Phase 2 Lung Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 80 years old or younger, of any sex.
• People who are generally well enough to carry out light activity and care for themselves (a medical team would assess this using a standard fitness scale scored 0 or 1).
• People diagnosed with a specific type of lung cancer called non-small cell lung cancer (NSCLC) that cannot be removed by surgery and is classified as Stage III (covering certain sub-stages), confirmed by laboratory testing of tissue or cell samples.
• People whose lung cancer has been tested and found to carry a specific genetic change called KRAS p.G12C, detected either from a tissue sample or a blood test.
• People who have not previously received any treatment for this stage of their lung cancer.
• People whose doctors estimate they have a life expectancy of at least 12 weeks.
• People whose doctors have determined they are not suitable for the standard combined chemotherapy and radiotherapy treatment, for one or more specific medical reasons (confirm with trial site for the full list of reasons).
• People who have had a PET-CT scan confirming the cancer has not spread to distant parts of the body and cannot be surgically removed.
• People who have had a brain CT or MRI scan as part of their assessment.
• People who have at least one measurable area of cancer visible on scans, assessed using a standard measurement system called RECIST v1.1.
• People whose blood tests show their blood cell counts and organ function are at adequate levels.
• People who are willing and able to attend scheduled visits and follow the study procedures.
• Women of childbearing potential who have had a negative pregnancy test within 14 days before joining the trial.
• Women of childbearing potential who agree to use a highly effective form of contraception (not hormonal — preferably a barrier method with spermicide, an IUD, tubal occlusion, a vasectomised partner, or full abstinence) during the study and for 7 days after the last dose of the study drug (Sotorasib).
• Men with female partners of childbearing potential who agree to use a highly effective form of contraception during the study and for 7 days after the last dose of the study drug.
• Women who are not post-menopausal or surgically sterile must have a negative blood pregnancy test within 14 days before joining.
• People whose heart's electrical activity (measured by ECG) falls within specific safe ranges: a QTc interval of 470 milliseconds or less for women, and 450 milliseconds or less for men, based on the average of three ECG readings.

Who may not be able to join:

• People whose lung cancer has certain other specific genetic changes — EGFR sensitising mutations, ALK translocations, or ROS1 mutations.
• People who have lost more than 10% of their body weight in the previous 3 months.
• People experiencing uncontrolled nerve damage causing sensory symptoms rated at grade 2 or higher on a standard medical scale.
• People who have had major surgery within 28 days before the start of the study.
• People with a significant digestive condition that severely affects their ability to absorb food or medication, or who are unable to take medication by mouth.
• People with significant heart disease, including certain levels of heart failure, a heart attack within the past 6 months, unstable irregular heartbeat, or unstable chest pain.
• People with ongoing heart rhythm problems at a certain level of severity, uncontrolled irregular heart rhythm (atrial fibrillation), or a QTcF heart measurement above 470 milliseconds.
• People who have had a serious infection requiring hospitalisation within 4 weeks before joining the trial.
• People who have taken antibiotic treatment (by mouth or intravenously) within 2 weeks before joining the trial.
• People with any other ongoing, uncontrolled medical condition.
• People with a condition called vena cava syndrome, where a major vein in the body is blocked.
• People with cancer-related fluid build-up around the lungs or heart that suggests the cancer may have spread, or where fluid tested negative for cancer cells but was found to be inflammatory in nature (a small amount of fluid too small to safely test may be acceptable — confirm with trial site).
• People who have previously received any anti-cancer drug treatment.
• People who have had a different cancer (other than this lung cancer) within the 3 years before joining the trial.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
• People who test positive for HIV.
• People with active hepatitis B or hepatitis C infection.
• People with active tuberculosis.
• People with any other medical condition, abnormal test result, or finding that could make participation unsafe or affect the reliability of the study results.
• People with any illness or condition that affects their ability to understand or follow the study procedures.
• People with a known or suspected allergy to drugs with a similar chemical structure to the study drug.
• People with any other significant medical finding that would make participation inadvisable.
• People who have taken certain medications that strongly affect how the body processes drugs (strong CYP3A4 inducers) within 14 days before the study starts (confirm with trial site).
• People who have taken proton pump inhibitors (a type of medication for stomach acid) within 14 days before the study starts.

Important: Always verify eligibility with the trial site directly before applying.