Phase 2 Lung Cancer Trial, Recruiting

Written by an AI model from 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 who have signed a written consent form agreeing to take part in the study
• People who have been confirmed through a biopsy to have non-small cell lung cancer that has spread to other parts of the body or has come back after previous treatment
• People whose cancer has a specific genetic change called a KRAS G12C mutation, found through a tumour biopsy or a blood test
• People who have not yet received any treatment for their advanced cancer
• People whose cancer can be measured on scans according to a standard set of rules (called RECIST 1.1)
• People who are reasonably well and able to carry out most daily activities (as measured by a Karnofsky Performance Status score of 70% or higher)
• People aged 18 or older
• People whose blood counts and organ function (including liver, kidneys, and bone marrow) meet the required levels as tested by blood tests
• People who are willing to have two tumour biopsies — one before treatment starts and one between 7 and 21 days after starting treatment
• People who have either chosen not to have standard first-line chemotherapy and/or immunotherapy, or whose cancer came back after receiving chemotherapy or immunotherapy for early-stage lung cancer (stage I–III)
• Women who are not able to become pregnant (for example, after menopause, or after certain surgeries), or who agree to use effective contraception throughout the study and for at least 6 months after the last dose of study medication (confirm with trial site for full details)
• Women of childbearing potential who have a negative pregnancy blood test before starting the study
• Men who are sexually active with a woman who could become pregnant must agree to use a condom with spermicide, and their partner must also use an effective form of contraception; men must also not donate sperm during the study or for at least 7 days after the last dose of study medication

Who may not be able to join:

• People who have brain metastases that are causing symptoms
• People who have had radiation therapy within 1 week before starting the study treatment
• People who have had major surgery within 1 week before starting the study treatment
• People who received certain immunotherapy (anti-PD-1 or PD-L1) for early-stage lung cancer within 12 weeks before starting the study drug (sotorasib)
• People who still have unresolved side effects (above a mild level) from any previous cancer treatment
• People who have had inflammation of the lungs (pneumonitis) above a mild level from any previous treatment
• People with moderate to severe heart failure, or who were hospitalised for heart failure within the past 6 months
• People with serious gut or digestive conditions that prevent them from swallowing or absorbing oral medication (for example, Crohn's disease or ulcerative colitis that is not controlled)
• People who currently test positive for hepatitis B surface antigen (with some exceptions — confirm with trial site)
• People who currently test positive for hepatitis C antibodies (with some exceptions for those who have completed treatment — confirm with trial site)
• People with other active or ongoing liver disease
• People currently taking part in another clinical trial, or who finished another clinical trial less than 28 days ago
• People taking certain medications that may interact with the study drug, unless reviewed and approved by the lead doctor (confirm with trial site for specific medication types)
• People who do not agree to the required tumour biopsies at the time of signing the consent form

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