr. Suleyman Yalcin City Hospital

    Kadıköy, 34722

    Recruiting

  • Ankara Ataturk Sanatoryum Saglik Uygulama ve Arastirma Merkezi

    Keçiören, 06290

    Recruiting

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380

    Recruiting

  • Necmettin Erbakan University Meram Medical Faculty

    Konya, 42080

    Recruiting

  • Medical Park Florya Hospital

    Küçükçekmece, 34295

    Recruiting

  • Medicalpark Ordu Hospital

    Ordu, 34752

    Recruiting

  • Karadeniz Technical University Faculty of Medicine

    Ortahisar, 61080

    Recruiting

  • Sakarya University - Faculty of Medicine

    Sakarya, 54290

    Recruiting

  • Ondokuz Mayis University Health Practice and Research Hospital

    Samsun, 55280

    Recruiting

  • Acibadem Adana Hospital

    Seyhan, 01130

    Withdrawn

  • Medical Park Seyhan Hospital

    Seyhan, 01170

    Recruiting

  • Mersin City Training and Research Hospital

    Toroslar, 33240

    Recruiting

  • Gazi University Faculty of Medicine

    Yenimahalle, 06560

    Recruiting

  • Koc Universitesi Hastanesi (Koc University Hospital)

    Zeytinburnu, 34010

    Recruiting

Other trials in Turkey (Türkiye)

France25 sites, 25 recruiting

  • Institut de Cancerologie de l'Ouest Paul Papin

    Angers, 49055

    Recruiting

  • Centre Hospitalier Universitaire d'Angers (CHU Angers)

    Angers, 49933

    Recruiting

  • Centre Hospitalier de la Cote Basque

    Bayonne, 64109

    Recruiting

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre

    Bordeaux, 33000

    Recruiting

  • Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    Bordeaux, 33076

    Recruiting

  • Hospices Civils de Lyon - Hopital Louis Pradel

    Bron, 69500

    Recruiting

  • CHU Caen Normandie

    Caen, 14033

    Recruiting

  • Centre Francois Baclesse

    Caen, 14076

    Recruiting

  • Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied

    Clermont-Ferrand, 63003

    Recruiting

  • Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.)

    Créteil, 94010

    Recruiting

  • Centre Hospitalier Universitaire De Grenoble- Hopital Albert Michallon

    La Tronche, 38700

    Recruiting

  • Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren

    Limoges, 87042

    Recruiting

  • Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse

    Lyon, 69004

    Recruiting

  • Institut Paoli-Calmettes

    Marseille, 13009

    Recruiting

  • GHRMSA Hopital Emile Muller

    Mulhouse, 68100

    Recruiting

  • Institut Curie - Centre de Recherche

    Paris, 75005

    Recruiting

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75013

    Recruiting

  • CIC Cochin Pasteur, Hopital Cochin

    Paris, 75014

    Recruiting

  • Hopital Lyon Sud

    Pierre-Bénite, 69310

    Recruiting

  • CHU de Rennes, Hopital de Pontchaillou

    Rennes, 35033

    Recruiting

  • Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau

    Saint-Herblain, 44805

    Recruiting

  • Centre Regional Lutte Contre Le Cancer Paul Strauss

    Strasbourg, 67200

    Recruiting

  • Hopital Foch

    Suresnes, 92151

    Recruiting

  • Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre

    Toulon, 83000

    Recruiting

  • Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP

    Villejuif, 94805

    Recruiting

Other trials in France

China24 sites, 24 recruiting

  • Affiliated Hospital of Hebei University

    Baoding, 071000

    Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, 100050

    Recruiting

  • Beijing Hospital

    Beijing, 100730

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, 100730

    Recruiting

  • Beijing Chest Hospital,Capital Medical University

    Beijing, 101149

    Recruiting

  • The First Affiliated Hospital Of Bengbu Medical College

    Bengbu, 233004

    Recruiting

  • Jilin Cancer Hospital

    Changchun, 130000

    Recruiting

  • Hunan Cancer Hospital

    Changsha, 410013

    Recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, 410013

    Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, 310016

    Recruiting

  • Zhejiang Medical University, Zhejiang Cancer Hospital

    Hangzhou, 310022

    Recruiting

  • Jiamusi Cancer Hospital

    Jiamusi, 154007

    Recruiting

  • Shandong University - Jinan Central Hospital

    Jinan, 250013

    Recruiting

  • Yunnan Provincial Cancer Hospital

    Kunming, 650118

    Recruiting

  • Jiangsu Peoples Hospital

    Nanjing, 210029

    Recruiting

  • Shanghai Chest Hospital

    Shanghai, 200030

    Recruiting

  • Fudan University - Shanghai Cancer Center (FUSCC)

    Shanghai, 200032

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

    Recruiting

  • Cancer Hospital of Shantou University Medical College

    Shantou, 515041

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215006

    Recruiting

  • Chongqing University Three Gorges Hospital

    Wanzhou, 404000

    Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, 430071

    Recruiting

  • Northern Jiangsu Peoples Hospital (NJPH)

    Yangzhou, 225001

    Recruiting

  • Taizhou Hospital of Zhejiang Province

    Zhejiang, 317000

    Recruiting

Other trials in China

Spain22 sites, 22 recruiting

  • CHUAC Hospital Teresa Herrera

    A Coruña, 15006

    Recruiting

  • Hospital Universitario de Badajoz

    Badajoz, 6006

    Recruiting

  • Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol

    Badalona, 08916

    Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals

    Barcelona, 8908

    Recruiting

  • Consorcio Hospitalario Provincial de Castellón

    Castellon, 12002

    Recruiting

  • Complejo Hospitalario Universitario Insular Materno Infantil

    Las Palmas de Gran Canaria, 35016

    Recruiting

  • Hospital Universitario De Leon

    León, 24080

    Recruiting

  • Hospital Universitari de Lleida Arnau de Villanova

    Lleida, 25198

    Recruiting

  • Hospital General Universitario Gregorio Maranon (HGUGM)

    Madrid, 28007

    Recruiting

  • Clinica MD Anderson International

    Madrid, 28033

    Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, 28222

    Recruiting

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, 38320

    Recruiting

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

    Recruiting

  • Hospital Universitario Nuestra Senora De Valme

    Seville, 41014

    Recruiting

  • Fundacion Instituto Valenciano de Oncologia

    Valencia, 46009

    Recruiting

  • Hospital General Universitario De Valencia

    Valencia, 46014

    Recruiting

  • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

    Valencia, 46026

    Recruiting

  • Hospital Alvaro Cunqueiro

    Vigo, 36312

    Recruiting

  • Hospital Universitario Miguel Servet de Zaragoza

    Zaragoza, 50009

    Recruiting

Other trials in Spain

Brazil20 sites, 20 recruiting

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    Barretos, 14784-400

    Recruiting

  • CIONC - Centro Integrado de Oncologia de Curitiba

    Curitiba, 81480-580

    Recruiting

  • Centro Regional Integrado de Oncologia

    Fortaleza, 60336-232

    Recruiting

  • Oncosite Centro De Pesquisa Clinica Em Oncologia

    Ijuí, 98700-000

    Recruiting

  • Clinica de Neoplasias Litoral LTDA / Catarina Pesquisa Clínica

    Itajaí, 88301-220

    Recruiting

  • Bruno Born Hospital

    Lajeado, 95900-000

    Recruiting

  • Instituto de Cancer de Londrina - Hospital do Cancer de Londrina - HCL

    Londrina, 86015-520

    Recruiting

  • Liga Norte Riograndense Contra o Cancer - CECAN

    Natal, 59062-000

    Recruiting

  • Hospital Sao Vicente de Paulo (HSVP)

    Passo Fundo, 99010-080

    Recruiting

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090

    Recruiting

  • Centro Gaucho Integrado de Oncologia e Hematologia - Hospital Mae de Deus/AESC

    Porto Alegre, 90110-270

    Recruiting

  • Centro Clinico do Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000

    Recruiting

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, 91350-200

    Recruiting

  • Oncoclinicas Rio de Janeiro S.A (Centro de Tratamento de Tumores Botafogo)

    Rio de Janeiro, 22250-905

    Recruiting

  • OC Oncoclínicas - Núcleo de Oncologia da Bahia-Ondina (OC Oncoclinicas-NOB Ondina)

    Salvador, 40170-110

    Recruiting

  • CEON Pesquisas

    São Caetano do Sul, 09541-270

    Recruiting

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base de Sao Jose do Rio Preto

    São José do Vale do Rio Preto, 15090-000

    Recruiting

  • IEP Sao Lucas Instituto de Ensino e Pesquisa Sao Lucas

    São Paulo, 01227-200

    Recruiting

  • IEP São Lucas

    São Paulo, 01227-959

    Recruiting

  • Associacao Feminina de Educacao e Combate ao Cancer(AFECC) - Hospital Santa Rita

    Vitória, 29043-260

    Recruiting

Other trials in Brazil

United Kingdom19 sites, 19 recruiting

  • Basildon University Hospital - Basildon And Thurrock University Hospitals Nhs Foundation Trust

    Basildon, SS16 5NL

    Recruiting

  • Royal United Hospital, Bath - Royal United Hospitals Bath NHS Foundation Trust

    Bath, BA1 3NG

    Recruiting

  • Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust

    Brighton, BN2 5BE

    Recruiting

  • Velindre NHS Trust, Velindre Cancer Centre

    Cardiff, CF14 2TL

    Recruiting

  • Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust

    Chelsea, SW3 6JJ

    Recruiting

  • Hull University Teaching Hospitals NHS Trust

    Cottingham, HU16 5JQ

    Recruiting

  • Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board

    Glasgow, G12 0YN

    Recruiting

  • Clatterbridge Cancer Centre

    Liverpool, L7 8YA

    Recruiting

  • University College Hospital

    London, NW2 1PG

    Recruiting

  • Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust

    London, SM2 5PT

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

    Recruiting

  • Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust

    Norwich, NR4 7UY

    Recruiting

  • Cancer And Haematology Centre-The Churchill Hospital-Oxford University Hospitals

    Oxford, OX3 7LJ

    Recruiting

  • Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust

    Preston, PR2 9HT

    Recruiting

  • Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S10 2SJ

    Recruiting

  • Southampton General Hospital

    Southampton, SO16 6YD

    Recruiting

  • Musgrove Park Hospital-Taunton & Somerset NHS Foundation Trust

    Taunton, TA1 5DA

    Recruiting

  • New Cross Hospital

    Wolverhampton, WV10 0QP

    Recruiting

  • York Teaching Hospital NHS Foundation Trust - The York Hospital

    York, YO31 8HE

    Recruiting

Other trials in United Kingdom

Germany18 sites, 18 recruiting

  • Uniklinik RWTH Aachen Medizinische Klinik IV

    Aachen, 52074

    Recruiting

  • Evangelische Lungenklinik Berlin

    Berlin, 13125

    Recruiting

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116

    Recruiting

  • Kaiserwerther Diakonie - Florence Nightingale Krankenhaus

    Düsseldorf, 40489

    Recruiting

  • Universitätsklinikum Erlangen

    Erlangen, 91054

    Recruiting

  • Klinikum Esslingen GmbH

    Esslingen am Neckar, 73730

    Recruiting

  • Asklepios Fachkliniken Muenchen Gauting

    Gauting, 82131

    Recruiting

  • SRH Wald-Kliniken Gera GmbH

    Gera, 07548

    Recruiting

  • Asklepios Klinik Harburg

    Hamburg, 21075

    Recruiting

  • Thoraxklinik-Heidelberg Ggmbh

    Heidelberg, 69126

    Recruiting

  • Lungenfachklinik Immenhausen - Pneumologische Lehrklinik der Universitaet Goettingen

    Immenhausen, 34376

    Recruiting

  • University Medical Center of Johannes Gutenberg-University Mainz

    Mainz, 55131

    Recruiting

  • Krankenhaus Bethanien Moers

    Moers, 47441

    Recruiting

  • Staedtisches Klinikum Muenchen Bogenhausen

    München, 81925

    Recruiting

  • MVZ for oncology and hematology Rhein-Kreis Neuss GmbH

    Neuss, 41462

    Recruiting

  • Onkologische Tagesklinik Remscheid

    Remscheid, 42853

    Recruiting

  • Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling

    Wesseling, 50389

    Recruiting

  • Helios Klinikum Wuppertal-Universitaet Witten-Herdecke

    Wuppertal, 42883

    Recruiting

Other trials in Germany

Poland18 sites, 18 recruiting

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-540

    Recruiting

  • In- Vivo Sp. z o. o.

    Bydgoszcz, 85-048

    Recruiting

  • Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii

    Gdansk, 80-211

    Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwicach

    Gliwice, 44-102

    Recruiting

  • Katowickie Centrum Onkologii

    Katowice, 40-074

    Recruiting

  • SPZOZ - Swietokrzyskie Centrum Onkologii

    Kielce, 25-734

    Recruiting

  • Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie

    Koszalin, 75-581

    Recruiting

  • FutureMeds Krakow

    Krakow, 31-501

    Recruiting

  • Instytut MSF Sp. z o.o.

    Lodz, 90-302

    Recruiting

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

    Lodz, 93-513

    Recruiting

  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie

    Lublin, 20-954

    Recruiting

  • Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie

    Olsztyn, 10-357

    Recruiting

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii

    Poznan, 60-101

    Recruiting

  • NZOZ Medpolonia Sp. Z o.o.

    Poznan, 60-693

    Recruiting

  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu

    Przemyśl, 37-700

    Recruiting

  • Narodowy Insytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781

    Recruiting

  • Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

    Warsaw, 04-349

    Recruiting

  • Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii

    Wroclaw, 53-413

    Recruiting

Other trials in Poland

Italy17 sites, 17 recruiting

  • Azienda Ospedaliera San Giuseppe Moscati

    Avellino, 83100

    Recruiting

  • Centro di Riferimento Oncologico

    Aviano, 33081

    Recruiting

  • Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi

    Bologna, 40138

    Recruiting

  • Istituto Candiolo IRCCS

    Candiolo, 10060

    Recruiting

  • Humanitas Istituto Clinico Catanese S.p.A

    Catania, 95045

    Recruiting

  • Azienda Ospedaliero - Universitaria di Ferrara

    Cona, 44124

    Recruiting

  • Azienda Socio Sanitaria Territoriale di Cremona (ASST Cremona)

    Cremona, 26100

    Recruiting

  • Ospedale San Luca

    Lucca, 55100

    Recruiting

  • IRCCS Istituto Romagnolo per lo studio dei Tumori Dino Amadori (IRST)

    Meldola, 47014

    Recruiting

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

    Milan, 20132

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Recruiting

  • UOC Oncoematologia AOU Luigi Vanvitelli

    Naples, 80131

    Recruiting

  • Casa Di Cura Polispecialistica Dott Pederzoli

    Peschiera del Garda, 37019

    Recruiting

  • Fondazione Policlinico Universitario Campus Bio-Medico

    Roma, 00128

    Recruiting

  • Istituti di Ricovero e Cura A Carattere Scientifico (IRCCS) - Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE)

    Roma, 00144

    Recruiting

  • Fondazione Ospedale Isola Tiberina - Gemelli Isola

    Rome, 00186

    Recruiting

  • Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte

    Siena, 53100

    Recruiting

Other trials in Italy

Australia15 sites, 14 recruiting

  • Cancer Research SA (CRSA)

    Adelaide, 5000

    Recruiting

  • Royal Adelaide Hospital

    Adelaide, 5000

    Recruiting

  • Flinders Medical Centre

    Bedford Park, 5042

    Recruiting

  • Cairns Hospital

    Cairns, 4870

    Recruiting

  • Dubbo Hospital

    Dubbo, 2830

    Recruiting

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, 3199

    Recruiting

  • Joondalup Health campus

    Joondalup, 6027

    Recruiting

  • Icon Cancer Centre Kurralta Park

    Kurralta Park, 5037

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

    Recruiting

  • Monash University - Monash Health -Monash Medical Centre

    Melbourne, 3168

    Recruiting

  • Central West Cancer Care Centre

    Orange, 2800

    Recruiting

  • Clinical Trial Center-Tasman Oncology Research Ltd

    Southport, 4216

    Recruiting

  • Western Health Sunshine Hospital

    St Albans, 3021

    Recruiting

  • ICON Cancer Care - Townsville

    Townsville, 4812

    Recruiting

  • Cancer Care Wollongong Pty Limited

    Wollongong, 2500

    Withdrawn

Other trials in Australia

Romania14 sites, 13 recruiting

  • Coltea Clinical Hospital

    Bucharest, 030171

    Recruiting

  • SC Gral Medical SRL

    Bucharest, 031424

    Recruiting

  • Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti (IOB)

    Bucharest, 22328

    Recruiting

  • Cardiomed

    Cluj-Napoca, 400015

    Recruiting

  • Oncology Institute Cluj-Napoca

    Cluj-Napoca, 400015

    Recruiting

  • S.C. Medisprof S.R.L, Oncologie medicala

    Cluj-Napoca, 400641

    Recruiting

  • Radiotherapy Center Cluj

    Cluj-Napoca, 407280

    Recruiting

  • Onco Clinic Consult SA

    Craiova, 200094

    Recruiting

  • Centrul de Oncologie Sf. Nectarie S.R.L (Sf Nectarie Oncology Center)

    Craiova, 200542

    Recruiting

  • Centrul de Oncologie Euroclinic srl

    Iași, 700106

    Recruiting

  • Institutul Regional De Oncologie Iasi

    Iași, 700483

    Recruiting

  • Ovidius Clinical Hospital

    Ovidiu, 905900

    Withdrawn

  • Municipal Hospital Ploiesti

    Ploieşti, 100337

    Recruiting

  • Oncomed

    Timișoara, 300239

    Recruiting

Other trials in Romania

South Korea12 sites, 12 recruiting

  • Chungbuk National University Hospital

    Cheongju-si, 28644

    Recruiting

  • Chungnam National University Hospital (CNUH)

    Daejeon, 35015

    Recruiting

  • National Cancer Center

    Goyang-si, 10408

    Recruiting

  • Gachon University Gil Medical Center

    Incheon, 21565

    Recruiting

  • Gyeongsang National University Hospital (GNUH)

    Jinju, 52727

    Recruiting

  • Seoul National University Bundang Hospital (SNUBH)

    Seongnam-si, 13620

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Recruiting

  • Asan Medical Center (AMC)

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • Korea University Guro Hospital

    Seoul, 08308

    Recruiting

  • The Catholic University Of Korea, St. Vincent's Hospital

    Suwon, 16247

    Recruiting

  • Ajou University Hospital

    Suwon, 16499

    Recruiting

Other trials in South Korea

Argentina7 sites, 7 recruiting

  • Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)

    Buenos Aires, C1113

    Recruiting

  • Instituto Argentino de Diagnóstico y Tratamiento (IADT)

    Buenos Aires, C1122

    Recruiting

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199

    Recruiting

  • Sanatorio Allende

    Córdoba, X5000JHQ

    Recruiting

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300

    Recruiting

  • Exelsus SRL

    San Miguel de Tucumán, 4000

    Recruiting

  • Centro de Investigaciones Clinicas. Clinica Viedma S. A

    Viedma, R8500

    Recruiting

Other trials in Argentina

Belgium6 sites, 6 recruiting

  • Universitair Ziekenhuis Gent (Uz Gent)

    Ghent, 9000

    Recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

    Recruiting

  • CHU HELORA, Hopital de Mons - Site Kennedy

    Mons, 7000

    Recruiting

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800

    Recruiting

  • VITAZ

    Sint-Niklaas, 9100

    Recruiting

  • Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert, 1200

    Recruiting

Other trials in Belgium

Thailand6 sites, 6 recruiting

  • Faculty of Medicine Vajira Hospital, Navamindradhiraj University

    Bangkok, 10300

    Recruiting

  • Chulalongkorn University

    Bangkok, 10330

    Recruiting

  • Chiangrai Prachanukroh Hospital

    Chiang Rai, 57000

    Recruiting

  • Lampang Cancer Hospital

    Lampang, 52000

    Recruiting

  • HRH Princess MahaChakri Sirindhorn Medical Center - Srinakharinwirot University

    Nakhon Nayok, 26120

    Recruiting

  • Rajavithi Hospital

    Ratchathewi, 10400

    Recruiting

Other trials in Thailand

Chile5 sites, 5 recruiting

  • Bradford Hill Norte

    Antofagasta, 1263521

    Recruiting

  • Clinica MEDS

    Lo Barnechea, 7691236

    Recruiting

  • Centro De Investigacion Clinica Bradford Hill

    Recoleta, 8420000

    Recruiting

  • Orlandi Oncologia

    Santiago, 7500713

    Recruiting

  • Centro de Estudios Clinicos e Investigaciones Medicas (CECIM)

    Santiago, 8331143

    Recruiting

Other trials in Chile

Georgia5 sites, 5 recruiting

  • High Technology Hospital Medcenter LTD

    Batumi, 6000

    Recruiting

  • LLC Todua Clinic

    Tbilisi, 0112

    Recruiting

  • LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

    Tbilisi, 0144

    Recruiting

  • New Hospitals

    Tbilisi, 0162

    Recruiting

  • Cancer Research Centre

    Tbilisi, 0179

    Recruiting

Other trials in Georgia

Hungary5 sites, 5 recruiting

  • Orszagos Onkologiai Intezet (National Institute of Oncology)

    Budapest, 1122

    Recruiting

  • Budapesti Uzsoki Utcai Korhaz

    Budapest, 1145

    Recruiting

  • Edelenyi Koch Robert Korhaz es Rendelointezet

    Edelény, 3780

    Recruiting

  • Bacs- Kiskun Varmegyei Oktatokorhaz Onkoradiologiai Kozpont

    Kecskemét, 6000

    Recruiting

  • Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointézet

    Szolnok, 5000

    Recruiting

Other trials in Hungary

Bulgaria4 sites, 4 recruiting

  • Complex Oncology Center

    Plovdiv, 4000

    Recruiting

  • Complex Oncological Center Ruse Ltd

    Rousse, 7000

    Recruiting

  • MHAT for Womens Health - Nadezhda OOD

    Sofia, 1373

    Recruiting

  • University Hospital Tsaritsa Yoanna - Isul (University Hospital Queen Giovanna)

    Sofia, 1527

    Recruiting

Other trials in Bulgaria

Switzerland3 sites, 3 recruiting

  • Kantonspital Baden

    Baden, 5404

    Recruiting

  • Centre Hospitalier Universitaire Vaudois Lausanne (CHUV) - Centre de transplantation d'organes (CTO)

    Lausanne, 1011

    Recruiting

  • Kantonsspital Münsterlingen

    Münsterlingen, 8596

    Recruiting

Other trials in Switzerland

About this study

Official title: 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.

Read the detailed description

Each substudy contains a Phase 2 part followed by a Phase 3 part. In the Phase 2 part, participants will be randomized to one of two dose levels of pumitamig (also known as BNT327, BMS-986545, or PM8002) plus chemotherapy (Arm 1 and Arm 2). In the Phase 3 part, participants will be randomized to pumitamig plus chemotherapy (Arm 3) or pembrolizumab plus chemotherapy (Arm 4). In China, additional participants will be enrolled into the Phase 2 part of each substudy to receive pumitamig plus chemotherapy (Arm 1A) to further evaluate the selected Phase 3 dose.

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 and will confirm the progression of disease, if applicable.

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

Keywords
First-line treatment, Combination with chemotherapy, Combination with other investigational agents, Bispecific antibody, Programmed death-ligand 1 (PD-L1), Vascular endothelial growth factor (VEGF) A, Immunotherapy, Programmed Death-1 monoclonal antibodies, Pumitamig, Lung cancer, BNT327, Carboplatin, Pemetrexed, Paclitaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06712316
Study groupRoleWhat they receive
Substudy A Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + PemetrexedExperimentalNot described
Receives: Drug: Pumitamig; Drug: Carboplatin; Drug: Pemetrexed
Substudy A Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + PemetrexedExperimentalNot described
Receives: Drug: Pumitamig; Drug: Carboplatin; Drug: Pemetrexed
Substudy A Phase 2 (Arm 1A - China only) - Pumitamig Dose 3 + Carboplatin + PemetrexedExperimentalNot described
Receives: Drug: Pumitamig; Drug: Carboplatin; Drug: Pemetrexed
Substudy A Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + PemetrexedExperimentalNot described
Receives: Drug: Pumitamig; Drug: Carboplatin; Drug: Pemetrexed
Substudy A Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + PemetrexedActive comparatorNot described
Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Pemetrexed
Substudy B Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + PaclitaxelExperimentalNot described
Receives: Drug: Pumitamig; Drug: Carboplatin; Drug: Paclitaxel
Substudy B Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + PaclitaxelExperimentalNot described
Receives: Drug: Pumitamig; Drug: Carboplatin; Drug: Paclitaxel
Substudy B Phase 2 (Arm 1A, China only) - Pumitamig Dose 3 + Carboplatin + PaclitaxelExperimentalNot described
Receives: Drug: Pumitamig; Drug: Carboplatin; Drug: Paclitaxel
Substudy B Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + PaclitaxelExperimentalNot described
Receives: Drug: Pumitamig; Drug: Carboplatin; Drug: Paclitaxel
Substudy B Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + PaclitaxelActive comparatorNot described
Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From the first dose of the investigational medicinal product (IMP) to the 90-day Follow-Up Visit

  2. Phase 2 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs)

    For substudies A and B.

    Measured: From the first dose of IMP to the 90-day Follow-Up Visit

  3. 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.

    Measured: Up to approximately 2 years

  4. 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.

    Measured: Up to approximately 2 years

  5. Phase 3 - Progression free survival (PFS) assessed by 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.

    Measured: Up to approximately 5 years

Secondary outcomes (18)

  1. Phase 3 - Overall survival (OS)

    For substudies A and B. OS defined as the time from randomization to death from any cause

    Measured: Up to approximately 5 years

  2. 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.

    Measured: Up to approximately 2 years

  3. 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.

    Measured: Up to approximately 2 years

  4. 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.

    Measured: Up to approximately 5 years

  5. 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.

    Measured: Up to approximately 2 years

  6. Phase 3 - PFS rate as assessed by BICR

    For substudies A and B.

    Measured: At 6, 12, and 18 months

  7. Phase 3 - PFS rate as assessed by investigator

    For substudies A and B.

    Measured: At 6, 12, and 18 months

  8. Phase 3 - OS rate

    For substudies A and B.

    Measured: At 6, 12, 18, 24 months

  9. 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).

    Measured: Up to approximately 5 years

  10. 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 (e.g., high score for functional scale is high/healthy level of functioning.

    Measured: Up to approximately 5 years

  11. 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.

    Measured: Up to approximately 5 years

  12. 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.

    Measured: Up to approximately 5 years

  13. 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.

    Measured: Up to approximately 5 years

  14. 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 (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.

    Measured: Up to approximately 5 years

  15. 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.

    Measured: Up to approximately 5 years

  16. 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.

    Measured: Up to approximately 5 years

  17. 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.

    Measured: From the first dose of IMP to the 90-day Follow-Up Visit

  18. Phase 3 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs)

    For substudies A and B.

    Measured: From the first dose of IMP to the 90-day Follow-Up Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2024
  2. Study start7 Jan 2025
  3. Primary completionJan 2029 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
1,580 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06712316
Sponsor's protocol ID
BNT327-06
Other IDs
2024-515764-31-00
Status last verified
Oct 2026
First submitted
11 Nov 2024
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Pumitamig, Pembrolizumab and Carboplatin in people with Non-small Cell Lung Cancer, run by BioNTech SE at 366 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 366 sites in United States, Japan, Turkey (Türkiye), France, China and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BioNTech clinical trials patient information (+49 6131 9084 ext. 0, patients@biontech.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: From the first dose of the investigational medicinal product (IMP) to the 90-day Follow-Up Visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06712316.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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