RecruitingPhase I/II🇵🇱 PolandEN originalLung cancerMetastatic / advanced

A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with pumitamig (also known as BNT327 or PM8002) in participants with relapsed, progressive as well as treatment-naïve, advanced/metastatic non-small cell lung cancer (NSCLC). This study will enroll adult participants with histologically or cytologically confirmed NSCLC that is advanced (i.e., either metastatic or recurrent tumors with no known curative treatment available). The main goals of this study are: 1. To find the best dose levels (DLs) for the combination of BNT326 and pumitamig. 2. To look at how well participants with advanced NSCLC tolerate the combination therapy (for example, which side effects participants experience and how severe they are). 3. To look at how well the combination therapy works to shrink the tumor in participants with advanced NSCLC.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek co najmniej 18 lat
  • Zaawansowany rak płuca (rozprzestrzeniony na inne narządy lub powracający lokalnie)
  • Guz widoczny na badaniach obrazowych
  • Dobra sprawność fizyczna oceniana przez lekarza
  • Prawidłowe funkcje narządów wewnętrznych i szpiku kostnego
  • Wcześniejsze leczenie (1-3 linie terapii w przypadku choroby zaawansowanej)

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
August 5, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (85)

UCLA Hematology Oncology - Main Site

Los Angeles, United States

Stanford Cancer Institute

Stanford, United States

Yale University

New Haven, United States

Georgetown University - Lombardi Comprehensive Cancer Center

Washington D.C., United States

Moffit Cancer Center

Tampa, United States

Dana-Farber Cancer Institute

Boston, United States

Henry Ford Health System

Detroit, United States

Memorial Sloan Kettering Cancer Center

New York, United States

Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center

Cleveland, United States

University of Texas M. D. Anderson Cancer Center

Houston, United States

NEXT Virginia

Fairfax, United States

Cancer Research SA

Adelaide, Australia

St George Private Hospital

Kogarah, Australia

Royal North Shore Hospital

Saint Leonards, Australia

Mater

South Brisbane, Australia

John Flynn Private Hospital

Tugun, Australia

Westmead Hospital

Westmead, Australia

Affiliated Hospital of Hebei University

Baoding, China

Beijing GoBroad Hospital

Beijing, China

The First Hospital of Jilin University

Changchun, China

West China Hospital, Sichuan University

Chengdu, China

Chongqing University Cancer Hospital

Chongqing, China

Fujian Provincial Cancer Hospital

Fuzhou, China

The First Affiliated Hospital School of Clinical Medicine of Guangdong Pharmaceutical University

Guangzhou, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Anhui Chest Hospital

Hefei, China

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Anhui Provincial Cancer Hospital

Hefei, China

The Second Hospital of Anhui Medical University

Hefei, China

Jinan Central Hospital

Jinan, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

The Second Affiliated Hospital of Nanchang University

Nanchang, China

The Affiliated Hospital of Qingdao University

Qingdao, China

Shanghai East Hospital

Shanghai, China

Shanghai GoBroad Cancer Hospital

Shanghai, China

The First Affiliated Hospital of Soochow University

Suzhou, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Hubei Cancer Hospital

Wuhan, China

Xiangyang Central Hospital

Xiangyang, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, China

Xuzhou Central Hospital

Xuzhou, China

Northern Jiangsu People's Hospital

Yangzhou, China

Universitätsklinikum Carl Gustav Carus TU Dresden

Dresden, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Thoraxklinik Heidelberg gGmbH

Heidelberg, Germany

Azienda Ospedaliero - Universitaria Nazionale Santi Antonio e Biagio e Cesare Arrigo

Alessandria, Italy

Azienda Ospedaliero Universitaria Policlinico "Gaspare Rodolico - San Marco" (Presidio G. Rodolico)

Catania, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

IEO Istituto Europeo di Oncologia

Milan, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Institute of Oncology, ARENSIA Exploratory Medicine

Chisinau, Moldova

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Pratia MCM Krakow

Krakow, Poland

Centrum Medyczne Pratia Poznan

Poznan, Poland

Med-Polonia Sp. z o.o.

Poznan, Poland

Provita Prolife

Tomaszów Mazowiecki, Poland

Hospital Universitari Dexeus

Barcelona, Spain

Hospital Universitari Vall d'Hebron - VHIO

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario HM Madrid Sanchinarro

Madrid, Spain

Pratia ES Hospital Universitario de Torrejon

Madrid, Spain

Clinica Universidad de Navarra

Madrid, Spain

Hospital Quironsalud Malaga

Málaga, Spain

Clinica Universidad de Navarra

Pamplona, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Medical Park Seyhan Hospital

Adana, Turkey (Türkiye)

Adana City Hospital

Adana, Turkey (Türkiye)

Baskent University Adana Application and Research Center

Adana, Turkey (Türkiye)

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Oncology Research and Training Hospital, Clinical Research Center

Ankara, Turkey (Türkiye)

Gazi University Medical Faculty

Ankara, Turkey (Türkiye)

Ankara Memorial Hospital

Ankara, Turkey (Türkiye)

Memorial Antalya Hastanesi

Antalya, Turkey (Türkiye)

Yeditepe University Medical School Hospital

Istanbul, Turkey (Türkiye)

Koc University Hospital

Istanbul, Turkey (Türkiye)

Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

Mersin City Education and Research Hospital

Mersin, Turkey (Türkiye)

Sakarya Training and Research Hospital

Sakarya, Turkey (Türkiye)

Royal Free Hospital

London, United Kingdom

Royal Marsden Hospital

London, United Kingdom

Northern Centre for Cancer Care

Newcastle upon Tyne, United Kingdom

Royal Marsden Hospital-Sutton

Sutton, United Kingdom

Trial contact

BioNTech clinical trials patient information

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/6/2026.

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