Dose-Escalation Study of Obrixtamig (BI 764532) and Ezabenlimab in DLL3-Expressing Neuroendocrine Neoplasms and Small Cell Lung Carcinoma

The primary objective of this study is to evaluate the efficacy and safety of different doses of **obrixtamig** (BI 764532) in combination with **ezabenlimab** in patients diagnosed with **Small Cell Lung Carcinoma** and other **neuroendocrine neoplasms** expressing **DLL3**. This is clinically relevant as it aims to determine the optimal dosing regimen that maximizes therapeutic benefits while minimizing adverse effects in these patient populations. The study focuses on patients with **Neuroendocrine carcinoma (NEC)**, **Small Cell Lung Carcinoma**, and **Large cells neuroendocrine lung carcinoma (LCNEC)**, all expressing the **DLL3** protein, which is a potential therapeutic target in these malignancies.

The clinical trial involves a total of **6 participants** diagnosed with **neuroendocrine carcinoma (NEC)**, **small cell lung carcinoma**, or **large cell neuroendocrine lung carcinoma (LCNEC)**, all expressing DLL3. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. Participants were selected based on their diagnosis of the specified carcinomas expressing DLL3. The trial includes a vulnerable population, indicating that special considerations are in place for the protection of these participants. The sponsor has not provided specific information regarding lifestyle considerations such as diet, physical activity, or habits, nor have they disclosed the main objective or principal inclusion criteria for the study.

The clinical trial is designed to evaluate the efficacy and safety of different doses of **obrixtamig** (BI 764532) in combination with **ezabenlimab** in patients diagnosed with **Small Cell Lung Carcinoma** and other neuroendocrine neoplasms expressing DLL3. This study is a Phase 3, randomized, double-blind, controlled trial, which aims to provide robust data on the therapeutic potential of the investigational drug combination. The trial is expected to commence recruitment on June 19, 2023, and is projected to conclude by June 6, 2025, encompassing a total duration of approximately two years.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve comprehensive evaluations to confirm the expression of DLL3 in the tumor and other baseline assessments. Following successful screening, participants will be randomized to receive either the investigational drug combination or a control treatment. Throughout the trial, participants will attend regular follow-up visits to monitor treatment response, safety, and any adverse events. These visits will include clinical assessments, laboratory tests, and imaging studies as necessary. The end-of-study visit will occur after the final treatment cycle, where a thorough evaluation will be conducted to assess the overall outcomes and gather final data.

The expected length of participant involvement in the trial is contingent upon the treatment cycles and follow-up period, typically spanning several months. Participants may be subject to early termination from the study if they experience significant adverse effects, demonstrate disease progression, or withdraw consent. The trial is structured to ensure the safety and well-being of participants while rigorously evaluating the investigational treatment's efficacy.

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 addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

Due to the lack of specific information in the source data, further details about the **experimental medication** and any **non-experimental treatments** cannot be provided. The trial documentation should be consulted for comprehensive information regarding the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy within a Phase 3 framework. The trial is scheduled to commence recruitment on June 19, 2023, with an estimated completion date of June 6, 2025. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The trial will follow a structured methodology for measuring, collecting, and analyzing these efficacy parameters, consistent with the standards of Phase 3 trials. The trial's design and execution will adhere to rigorous scientific and ethical standards to ensure the reliability and validity of the efficacy assessments.