Evaluation of BI 764532 in Combination with Standard of Care for Tolerability in Patients with Extensive-Stage Small Cell Lung Carcinoma

The primary objective of this study is to evaluate the **tolerability** of different doses of BI 764532 in combination with standard of care in individuals diagnosed with **extensive-stage small cell lung carcinoma (ES-SCLC)**. This is clinically relevant as it aims to determine the optimal dosing regimen that can be safely administered to patients, potentially improving therapeutic outcomes and minimizing adverse effects in this aggressive form of lung cancer.

The clinical trial involves a total of **14 participants** diagnosed with **extensive-stage small cell lung carcinoma (ES-SCLC)**. The study population includes both male and female subjects, with an age range that spans from adults to the elderly. Participants were selected without targeting any vulnerable populations. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The sponsor has not provided detailed information regarding the main objective of the trial or specific inclusion criteria. The selection process aimed to ensure a representative sample of individuals affected by this condition, without imposing additional lifestyle restrictions.

The clinical trial is designed to evaluate the tolerability of different doses of **BI 764532** in combination with standard care for individuals diagnosed with **extensive-stage small cell lung carcinoma (ES-SCLC)**. This study is structured as a Phase 3, randomized, double-blind, controlled trial. The estimated duration of the trial spans from December 1, 2023, to June 25, 2026. Participants will be randomly assigned to receive either the investigational drug or a placebo, in addition to the standard treatment regimen, ensuring that neither the participants nor the investigators are aware of the group assignments to maintain the integrity of the data.

The sequence of study visits begins with an inclusion visit, also known as the screening visit, where potential participants are assessed for eligibility based on predefined criteria. Following successful enrollment, participants will attend regular follow-up visits at specified intervals to monitor their health status, assess the drug's effects, and ensure adherence to the study protocol. These visits will include comprehensive evaluations such as physical examinations, laboratory tests, and imaging studies as necessary. The end-of-study visit marks the conclusion of the participant's involvement, where final assessments are conducted to gather data on the long-term effects and safety of the treatment.

The expected length of participant involvement in the trial is approximately 30 months, contingent upon individual response and adherence to the study protocol. Conditions that may lead to early termination from the study include adverse reactions to the investigational drug, withdrawal of consent, or any significant protocol deviations. Participants will be closely monitored throughout the trial to ensure their safety and well-being, with provisions in place to address any medical concerns that arise during the study period.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the **experimental medication**, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available. Additionally, details about drug administration, dosing schedules, and participant compliance monitoring are not included in the source data. Consequently, no further information can be offered regarding the substances used in this study.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on December 1, 2023, with an estimated completion date of June 25, 2026. The efficacy assessment will be conducted through a series of pre-defined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured protocol to ensure the collection and analysis of efficacy data is consistent and reliable throughout the study duration. The trial's design and execution will adhere to the rigorous standards expected in a Phase 3 clinical trial, focusing on the evaluation of treatment efficacy in a controlled and scientifically valid manner.