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 are older than 18 years of age
• People whose overall health and ability to carry out daily activities meets a certain level of functioning (confirm with trial site what this means for a specific situation)
• People who have been diagnosed with a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread or cannot be surgically removed, and whose cancer has a specific gene change called KRAS G12C, confirmed by a lab test on either a tissue sample or a blood sample
• People whose cancer has come back or gotten worse after receiving at least one previous treatment for advanced or metastatic disease
• People who, in the opinion of the trial doctor, are expected to live for more than 3 months from the time of screening
• People who have areas of cancer that can be safely biopsied, and who are willing to have tissue samples taken before, during, and after treatment
• People whose blood tests show that the bone marrow, liver, kidneys, and other organs are working well enough, based on tests done within 14 days before joining the trial
• People who understand, agree to, and sign the trial's consent form before any trial-related procedures begin
• People who are able and willing to attend all required trial visits and follow the trial procedures
• People who are covered by a Social Security system or an equivalent benefit scheme (this appears to be a French healthcare requirement — confirm with the trial site)

Who may not be able to join:

• People who are not willing to provide tissue or blood samples as required by the trial
• People who have recently taken certain medications that interact with a liver enzyme called CYP3A4 or a protein called P-gp (these are specific drug interaction concerns — the trial site can review any current medications)
• People who have recently taken strong medications or herbal supplements — including St. John's Wort — that affect how the body processes certain drugs through the CYP3A4 pathway, unless reviewed and approved by the lead trial doctor
• People who have not waited long enough after their last cancer treatment before joining — generally at least 14 days or a certain number of "half-lives" of the drug, whichever is longer
• People who have previously been treated with a KRAS inhibitor (a drug that specifically targets the KRAS gene mutation)
• People who have had major surgery within 28 days before joining the trial
• People who have a serious digestive condition that prevents them from absorbing food or medication properly, or who cannot swallow tablets
• People who have significant heart disease, have had a heart attack within the past 6 months, or have unstable heart rhythm or chest pain problems
• People who have had a serious infection in the 2 weeks before joining, such as a severe chest infection or a blood infection requiring hospitalisation
• People who have ongoing lung inflammation (pneumonitis) caused by a previous treatment that has not resolved
• People who have significant nerve damage (numbness, tingling, or weakness) in their hands or feet that is rated at a moderate level or above
• People who have uncontrolled fluid build-up around the lungs, heart, or abdomen that needs to be drained more than once a month (though people with a special long-term drainage tube in place may be considered with approval from the lead doctor)
• People who have a known history of HIV infection
• People who have evidence of active hepatitis B or hepatitis C infection, based on specific blood test results (the trial site will explain which tests are needed)
• People who have cancer that has spread to the lining around the brain (leptomeningeal disease) or who have active brain metastases — though people who have had brain metastases treated with surgery or radiation at least 2 weeks before joining may be considered if their symptoms are mild, they have been on a stable dose of steroid medication for at least 2 weeks if needed, and a recent brain scan shows no new or worsening areas
• People who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during treatment and for 7 days after the last dose of the study drug (sotorasib)
• Women who are able to become pregnant but are not willing to use at least one highly effective form of contraception during treatment and for 7 days after the last dose of sotorasib
• Women who are able to become pregnant and have a positive pregnancy test at the screening visit or on the first day of the trial
• Men with a female partner who could become pregnant, who are not willing to use contraception or avoid sexual intercourse during treatment and for 7 days after the last dose of sotorasib
• Men whose partner is pregnant, who are not willing to abstain from sex or use a condom during treatment and for 7 days after the last dose of sotorasib
• Men who are not willing to stop donating sperm during treatment and for 7 days after the last dose of the study drug
• People who have had another type of cancer within the past 3 years, with some exceptions such as certain treated skin cancers or other cancers that were fully cured
• People who are currently taking part in another clinical trial testing an experimental drug
• People who are under legal guardianship, have had their freedom restricted by a legal or administrative decision, or are unable to give their own informed consent
• People who have a known allergy to sotorasib or any of its ingredients
• People with certain rare inherited conditions affecting how the body handles specific sugars (galactose intolerance, lactase deficiency, or glucose-galactose malabsorption)

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