Phase I Study of BAY2927088 in Patients with Advanced Non-Small Cell Lung Cancer Harboring EGFR and/or HER2 Mutations

The primary objective of this study is to evaluate the safety and tolerability of **BAY2927088** in participants with advanced **non-small cell lung cancer (NSCLC)** who have mutations in the genes of **epidermal growth factor receptor (EGFR)** and/or **human epidermal growth factor receptor 2 (HER2)**. This is clinically relevant as it aims to address the therapeutic needs of patients with specific genetic mutations that may influence the progression and treatment response of NSCLC. The study does not specify any secondary objectives.

The clinical trial involves a total of **340 participants** diagnosed with **advanced non-small cell lung cancer**. 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 to include a vulnerable population, although specific inclusion or exclusion criteria were not provided by the sponsor. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The selection process aimed to encompass a diverse group of individuals to ensure comprehensive data collection and analysis.

The clinical trial is designed to evaluate the safety and efficacy of a novel investigational product in participants with **advanced non-small cell lung cancer** (NSCLC) characterized by mutations in the genes of epidermal growth factor receptor (EGFR) and/or human epidermal growth factor receptor 2 (HER2). The study follows a randomized, double-blind, controlled trial design, ensuring that neither the participants nor the investigators are aware of the treatment assignments, thereby minimizing bias. The trial is anticipated to span from October 20, 2022, to July 31, 2028, encompassing a comprehensive evaluation period.

Participants will undergo a series of structured study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a thorough review of the participant's medical history, physical examination, and necessary laboratory tests to confirm the presence of the specified genetic mutations. Following successful screening, participants will be randomized into treatment groups and commence the intervention phase.

Throughout the trial, participants will attend regular follow-up visits at specified intervals to monitor their response to the treatment and assess any adverse events. These visits will include clinical assessments, imaging studies, and laboratory evaluations to ensure participant safety and gather data on the investigational product's efficacy. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to evaluate the overall outcomes of the treatment.

The expected length of participant involvement in the trial is contingent upon the individual's response to the treatment and the absence of any adverse events that may necessitate early termination. Conditions that could lead to early withdrawal 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 to ensure the safety and well-being of all participants.

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 this study, there is no mention of any **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment being used. The data does not provide details on any additional relevant information about drug administration, dosing schedules, or participant compliance monitoring. The absence of these details suggests that the trial documentation may be incomplete or that such information is not applicable to this particular study.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is set to conclude by July 31, 2028, with recruitment having commenced on October 20, 2022. The trial is categorized under phase 7, indicating a specific stage in the clinical research process. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, the trial will likely employ standard methodologies for measuring and analyzing efficacy outcomes. These may include validated scales, laboratory tests, or patient-reported outcomes, assessed at predetermined timepoints throughout the trial duration. The absence of explicit endpoints suggests that the trial may focus on a broad range of efficacy indicators, potentially encompassing symptom improvement, biomarker levels, or disease remission rates. The trial's design will ensure that data collection and analysis adhere to rigorous scientific standards, facilitating a comprehensive evaluation of the treatment's efficacy.