Dose-Escalation Study of BI 764532 in Patients with DLL3-Positive Small Cell Lung Carcinoma and Neuroendocrine Neoplasms

The primary objective of this study is to evaluate the efficacy and safety of different doses of **BI 764532** in patients diagnosed with **Small Cell Lung Carcinoma** and other neuroendocrine neoplasms that express **DLL3**. This is clinically relevant as it aims to determine the optimal dosing regimen that maximizes therapeutic benefits while minimizing adverse effects in this patient population. The study does not specify any secondary objectives.

The clinical trial involves a total of **47 participants** diagnosed with **Small Cell Lung Carcinoma** and other neuroendocrine neoplasms expressing DLL3. The study population includes both male and female subjects, with an age range encompassing adults and older adults. Participants were selected without targeting any vulnerable populations. The general health status of the participants is not specified, and there are no specific lifestyle considerations such as diet or physical activity mentioned. The sponsor has not provided detailed information regarding the main objective of the trial or the principal inclusion criteria.

The clinical trial is designed to evaluate the efficacy and safety of varying doses of **BI 764532** in patients diagnosed with **Small Cell Lung Carcinoma** and other neuroendocrine neoplasms expressing DLL3. This study is structured as a Phase 1 trial, which is typically the initial phase in clinical research aimed at assessing the safety, tolerability, and optimal dosing of a new investigational drug. The trial employs a randomized, double-blind, and controlled design to ensure unbiased results and reliable data collection. The estimated recruitment start date was July 15, 2020, with an anticipated completion date of July 2, 2025, indicating a total trial duration of approximately five years.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. This initial visit will involve comprehensive assessments, including medical history review, physical examination, and laboratory tests. Following successful screening, participants will be randomized to receive different doses of the investigational drug. Throughout the trial, regular follow-up visits will be scheduled to monitor the participants' health status, evaluate drug efficacy, and record any adverse events. These visits are crucial for ensuring participant safety and collecting data on the drug's pharmacokinetics and pharmacodynamics.

The end-of-study visit will mark the conclusion of a participant's involvement in the trial. During this visit, final assessments will be conducted to gather data on the long-term effects of the treatment. The expected length of participant involvement will vary depending on individual response to the treatment and the occurrence of any adverse events. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or any other medical reasons deemed necessary by the investigator. The trial's design and procedures are meticulously planned to ensure the collection of high-quality data while prioritizing participant safety and well-being.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In terms of **non-experimental treatments**, the data does not include any information about the use of standard-of-care therapy, placebo, or comparator treatments within the study. There is no mention of any additional relevant information about drug administration, dosing schedules, or participant compliance monitoring. The absence of these details suggests that the trial documentation may be incomplete or that such information is not applicable to this particular study.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, with an estimated recruitment start date of July 15, 2020, and an estimated end date of July 2, 2025. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, Phase 1 trials typically focus on evaluating safety, tolerability, and pharmacokinetics, which may indirectly inform efficacy assessments. The trial will likely involve systematic data collection and analysis at predetermined intervals to monitor these parameters. The absence of explicit endpoints suggests that the trial may employ exploratory measures to gather preliminary efficacy data, potentially using validated scales or laboratory tests. The trial's design will adhere to rigorous standards to ensure the reliability and validity of the collected data, contributing to the overall assessment of the investigational product's efficacy.