Evaluation of Sotorasib (AMG 510) in Patients with Advanced Solid Tumors Harboring KRAS p.G12C Mutation: A Master Protocol Study

The primary objective of this study is to evaluate the efficacy and safety of **Sotorasib (AMG 510)** in subjects with **advanced solid tumors** harboring the **KRAS p.G12C mutation**. This mutation is a significant driver in various malignancies, and targeting it could provide a therapeutic benefit for patients with limited treatment options. The study aims to assess the potential of Sotorasib to improve clinical outcomes in this patient population.

The clinical trial involves a total of **970 participants** diagnosed with **Advanced Solid Tumors** harboring the **Kirsten Rat Sarcoma (KRAS) pG12C Mutation**. The study population includes both male and female subjects, with an age range spanning from 18 to 64 years. Participants were selected without targeting any vulnerable populations. The trial does not specify any particular lifestyle considerations such as diet or physical activity. The sponsor has not provided detailed information regarding the main objective or specific inclusion criteria for the study.

The clinical trial is designed to evaluate the efficacy and safety of **sotorasib** in subjects with **advanced solid tumors** harboring the **KRAS p.G12C mutation**. This is a Phase 3, randomized, double-blind, controlled trial. The estimated recruitment start date was April 26, 2022, with an anticipated end date of March 13, 2028. The trial involves multiple study visits, beginning with an inclusion visit where participants are screened for eligibility based on predefined criteria. This visit ensures that only suitable candidates are enrolled in the study.

Following the inclusion visit, participants will undergo a series of follow-up visits at regular intervals. These visits are crucial for monitoring the participants' health, assessing the drug's efficacy, and recording any adverse events. The follow-up visits will include various assessments such as physical examinations, laboratory tests, and imaging studies, as necessary. The end-of-study visit marks the conclusion of the participant's involvement in the trial, where final evaluations 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 may vary depending on individual response to treatment and overall health status. Participants may be subject to early termination from the study if they experience significant adverse effects, fail to comply with study procedures, or if the study is discontinued for any reason. The trial's design and procedures are structured to ensure the collection of high-quality data while prioritizing participant safety and well-being throughout the study duration.

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 addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. 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.

Due to the lack of specific information in the source data, further details about the **experimental medication** and any **non-experimental treatments** cannot be provided. The trial documentation should be consulted for comprehensive information regarding the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy 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 April 26, 2022, with an estimated completion date of March 13, 2028. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, Phase 3 trials typically involve comprehensive assessments to determine the therapeutic benefit of the intervention. These assessments may include various clinical measures, laboratory tests, and patient-reported outcomes, conducted at predetermined intervals throughout the study duration. The data collected will be analyzed to evaluate the intervention's impact on the targeted medical condition, ensuring a rigorous and objective assessment of efficacy.