Sotorasib vs. Durvalumab for KRAS G12C Mutant Locally Advanced Non-small Cell Lung Cancer with Minimal Residual Disease
This study aims to compare the effectiveness of Sotorasib and Durvalumab in treating locally advanced non-small cell lung cancer with KRAS G12C mutation and minimal residual disease, by evaluating the progression-free survival.
Durvalumab
+ Sotorasib
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Carcinoma, Non-Small-Cell Lung
Treatment Study
Summary
Study start date: March 20, 2024
Actual date on which the first participant was enrolled.This study focuses on patients with a type of lung cancer called non-small cell lung cancer that is locally advanced and has a specific mutation known as KRAS G12C. These patients are either about to start, are currently undergoing, or have just finished a combination of chemotherapy and radiation therapy. The study aims to determine whether switching to a medication called sotorasib is more effective than continuing with a treatment called durvalumab for patients who still have traces of cancer DNA in their blood after the initial treatment. This is important because finding a more effective treatment could potentially improve survival rates and outcomes for these patients. Participants in this study will first complete standard treatments as planned, which include chemotherapy and radiation therapy. If traces of cancer DNA are still detectable in their blood after these initial treatments and their cancer has not progressed, they will continue with durvalumab treatment. During this period, blood tests will measure any remaining cancer DNA. Those who still show traces of cancer DNA will be randomly assigned to either continue with durvalumab or switch to taking sotorasib pills daily. The study will monitor how long patients live without their cancer worsening to evaluate the effectiveness of each treatment. Patients switching to sotorasib will first stop durvalumab for 28 days before starting the new medication. The study aims to provide insights into which treatment option better prevents cancer from progressing.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 10 locations
University of Miami (Data Collection Only)
Miami, United StatesOpen University of Miami (Data Collection Only) in Google MapsUniversity of Michigan (Data Collection Only)
Ann Arbor, United StatesMemorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, United StatesMemorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, United States