Efficacy and Safety of Durvalumab and Novel Anti-Cancer Agents With/Without Chemotherapy in Treatment-Naïve Metastatic Non-Small Cell Lung Cancer

The primary objective of this study is to evaluate the **efficacy** and **safety** of Durvalumab and/or novel anti-cancer agents, with or without chemotherapy, in patients with previously untreated **Metastatic Non-Small Cell Lung Cancer (NSCLC)**. This is clinically relevant as it aims to determine the potential benefits and risks of these treatments in a population that has not yet received therapy, potentially offering new therapeutic options for managing this aggressive form of lung cancer.

The clinical trial involves a total of **125 participants** diagnosed with **Metastatic Non-Small Cell Lung Cancer (NSCLC)**. 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 criteria for vulnerability are not detailed. The trial does not specify particular lifestyle considerations such as diet, physical activity, or habits. The sponsor has not provided information regarding the main objective of the trial or the principal inclusion criteria.

The clinical trial is designed to evaluate the **efficacy** and safety of Durvalumab and/or novel anti-cancer agents, with or without chemotherapy, in patients with previously untreated **Metastatic Non-Small Cell Lung Cancer (NSCLC)**. This is a Phase 3, randomized, double-blind, controlled study. The trial commenced on December 7, 2018, and is estimated to conclude by March 26, 2026. Participants will be randomly assigned to receive either the investigational treatment or a control, ensuring that neither the participants nor the investigators know which treatment is being administered, thus maintaining 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 their response to the treatment and any adverse effects. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The end-of-study visit marks the conclusion of a participant's involvement, where final assessments are conducted to gather comprehensive data on the treatment's long-term effects.

The expected length of participant involvement in the trial is determined by the study protocol, which outlines the duration of treatment and follow-up periods. Participants may be subject to early termination from the study if they experience significant adverse effects, fail to comply with the study protocol, or withdraw consent. The trial's design and procedures are structured to ensure the collection of robust and reliable data, contributing to the understanding of the investigational treatment's potential benefits and risks in the target population.

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

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 treatments cannot be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the data. As such, these details cannot be elaborated upon in this context.

The clinical trial is a Phase 3 study, with an estimated recruitment start date of December 7, 2018, and an estimated end date of March 26, 2026. Efficacy will be assessed through a structured evaluation process, although specific parameters or endpoints for efficacy assessment are not detailed in the available data. The trial will follow a systematic approach to measure, collect, and analyze efficacy data, adhering to the standards expected in a Phase 3 clinical trial. The methods and schedule for these assessments are designed to ensure the reliability and validity of the results, although specific tools or instruments for efficacy assessments are not mentioned. The trial's design will likely include multiple timepoints for data collection to monitor changes over the course of the study, ensuring comprehensive evaluation of the treatment's efficacy.