Study on BI 764532 for Patients with Relapsed or Refractory Small Cell Lung Cancer and Other Neuroendocrine Carcinomas

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called BI 764532 in patients with certain types of cancer. The cancers being studied include Small Cell Lung Cancer and other types of neuroendocrine carcinomas, which are cancers that can occur in different parts of the body and involve cells that release hormones into the blood. The treatment, BI 764532, is a special type of medication known as a T cell engager, which is designed to help the body’s immune system target and fight cancer cells more effectively.

The purpose of this study is to evaluate the safety and effectiveness of different doses of BI 764532 in patients whose cancer has returned or continued to grow after previous treatments. Participants in the study will receive the medication through an intravenous infusion, which means it will be given directly into a vein. The study will monitor how well the treatment works and any side effects that may occur. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

Throughout the study, participants will have regular check-ups and assessments to track their response to the treatment. The study aims to find the most effective dose of BI 764532 that can help manage these types of cancers while ensuring the safety of the participants. The trial will provide valuable information that could lead to new treatment options for patients with these challenging cancers.

1 joining the study

Upon joining the study, the patient will receive a detailed explanation of the trial, including its purpose and procedures. The patient must provide written informed consent to participate.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes verifying the type of cancer, previous treatments, and overall health status. The patient must have measurable lesions and adequate organ function.

3 treatment administration

The patient will receive the medication BI 764532 through an intravenous infusion. The dosage and frequency will be determined based on the specific needs of the patient and the trial’s protocol.

4 monitoring and follow-up

Throughout the trial, the patient will be monitored for any changes in their condition. This includes regular assessments of tumor response and any side effects experienced. The patient’s response to the treatment will be evaluated using specific criteria.

5 completion of treatment

Upon completion of the treatment phase, the patient will undergo a final assessment to determine the overall effectiveness of the treatment and any lasting effects.

6 post-trial follow-up

After the trial, the patient may be asked to participate in follow-up visits to monitor long-term outcomes and gather additional data on the treatment’s effects.

Who Can Join the Study?

Participants must be male or female and at least 18 years old. In some countries, they must be at the legal age of consent if it is higher than 18 years.
Participants need to sign a written informed consent form before joining the trial. This form shows they understand the trial and agree to participate.
Participants must have a confirmed diagnosis of one of the following types of cancer:
- Small Cell Lung Cancer (SCLC)
- Extra-pulmonary neuroendocrine carcinoma (epNEC), excluding certain types like Merkel cell carcinoma (MCC), medullary thyroid carcinoma (MTC), and neuroendocrine prostate cancer (NEPC)
- Large cell neuroendocrine carcinoma (LCNEC) of the lung
If the tumor has mixed types, the neuroendocrine or small cell component must be the main part, making up at least 50% of the tumor. Participants with SCLC must have had at least two previous treatments, including one with a platinum-based drug. Those with epNEC or LCNEC must have had at least one platinum-based treatment.
Participants should have an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1. This score measures how well they can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to do light work.
Participants must have measurable tumors as defined by specific guidelines within 21 days before the first dose of the trial medication.
Participants need to provide a sample of their tumor tissue from a previous biopsy.
Participants must have organs that are functioning well enough, as specified in the trial protocol.
Any side effects from previous cancer treatments should have improved to a mild level (Grade 1) before starting the trial treatment. Some exceptions are allowed for hair loss, nerve damage, tiredness, and hormone-related issues if they are at a moderate level (Grade 2) and menstrual issues of any severity.
Women who can have children and men who can father children must agree to use highly effective birth control methods that have a failure rate of less than 1% per year when used correctly. Details about these methods and how long to use them are provided in the trial information.

Who Cannot Join the Study?

Patients who have not experienced progression or recurrence of their cancer after at least two previous treatments, including one treatment with a platinum-based drug, cannot participate.
Patients with types of cancer not specified in the study, such as Merkel cell carcinoma (MCC), medullary thyroid carcinoma (MTC), or neuroendocrine prostate cancer (NEPC), are excluded.
Patients who have not had their cancer confirmed through specific medical tests called histology or cytology are not eligible.
Patients who have not experienced progression or recurrence after at least one treatment with a platinum-based drug are excluded.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country
Centre Hospitalier Intercommunal Creteil	Creteil	France
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Institut Gustave Roussy	Villejuif	France
Technische Universitaet Dresden	Dresden	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow	Poznan	Poland
Thoraxklinik Heidelberg gGmbH	Heidelberg	Germany
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Hospital Cuf Tejo S.A.	Lisbon	Portugal
Les Hopitaux Universitaires De Strasbourg	STRASBOURG, Alsace	France
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Asklepios Klinik Gauting GmbH	Gauting	Germany
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Universita Degli Studi Di Brescia	Brescia	Italy
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH	Berlin	Germany
LungenClinic Grosshansdorf GmbH	Grosshansdorf	Germany
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.	Panagyurishte	Bulgaria
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
Unidade Local De Saude De Matosinhos E.P.E.	Senhora Da Hora	Portugal
Hospital CUF Porto S.A.	Porto	Portugal
Ahrlqpzdwc Pbvkjnob Hqrzoiux De Ptubg	Paris	France
Apxfyjy Ovbqempiudz Ugdaiwlfymizx Pbbrz	Parma	Italy
Hfsmidqo Vuqs drjviull	Barcelona	Spain
Iztgwnkb Potsbhfteuxxczc Ccehzy Cmwghh	Marseille	France

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	13.10.2023
Bulgaria	Not recruiting	13.10.2023
France	Not recruiting	13.10.2023
Germany	Recruiting	13.10.2023
Italy	Not recruiting	13.10.2023
Poland	Not recruiting	13.10.2023
Portugal	Not recruiting	13.10.2023
Spain	Recruiting	13.10.2023

Trial locations

Investigated drugs:

BI 764532 is an experimental medication being tested in this clinical trial. It is designed to target a specific protein called DLL3, which is found on certain cancer cells. The medication works by engaging T cells, a type of immune cell, to attack and destroy these cancer cells. This trial is focused on patients with small cell lung cancer or other neuroendocrine carcinomas that have returned or worsened after previous treatments. The goal is to determine how safe and effective this medication is for these patients.

Investigated diseases:

Small Cell Lung Cancer – This is a fast-growing type of lung cancer that primarily originates in the bronchi, the main airways of the lungs. It is characterized by small cells that multiply quickly and form large tumors. The disease often spreads rapidly to other parts of the body, including the lymph nodes, liver, bones, and brain. Due to its aggressive nature, it is usually diagnosed at an advanced stage. The progression involves the rapid growth of cancerous cells, leading to significant health challenges.

Extra-pulmonary Neuroendocrine Carcinoma – This is a rare type of cancer that arises from neuroendocrine cells located outside the lungs. These cells have traits of both nerve and hormone-producing cells and can be found in various organs. The disease can develop in areas such as the gastrointestinal tract, pancreas, or skin. It is known for its aggressive behavior and potential to spread to other parts of the body. The progression involves the rapid multiplication of abnormal cells, which can lead to the formation of tumors in different organs.

Large Cell Neuroendocrine Carcinoma – This is a type of lung cancer that is part of the neuroendocrine tumor family. It is characterized by large, abnormal cells that grow and divide quickly. The disease often presents with symptoms similar to other lung cancers, such as coughing and difficulty breathing. It is known for its aggressive nature and tendency to spread to other parts of the body. The progression involves the rapid growth of cancerous cells, which can lead to significant health issues.

Trial ID:

2023-504247-13-00

Protocol code:

1438-0005

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on BI 764532 for Patients with Relapsed or Refractory Small Cell Lung Cancer and Other Neuroendocrine Carcinomas

What is this study about?

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