RecruitingPhase 1Phase 2NCT07111520

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)

A Phase Ib/II, Multi-site, Open-label, Dose Finding Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT326 in Combination With BNT327 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)

Sponsor

BioNTech SE

Enrollment

420 participants

Start Date

Sep 22, 2025

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

Summary

This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with BNT327 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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination treatment using BNT326 and BNT323 — two antibody-drug conjugates that deliver chemotherapy directly to cancer cells — for people with advanced non-small cell lung cancer (NSCLC). Different combinations and patient groups are being studied across multiple treatment parts. **You may be eligible if...** - You are 18 years or older with advanced (metastatic or locally recurrent) non-small cell lung cancer that cannot be treated with curative intent - You have measurable disease on imaging - Your physical condition is good (ECOG 0-1) - Your organ function meets required levels - Tumor tissue is available for testing - Depending on the cohort: you may need to have progressed on prior therapy, or have specific genetic markers **You may NOT be eligible if...** - You have active brain metastases requiring treatment - You have had prior treatment with the specific drugs being tested - You have significant heart, lung, or autoimmune conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBNT326

intravenous (IV) infusion

DRUGBNT327

IV infusion

DRUGPembrolizumab

IV infusion

DRUGSoC

IV infusion. Combination chemotherapy (pemetrexed, paclitaxel, or carboplatin). Chemotherapy will be selected according to the indication.

Locations(68)

Stanford Cancer Institute

Stanford, California, United States

Yale University

New Haven, Connecticut, United States

Moffit Cancer Center

Tampa, Florida, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center

Cleveland, Ohio, United States

University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

NEXT Virginia

Fairfax, Virginia, United States

Cancer Research SA

Adelaide, Australia

St George Private Hospital

Kogarah, 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

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

Northern Jiangsu People's Hospital

Yangzhou, China

Universitätsklinikum Carl Gustav Carus TU Dresden

Dresden, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

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

Alessandria, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Institute of Oncology, ARENSIA Exploratory Medicine

Chisinau, Moldova

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 Clinic de Barcelona

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario HM Madrid Sanchinarro

Madrid, Spain

Clinica Universidad de Navarra

Madrid, Spain

Hospital Quironsalud Malaga

Málaga, Spain

Hospital Universitario Virgen Macarena

Seville, 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07111520

Related Trials

Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols

NCT026826671 location

Vebreltinib Plus Furmonertinib in Patients With EGFR-mutated Advanced Non-small Cell Lung Cancer and High PD-L1 Expression

NCT076556221 location

A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors

NCT0646506934 locations

MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)

NCT0743182756 locations

MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

NCT0658651552 locations