A Study of KRA-533 in Advanced KRASG12C-Mutated Non-Small Cell Lung Cancer Patients with Prior Therapy Progression or Immuno/Chemotherapy Contraindications

The primary objective of the K-SAB trial is to evaluate the efficacy of a novel therapeutic intervention in subjects with **advanced KRASG12C-mutated non-small cell lung cancer** who have previously progressed on at least one prior line of therapy or have contraindications for immuno/chemotherapy. This study is clinically relevant as it addresses a significant unmet need in this patient population, offering potential therapeutic options for those with limited treatment alternatives.

The clinical trial involves participants diagnosed with **advanced KRASG12C-mutated non-small cell lung cancer** who have previously progressed on at least one prior line of therapy or have contraindications for immuno/chemotherapy. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, indicating adult and older adult participants. The trial includes a vulnerable population, although specific details regarding the total number of participants have not been provided by the sponsor. Participants were selected based on their medical condition and previous treatment history. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the efficacy and safety of an investigational treatment in subjects with **advanced KRASG12C-mutated non-small cell lung cancer** who have previously progressed on at least one prior line of therapy or have contraindications for immuno/chemotherapy. This is a Phase 3, randomized, double-blind, controlled trial. The estimated recruitment start date is April 1, 2023, with an anticipated end date of April 1, 2025, making the overall trial duration approximately two years.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive either the investigational treatment or a control. The trial will include multiple follow-up visits to monitor the participants' response to the treatment and any adverse events. These visits will occur at regular intervals throughout the study period. The end-of-study visit will be conducted to perform final assessments and gather comprehensive data on the treatment's long-term effects.

The expected length of participant involvement in the trial is contingent upon the individual's response to the treatment and the occurrence of any adverse events. Participants may be subject to early termination from the study if they experience significant adverse reactions, fail to comply with the study protocol, or withdraw consent. The trial's design ensures that all procedures are conducted in accordance with ethical standards and regulatory requirements, prioritizing participant safety and data integrity.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is available from the provided data. Consequently, a detailed description of the experimental treatment cannot be provided.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Therefore, a description of these elements is not possible based on the current data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. As such, these aspects cannot be detailed in this description.

The clinical trial is designed to assess efficacy within a Phase 3 framework. The trial is scheduled to commence recruitment on April 1, 2023, with an estimated completion date of April 1, 2025. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The trial will follow a structured methodology for measuring, collecting, and analyzing these efficacy parameters, consistent with the standards of Phase 3 trials. The trial's design and execution will adhere to rigorous scientific and ethical standards to ensure the reliability and validity of the efficacy assessments.