Evaluation of Safety and Anti-tumor Activity of TT125-802 with Adagrasib or Osimertinib in Advanced Non-Small Cell Lung Cancer Patients

The primary objective of this study is to evaluate the **safety** and **anti-tumor activity** of TT125-802 in combination with either **Adagrasib** or **Osimertinib** in patients with **advanced non-small cell lung cancer (NSCLC)**. This is clinically relevant as it aims to determine the potential therapeutic benefits and safety profile of these combinations in a population with limited treatment options, potentially leading to improved outcomes for patients with advanced NSCLC.

The clinical trial involves a total of **80 participants** diagnosed with **advanced non-small cell lung cancer (NSCLC)**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. Participants were selected to include a vulnerable population, although specific criteria for vulnerability are not detailed. The trial does not specify 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 the principal inclusion criteria.

The clinical trial is designed to evaluate the safety and anti-tumor activity of TT125-802 in combination with **Adagrasib** or **Osimertinib** in patients with advanced non-small cell lung cancer (**NSCLC**). This is an open-label, multicenter, Phase 1a/1b study. The trial is expected to commence recruitment on July 1, 2025, and is estimated to conclude by December 31, 2028. The study will involve a series of structured visits, beginning with an inclusion visit where participants will undergo screening to determine eligibility based on predefined criteria. Following successful inclusion, participants will be randomized to receive the investigational treatment. The trial will not employ a double-blind or placebo-controlled design, allowing both investigators and participants to be aware of the treatment being administered.

Participants will be required to attend regular follow-up visits throughout the study duration. These visits are intended to monitor the safety and efficacy of the treatment, assess any adverse events, and ensure compliance with the study protocol. The frequency and specific assessments conducted during these visits will be determined by the study protocol. The end-of-study visit will mark the completion of the participant's involvement in the trial, during which final evaluations will be conducted to gather comprehensive data on the treatment's impact.

The expected length of participant involvement will vary depending on individual response to treatment and the occurrence of any adverse events. Conditions that may lead to early termination from the study include significant adverse reactions, disease progression, or withdrawal of consent by the participant. The study aims to provide valuable insights into the potential benefits and risks associated with the investigational treatment for advanced NSCLC, contributing to the broader understanding of therapeutic options for this condition.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Additionally, there is no information on any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Details about drug administration, dosing schedules, and participant compliance monitoring are also not available. The data does not include any relevant information about the experimental or non-experimental treatments involved in the clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on July 1, 2025, with an estimated completion date of December 31, 2028. The efficacy assessment will be conducted through a series of pre-defined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis, adhering to the rigorous standards expected in a Phase 3 clinical trial. The study will focus on evaluating the efficacy of the investigational product over the course of the trial period, with results contributing to the understanding of its therapeutic potential.