Comparative Study of Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 and Pembrolizumab in Advanced/Metastatic Non-Squamous NSCLC

The primary objective of this study is to evaluate the **pharmacokinetics**, efficacy, safety, and immunogenicity of MB12, a proposed pembrolizumab biosimilar, in comparison to Keytruda® in patients with advanced/metastatic non-squamous non-small cell lung cancer (NSCLC). This is clinically relevant as it aims to determine whether MB12 can provide a comparable therapeutic effect and safety profile to the established treatment, potentially offering an alternative option for patients with this condition.

The clinical trial involves a total of **480 participants** diagnosed with **advanced/metastatic non-squamous non-small cell lung cancer (NSCLC)**. The study population includes both male and female subjects, with an age range that spans from adults to the elderly. Participants were selected without targeting any vulnerable populations. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The sponsor has not provided detailed information regarding the main objective of the trial or specific inclusion criteria. The selection process aimed to encompass a broad demographic to ensure comprehensive data collection across different age groups and genders.

The clinical trial is designed to evaluate the **pharmacokinetics**, efficacy, safety, and immunogenicity of MB12, a proposed pembrolizumab biosimilar, compared to Keytruda® in patients with advanced/metastatic non-squamous non-small cell lung cancer (NSCLC). The study employs a randomized, double-blind, controlled trial design to ensure unbiased results and reliable data. The trial is expected to commence recruitment on January 13, 2025, and conclude by March 31, 2027, encompassing a comprehensive duration to assess long-term outcomes.

Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful enrollment, participants will attend regular follow-up visits to monitor treatment response, adverse events, and overall health status. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The end-of-study visit will mark the completion of the participant's involvement, where final assessments will be conducted to evaluate the overall impact of the treatment.

The expected length of participant involvement will span the entire trial duration, subject to individual response and adherence to the study protocol. Conditions that may lead to early termination from the study include significant adverse reactions, non-compliance with study procedures, or withdrawal of consent by the participant. The trial is conducted in accordance with ethical standards 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 clinical trial, 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. Consequently, the trial documentation lacks comprehensive information on the treatment protocols and participant management strategies.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized under phase 5, indicating a focus on post-marketing surveillance and long-term effects. The estimated recruitment start date is January 13, 2025, with an anticipated end date of March 31, 2027. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, the trial will likely involve systematic data collection and analysis to evaluate the treatment's effectiveness. The methods and schedule for measuring efficacy will be aligned with standard clinical trial practices, ensuring rigorous assessment throughout the trial duration.