Evaluation of Debio 0123 Combined with Carboplatin and Etoposide in Adults with Recurrent or Progressive Small Cell Lung Cancer Post-Platinum Therapy

The primary objective of this study is to evaluate the efficacy and safety of **Debio 0123** in combination with carboplatin and etoposide in adult participants with **small cell lung cancer** that has recurred or progressed following platinum-based therapy. This is clinically relevant as small cell lung cancer is an aggressive form of lung cancer with limited treatment options after initial therapy failure, and the study aims to provide insights into potential new therapeutic strategies.

The clinical trial involves a total of **28 participants** diagnosed with **small cell lung cancer**. The study population includes both male and female subjects, with an age range that encompasses 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 ensure a representative sample of individuals affected by this condition, without further details on the health status or lifestyle factors of the participants.

The clinical trial is designed to evaluate the efficacy and safety of **Debio 0123** in combination with carboplatin and etoposide in adult participants with **small cell lung cancer** that has recurred or progressed following platinum-based therapy. This study is a Phase 3, randomized, double-blind, controlled trial. The estimated recruitment start date is May 2, 2023, with an anticipated end date of May 11, 2027, indicating a total trial duration of approximately four years. 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 (screening) visit, where potential participants are assessed for eligibility based on predefined criteria. Following successful screening, participants will undergo a series of follow-up visits at regular intervals to monitor treatment response, safety, and any adverse events. These visits will include clinical assessments, laboratory tests, and imaging studies as necessary. The end-of-study visit will occur after the completion of the treatment period, where final evaluations will be conducted to assess the overall outcomes of the trial.

Participant involvement is expected to last for the duration of the treatment period plus any additional follow-up required by the study protocol. Conditions that may lead to early termination from the study include significant adverse events, withdrawal of consent, or any other medical reasons deemed necessary by the investigator. 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 addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

Due to the lack of specific information, further details about the **experimental medication** and any **non-experimental treatments** used in the study cannot be provided. The trial documentation does not include any additional relevant information about drug administration or participant compliance monitoring.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on May 2, 2023, with an estimated completion date of May 11, 2027. The efficacy assessment will be conducted through a series of planned evaluations, although specific parameters or endpoints for efficacy evaluation are not detailed in the provided data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The methods and tools for measuring efficacy, as well as the specific timepoints for these assessments, are not specified in the available information. The trial's focus on efficacy is aligned with the objectives typical of a Phase 3 study, which generally aims to confirm the effectiveness of a treatment in a larger patient population. The trial's design and execution will adhere to rigorous standards to ensure the reliability and validity of the efficacy data collected.