Phase 3 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 who are willing to take part voluntarily and are able to follow the study procedures as outlined in the protocol
• People aged 18 or older, of any gender, who are in reasonably good physical condition (able to carry out light activity) and are expected to live for at least 3 months
• People who have been confirmed by a pathologist to have locally advanced, inoperable, and/or metastatic non-small cell lung cancer (a specific advanced stage)
• People who can provide a suitable tumour tissue sample (from surgery or a biopsy taken within the past 2 years) that confirms a specific genetic change called KRAS G12C mutation, as tested by a central laboratory
• People whose cancer got worse during, or who could not tolerate, a previous first-line treatment combining an immunotherapy (anti-PD-1/PD-L1) and platinum-based chemotherapy — or who had a clear medical reason for not being able to receive those treatments
• People who have at least one measurable area of cancer that can be tracked during the study
• People whose major organs (such as liver, kidneys, and bone marrow) are functioning well enough to meet the study's requirements
• Women of childbearing age who agree to use contraception during the study and for 6 months after it ends, who test negative for pregnancy within 7 days before joining, and who are not currently breastfeeding; men who agree to use contraception during the study and for 6 months after it ends

Who may not be able to join:

• People who have previously been treated with a KRAS G12C inhibitor or a chemotherapy drug called docetaxel
• People whose non-small cell lung cancer has other specific genetic driver mutations (separate from KRAS G12C)
• People who have brain or spinal fluid involvement from their cancer that is causing active symptoms or getting worse (those with a history of stable, treated brain spread may still be considered — confirm with trial site)
• People with a previous history of epilepsy, or who currently have a condition where a large vein near the heart is blocked (superior vena cava syndrome)
• People with certain heart conditions, including: moderate-to-severe heart failure; serious irregular heartbeat requiring medication; a heart attack, severe chest pain, or heart bypass surgery within the past 6 months; reduced heart pumping function below a certain level; an abnormal heart rhythm measurement (QT interval); or high blood pressure that is not well controlled
• People who have had a stroke or other serious brain blood vessel event within the past 6 months
• People who have had a serious blood clot (such as deep vein thrombosis) within the past 3 months
• People with a history of certain lung conditions such as interstitial lung disease, radiation-related lung damage, or immune-related lung inflammation previously treated with steroids — or who currently have active non-infectious lung inflammation, active tuberculosis, dust-related lung disease, significant other lung disease, or severely reduced lung function
• People at risk of serious bone damage due to cancer spread to the bones
• People with a serious active infection (of a certain severity level) or an unexplained fever above 38.5°C
• People with fluid build-up in body cavities (such as around the lungs, abdomen, or heart) that is not well controlled or that requires drainage procedures
• People with known significant problems affecting the digestive system that could interfere with absorbing oral medications, or who have had major surgery on the oesophagus or stomach/intestines that might affect drug absorption, or who are unable to swallow the study medication
• People whose side effects from previous cancer treatments have not recovered sufficiently (most side effects must have reduced to a mild level, except for hair loss or minor lab changes; nerve-related side effects must have reduced to a moderate level)
• People who are HIV positive, have liver cirrhosis, or have active viral hepatitis
• People with active syphilis
• People who require dialysis (haemodialysis or peritoneal dialysis) due to kidney failure
• People with poorly controlled diabetes (fasting blood sugar above 10 mmol/L)
• People who have previously had an organ transplant or are planning to have one
• People who weigh less than 40 kg, have a BMI below 18.5 kg/m², or have lost more than 5% of their body weight in the 3 months before joining
• People who have had major surgery or a significant injury within 4 weeks before the first dose of the study treatment
• People who have received palliative radiotherapy to a local area within 2 weeks before the first dose
• People who are pregnant or breastfeeding
• People who have another separate primary cancer at the same time
• People with serious mental illness, a history of substance misuse, or serious alcohol misuse
• People with a known allergy to the study drug or any of its ingredients
• People with any other significant medical condition or abnormality that the study doctor considers a safety risk or that could interfere with the study

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