Evaluation of BI 764532 Uptake in Tumors of Patients with Large Cell Neuroendocrine Lung Carcinoma, Neuroendocrine Carcinoma, or Small Cell Lung Carcinoma

The primary objective of this study is to evaluate the uptake of **BI 764532** by tumors in individuals diagnosed with **small cell lung carcinoma (SCLC)**, **large cells neuroendocrine lung carcinoma (LCNEC)**, or **neuroendocrine carcinoma (NEC)** of any other origin. Understanding the uptake of this investigational drug is clinically relevant as it may provide insights into its potential efficacy and inform future therapeutic strategies for these aggressive cancer types.

The clinical trial involves participants diagnosed with **large cell neuroendocrine lung carcinoma (LCNEC)**, neuroendocrine carcinoma (NEC) or small cell carcinoma of any other origin, and small cell lung carcinoma (SCLC). The study population includes both male and female subjects, with an age range that encompasses adults and older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria for the trial population, as well as any relevant lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. Key inclusion or exclusion criteria are also not specified in the available data.

The clinical trial is designed to evaluate the uptake of **BI 764532** in tumors of individuals diagnosed with **small cell lung carcinoma (SCLC)**, **large cells neuroendocrine lung carcinoma (LCNEC)**, or **neuroendocrine carcinoma (NEC)**. This study is a Phase 3, randomized, double-blind, controlled trial, with an estimated recruitment start date of August 24, 2023, and an anticipated completion date of July 25, 2026. The trial will involve multiple study visits, beginning with an inclusion visit where participants will be screened for eligibility based on specific inclusion and exclusion criteria. Following successful screening, participants will be randomized to receive either the investigational product or a control, with neither the participants nor the investigators aware of the group assignments to maintain blinding.

Participants will be required to attend regular follow-up visits throughout the study duration to monitor the drug's uptake and assess any adverse effects. These visits will include various assessments such as imaging studies, laboratory tests, and clinical evaluations to ensure participant safety and gather data on the drug's efficacy. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to evaluate the overall outcomes of the treatment. The expected length of participant involvement will vary depending on individual response and tolerance to the treatment, but it is anticipated to last until the study's completion in 2026.

Participants may be subject to early termination from the study if they experience significant adverse effects, fail to comply with study procedures, or if the study is discontinued for any reason. The trial's design and procedures are structured to ensure the collection of robust and reliable data while prioritizing participant safety and adherence to ethical standards. The study aims to provide valuable insights into the treatment of these rare and challenging cancer types, contributing to the advancement of therapeutic options for affected individuals.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these treatments can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be offered regarding these aspects of the clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on August 24, 2023, with an estimated completion date of July 25, 2026. The efficacy assessment will be conducted through a series of predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis throughout the study period. The focus will be on evaluating the treatment's impact on the specified medical condition, utilizing appropriate clinical methodologies and tools as per standard Phase 3 trial protocols. The trial's design and execution will adhere to rigorous scientific standards to ensure the reliability and validity of the efficacy outcomes.