Phase 1 Evaluation of Tarlatamab Safety, Tolerability, and Pharmacokinetics in Small Cell Lung Cancer Patients

The primary objective of this Phase 1 study is to evaluate the **safety**, **tolerability**, and **pharmacokinetics** of Tarlatamab in subjects with **Small Cell Lung Cancer**. This is clinically relevant as it aims to determine the initial safety profile and appropriate dosing parameters for Tarlatamab, which could potentially lead to new therapeutic options for patients with this aggressive form of lung cancer.

The clinical trial involves a total of **340 participants** diagnosed with **Small Cell Lung Cancer**. 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 a **Phase 1** study designed to evaluate the safety, tolerability, and pharmacokinetics of Tarlatamab in subjects diagnosed with **Small Cell Lung Cancer**. The trial employs a randomized, double-blind, and controlled design to ensure the reliability and validity of the results. The estimated duration of the trial spans from January 14, 2017, to October 21, 2025, allowing for comprehensive data collection and analysis over an extended period.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit is crucial for ensuring that only suitable candidates are enrolled in the study. Following the screening, participants will attend regular follow-up visits, which are scheduled to monitor their health status, assess the drug's effects, and collect necessary data. These visits are integral to maintaining participant safety and evaluating the trial's progress. The study will conclude with an end-of-study visit, where final assessments will be conducted to gather comprehensive data on the drug's impact and participant outcomes.

The expected length of participant involvement in the trial is contingent upon individual response to the treatment and adherence to the study protocol. Participants may be subject to early termination from the study if they experience adverse effects, fail to comply with the study requirements, or if the investigator deems it necessary for their safety. The trial's structured approach and rigorous monitoring aim to ensure the collection of high-quality data while prioritizing participant well-being throughout the study duration.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible with the given data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided data. As such, no further details can be included in this description.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, focusing on initial safety and efficacy assessments. The estimated recruitment start date was January 14, 2017, with an anticipated end date of October 21, 2025. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, typical Phase 1 trials often involve the collection of preliminary data on the drug's effects, which may include biomarker levels or symptom improvement scores. The methods for measuring and analyzing these parameters are not specified, but Phase 1 trials generally employ validated scales and laboratory tests to ensure accurate and reliable data collection. The trial's efficacy assessments are expected to be conducted at predetermined intervals throughout the study duration, aligning with standard clinical trial practices.