Evaluation of Trastuzumab Deruxtecan and Pembrolizumab in Patients with Locally Advanced or Metastatic Breast Cancer or Non-Small Cell Lung Cancer

The primary objective of this study is to evaluate the efficacy and safety of **Trastuzumab Deruxtecan** and **Pembrolizumab** in participants with **locally advanced/metastatic breast cancer** or **non-small cell lung cancer**. This is clinically relevant as these cancers represent significant health burdens, and the combination of these therapies may offer a novel treatment approach that could improve patient outcomes. The study aims to determine the potential benefits and risks associated with this combination therapy in the specified patient population.

The clinical trial involves a total of **38 participants** diagnosed with **locally advanced/metastatic breast or non-small cell lung cancer**. The study population includes both male and female subjects, with an age range spanning from 18 to 64 years. 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 and exclusion criteria.

The clinical trial is designed to evaluate the efficacy and safety of **trastuzumab deruxtecan** and **pembrolizumab** in participants with **locally advanced or metastatic breast cancer** or **non-small cell lung cancer**. This is a Phase 3, randomized, double-blind, controlled trial. The trial commenced on April 24, 2020, and is estimated to conclude on November 6, 2025. Participants will be randomly assigned to receive either the investigational treatment or a control, with neither the participants nor the investigators aware of the group assignments, ensuring the double-blind nature of the study.

The sequence of study visits begins with an inclusion visit, where potential participants undergo screening to determine eligibility based on predefined criteria. Following successful screening, participants will be enrolled and begin the treatment phase. Throughout the trial, participants will attend regular follow-up visits to monitor their health status, assess treatment efficacy, and record any adverse events. These visits are crucial for collecting data on primary and secondary endpoints, although specific endpoints are not detailed in the available data. The trial will conclude with an end-of-study visit, where final assessments are conducted, and participants are debriefed.

The expected length of participant involvement varies depending on individual response to treatment and overall health status, but it is anticipated to span several months. Conditions that may lead to early termination from the study include significant adverse reactions, disease progression, or withdrawal of consent by the participant. The trial is conducted in accordance with ethical guidelines and regulatory requirements, ensuring the safety and well-being of all participants throughout the study duration.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of these details limits the ability to describe the treatment regimen comprehensively.

The clinical trial is in Phase 3, with an estimated recruitment start date of April 24, 2020, and an estimated end date of November 6, 2025. Efficacy will be assessed through the evaluation of primary and secondary endpoints, although specific endpoints are not detailed in the provided data. The trial will follow a structured schedule for measuring and collecting efficacy parameters, which is typical for Phase 3 trials, but specific timepoints and methods are not specified. The analysis of these parameters will be conducted using standard clinical trial methodologies appropriate for the trial phase and category. The trial's objective is to determine the efficacy of the intervention, but further details on the endpoints or assessment tools are not available in the provided information.