Evaluation of Repotrectinib and CYP450 Probe Cocktail in TKI-Pretreated ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

The primary objective of this study is to evaluate the efficacy and safety of **Repotrectinib** in patients with locally advanced or metastatic Tyrosine Kinase Inhibitors (TKI)-pretreated ROS1-positive **Non-small Cell Lung Cancer (NSCLC)**. This is clinically relevant as it addresses the need for effective treatment options in a patient population that has limited therapeutic alternatives due to prior TKI treatment. The study aims to assess the potential of Repotrectinib to provide clinical benefits in terms of tumor response and disease progression in this specific subset of NSCLC patients.

The clinical trial involves a total of **7 participants** diagnosed with **Non-small Cell Lung Cancer (NSCLC)**. The study population includes both male and female subjects, with an age range that spans from young adults to older adults. Participants were selected to include a vulnerable population, although specific inclusion or exclusion criteria were not provided. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The sponsor has not disclosed further details regarding the general health status of the participants or the specific selection process used for the trial population.

The clinical trial is designed to evaluate the efficacy and safety of **Repotrectinib** in combination with a CYP450 probe cocktail in patients with locally advanced or metastatic **Non-small Cell Lung Cancer (NSCLC)** who have been pretreated with tyrosine kinase inhibitors. This is a Phase 3, randomized, double-blind, controlled trial. The estimated recruitment start date is October 15, 2024, with an anticipated end date of July 31, 2028. The trial will involve multiple study visits, beginning with an inclusion visit where participants will be screened for eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive either the investigational treatment or a control. Regular follow-up visits will be scheduled to monitor the participants' health, assess treatment efficacy, and record any adverse events. The end-of-study visit will conclude the trial for each participant, during which final assessments will be conducted. The expected duration of participant involvement will vary depending on individual response to treatment and overall health status. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or any other medical reasons deemed necessary by the investigator. Participants will be closely monitored throughout the trial to ensure safety and adherence to the study protocol.

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 this data limits the ability to describe the treatments comprehensively.

Efficacy in this clinical trial will be assessed through a structured evaluation process. The trial is categorized as a Phase 3 study, indicating a focus on confirming the effectiveness of the intervention in a larger patient population. The trial is scheduled to commence recruitment on October 15, 2024, with an estimated completion date of July 31, 2028. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, Phase 3 trials typically involve comprehensive assessments to determine the intervention's impact on the disease. These assessments may include the use of validated scales, laboratory tests, and patient-reported outcomes to measure symptom improvement, biomarker levels, or disease remission rates. The data collected will be analyzed to evaluate the intervention's efficacy, ensuring that the results are scientifically robust and clinically meaningful.