A study to evaluate the safety and effectiveness of BNT324 and BNT327 in patients with advanced lung cancer

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What is this study about?

This study focuses on individuals with Advanced Lung Cancer, which includes types such as Non-Small Cell Lung Cancer and Small Cell Lung Cancer. The research aims to investigate the efficacy and safety of a combination therapy using two experimental drugs, BNT324 and BNT327. These medications are administered through an intravenous infusion, which is a method of delivering fluids or medicine directly into a vein.

The study is divided into two parts to determine the best way to use these medicines. In the first part, different amounts of the drugs are given to find the safest and most effective dose. The second part focuses on finding the optimal dose and observing how well the combination works for different types of lung cancer. Throughout the process, the safety and how the body processes the drugs are closely monitored.

Who Can Join the Study?

You must be at least 18 years old when you agree to join the study.
You must have advanced or metastatic lung cancer, which means the cancer is in an advanced stage or has spread to other parts of the body, and it cannot be removed by surgery.
Your cancer type must be confirmed through histology (looking at tissue samples under a microscope) or cytology (looking at individual cells under a microscope).
If you have non-small cell lung cancer (NSCLC), you can participate regardless of your PD-L1 expression, which is a protein found on some cancer cells that helps them hide from the immune system.
If you have AGA-positive disease, you must have already received targeted therapy, which is a type of treatment designed to attack specific molecules involved in cancer growth.
Your cancer must be measurable, meaning the tumors are large enough to be clearly seen and tracked using standard medical imaging rules known as RECIST.
You must have a performance status of 0 or 1, according to the Eastern Cooperative Oncology Group (ECOG) scale; this is a system used to measure how well you can perform daily activities and your overall physical health.
You are expected to have a life expectancy of at least 12 weeks.

Who Cannot Join the Study?

You have previously received treatment using B7-H3 targeted therapy, which is a type of medicine designed to attack a specific protein found on some cancer cells.
You have previously used an ADC with a topoisomerase inhibitor, which is a specialized drug that uses a “carrier” to deliver a strong chemical that stops cancer cells from multiplying. This rule applies specifically to patients who have not yet received treatment for their advanced or spreading cancer.
You are considered a candidate for locoregional treatment, which means treatments like surgery, specialized radiation, or procedures to destroy a tumor that aim to completely remove or control the cancer in one specific area.
You have a history of significant hematologic toxicity, which means your previous medical treatments caused serious damage to your blood cells.
You have experienced Grade 4 febrile neutropenia, which is a very severe condition where you have a very low count of white blood cells (the cells that fight infection) and also have a fever.
You have experienced recurrent or persistent Grade 3 to 4 neutropenia, which refers to a continuous or repeated low level of white blood cells that is considered severe.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Centre Hospitalier Intercommunal Creteil	Creteil	France
Oncopole Claudius Regaud	Toulouse	France
Comite Entreprise Paul Papin	Angers	France

Other Sites

Site Name	City	Country
Hospital Foch	Suresnes	France
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Hospital Quironsalud Malaga	Malaga	Spain
Pratia Hematologia Sp. z o.o.	Katowice	Poland
Ospedale San Raffaele S.r.l.	Milan	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Virgen De Valme	Sevilla	Spain
Pratia S.A.	Skorzewo	Poland
Hopital Beaujon	Clichy	France
Zmwjdal Mhvbhyc Cyozls Sgr z ozmm	Lublin	Poland
Ifzatv Ibwgyrfr Fekdyepfjdtij Ovvgvldegeh	Rome	Italy
Ahmdhvuaox Poaveaae Hqsomdkp Db Mhjwaiqts	Marseille	France
Uxexpdcywykqyf Cvfzycr Kogzqusti	Gdansk	Poland
Hoomycyc Vxse ddhpfasj	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.03.2026
Italy	Recruiting	15.03.2026
Poland	Recruiting	15.03.2026
Spain	Recruiting	15.03.2026

Trial locations

BNT324 is an experimental therapy being tested to see how well it works and how safe it is when used to treat advanced lung cancer.

BNT327 is an experimental therapy that is being studied in combination with another medication to evaluate its effectiveness and safety in patients with advanced lung cancer.

Non-small cell lung cancer – This is a type of cancer that starts in the cells of the lungs. It is the most common form of lung cancer and typically develops in the outer parts of the lungs. The disease often begins as a mass of abnormal cells that can grow and spread to nearby tissues. As it progresses, the cancer cells may move to other parts of the body through the blood or lymph system. It can present in different forms, such as adenocarcinoma or squamous cell carcinoma.

Small cell lung cancer – This is a specific type of lung cancer that is characterized by the rapid growth of abnormal cells. It often starts in the center of the lungs near the large airways. The disease typically progresses quickly and is known for its tendency to spread to other organs early on. It is categorized by the presence of small, round cells when viewed under a microscope.

Trial ID:

2024-520238-31-01

Protocol code:

BNT324-01

NCT ID:

NCT06892548

Trial Phase:

Human Pharmacology (Phase I) – Other

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A study to evaluate the safety and effectiveness of BNT324 and BNT327 in patients with advanced lung cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?