Pharmacokinetic Comparison of ABP 234 and Pembrolizumab in Adjuvant Therapy for Early-stage Non-squamous Non-small Cell Lung Cancer

The primary objective of this study is to evaluate the **pharmacokinetic** similarity between ABP 234 and Keytruda® (pembrolizumab) in subjects with early-stage non-squamous non-small cell lung cancer (NSCLC) as adjuvant treatment following resection and platinum-based chemotherapy. This is clinically relevant as establishing pharmacokinetic similarity can support the use of ABP 234 as a potential therapeutic alternative to Keytruda®, potentially offering more treatment options for patients with this type of lung cancer.

The clinical trial involves a total of **71 participants** diagnosed with **early-stage non-squamous non-small cell lung cancer**. The study population includes both male and female subjects, with an age range encompassing adults and older adults. Participants were selected based on specific criteria, although the principal inclusion criteria are not provided. The trial does not focus on a vulnerable population. Lifestyle considerations such as diet, physical activity, or habits are not specified. The selection process aimed to ensure a representative sample of the general population affected by this condition, without targeting any specific lifestyle factors.

The clinical trial is designed to evaluate the **pharmacokinetic** similarity between ABP 234 and Keytruda® (pembrolizumab) in subjects with early-stage non-squamous non-small cell lung cancer as adjuvant treatment following resection and platinum-based chemotherapy. The trial is structured as a randomized, double-blind, controlled study, ensuring that neither the participants nor the investigators are aware of the treatment assignments, thereby minimizing bias. The estimated recruitment start date is June 12, 2024, with the trial expected to conclude by December 15, 2026, indicating a total duration of approximately 30 months.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This visit will involve a comprehensive evaluation, including medical history, physical examination, and laboratory tests. Following successful screening, participants will be randomized to receive either ABP 234 or Keytruda®. Subsequent follow-up visits will be scheduled at regular intervals to monitor safety, efficacy, and pharmacokinetic parameters. These visits will include clinical assessments, blood sampling, and adverse event monitoring. The end-of-study visit will occur after the final treatment cycle, where a thorough evaluation will be conducted to assess the overall outcomes and any long-term effects.

The expected length of participant involvement is approximately 24 months, depending on individual response and adherence to the study protocol. Conditions that may lead to early termination from the study include significant adverse events, withdrawal of consent, or non-compliance with study procedures. Participants will be closely monitored throughout the trial to ensure their safety and well-being, with any necessary adjustments made to the study protocol as required.

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, an orphan drug, or any other special category. 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 treatment. 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 in the provided data.

The clinical trial is set to evaluate efficacy through a structured assessment process. The trial is categorized under Phase 5, indicating a focus on post-marketing surveillance to gather additional information on the drug's effects in a larger population. The estimated recruitment start date is June 12, 2024, with an anticipated end date of December 15, 2026. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, the trial will likely involve systematic data collection and analysis to assess the treatment's impact. The methods and schedule for measuring efficacy will be aligned with standard clinical trial practices, ensuring rigorous evaluation of the treatment's effectiveness.