Phase I/IIa Study of Inhaled CIS-DPI as Adjunctive Therapy in Stage IV Non-Small Cell Lung Cancer Patients

The primary objective of this study is to evaluate the safety and tolerability of inhaled **CIS-DPI** as an add-on treatment in patients with Stage IV **Non-Small Cell Lung Cancer** (NSCLC). This is a first-in-human phase I/IIa study, which is crucial for determining the potential of CIS-DPI to enhance current treatment regimens for advanced NSCLC. Understanding the safety profile and tolerability of this novel inhaled therapy is essential for its future development and potential integration into clinical practice for managing Stage IV NSCLC.

The clinical trial focuses on participants diagnosed with **Non-Small Cell Lung Cancer**. The study population includes both male and female subjects, with an age range that encompasses adults and older adults. The trial does not specifically target a vulnerable population. However, the sponsor has not provided information regarding the total number of participants involved in the study. The selection criteria for the trial population, as well as any lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. Key inclusion or exclusion criteria, if any, are also not specified by the sponsor.

The clinical trial is designed to evaluate the safety and efficacy of an investigational inhaled treatment as an add-on therapy for patients with **Non-Small Cell Lung Cancer** (NSCLC) at Stage IV. This study is structured as a first-in-human, phase I/IIa trial, employing a randomized, double-blind, and controlled methodology to ensure the reliability and validity of the results. The trial is expected to span approximately four years, with an estimated recruitment start date of December 27, 2022, and an anticipated completion date of October 30, 2026.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, to assess eligibility based on predefined criteria. Following successful inclusion, participants will be randomized into treatment groups. The trial will include multiple follow-up visits to monitor the participants' response to the treatment and to collect data on safety and efficacy. These visits are crucial for assessing the primary and secondary endpoints of the study. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to gather comprehensive data on the treatment's impact.

The expected duration of participant involvement will vary depending on individual response and the specific phase of the trial they are enrolled in. Participants may be subject to early termination from the study if they experience adverse effects that compromise their safety, if they withdraw consent, or if they fail to comply with the study protocol. The trial is conducted under strict ethical guidelines, ensuring that participant welfare is prioritized throughout the study duration.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the absence of specific details, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be included. The data does not contain any information about the pharmaceutical form, maximum daily dose, maximum total dose, or maximum treatment period of the experimental medication. Furthermore, there is no information regarding whether the formulation is pediatric or if it is classified as an **orphan drug**.

As the source data lacks comprehensive details about the trial's treatments, this description remains limited to the information provided. Any further elaboration on the substances involved in the trial is not possible without additional data.

The clinical trial is scheduled to have an estimated recruitment start date of December 27, 2022, and an estimated end date of October 30, 2026. The trial is categorized under phase 7, indicating an advanced stage of clinical research. Efficacy assessments will be conducted throughout the trial period, although specific parameters or endpoints for evaluating efficacy, such as symptom improvement scores or biomarker levels, are not detailed in the available data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters are also not specified. The trial's primary and secondary endpoints remain unspecified, and no tools or instruments for efficacy assessments are mentioned. The trial's focus on a particular medical condition is not provided, and the main objective of the trial is not detailed in the available information.