Phase 1 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 aged 18 or older who have signed and dated a consent form before any study procedures begin.
• People with a confirmed diagnosis of non-small cell lung cancer (NSCLC) — either squamous or non-squamous type.
• People whose NSCLC has spread to other parts of the body or is locally advanced, and for whom curative surgery or curative radiation is not an option.
• People whose cancer has a specific genetic change called a KRAS G12C mutation, confirmed by tumor tissue testing.
• People whose cancer does not have certain other genetic changes (such as EGFR, ALK, RET, ROS1, or similar) that would make them eligible for other targeted treatments approved by the FDA.
• People whose cancer got worse after receiving an immunotherapy treatment (anti-PD-(L)1), with or without platinum-based chemotherapy.
• People who are well enough to carry out light activity and look after themselves, as measured by a standard scoring system called ECOG (score of 0 or 1).
• People who have at least one measurable area of cancer that can be tracked on scans, according to standard measurement guidelines (RECIST v1.1).
• People whose blood test results at the start of the study meet specific minimum levels for blood cells, liver function, kidney function, and other markers (confirm specific values with the trial site).
• People who are able to swallow and keep down tablets or capsules taken by mouth.
• People who could become pregnant must have a negative blood pregnancy test before joining the study.
• People who could become pregnant or people assigned male at birth with partners who could become pregnant must use two forms of contraception (including one barrier method) throughout the study and for three months after the last dose; people assigned male at birth must also avoid donating sperm during the study and for 12 months after the last dose.

Who may not be able to join:

• People who have had a blood cancer (other than stable chronic lymphocytic leukaemia) within the past year.
• People who have had another type of cancer within the past year, unless it was a very early-stage or non-invasive cancer such as cervical carcinoma in situ, ductal carcinoma in situ, certain early prostate or bladder conditions, or stage I non-melanoma skin cancer that was completely cured.
• People with a known serious allergy to the study drugs (ladarixin or sotorasib) or their ingredients.
• People who have had a severe autoimmune disease in the past six months, or who need ongoing high-dose steroid medication to manage an autoimmune condition.
• People who have cancer that has spread to the brain or spine, unless it was treated and there has been no sign of growth or bleeding for at least seven days before starting the study drugs, and no steroids have been needed for at least seven days (confirm details with trial site).
• People who have had inflammation around the heart (pericarditis) or significant fluid around the heart in the past six months.
• People with a history of certain serious lung conditions, including interstitial lung disease, radiation-related lung inflammation that required steroids, pulmonary fibrosis, or drug-induced lung inflammation.
• People with an active infection that needs antibiotic or other systemic treatment at the time of starting the study (a waiting period of at least seven days after finishing antibiotics is required).
• People who have ever tested positive for HIV.
• People with active hepatitis B or hepatitis C infection (people with well-controlled hepatitis B or C may be considered — confirm with trial site).
• People with serious uncontrolled medical conditions, including uncontrolled non-cancer illnesses, severe liver disease, or significant problems with the digestive system that could affect swallowing or absorbing medication.
• People who have had a heart attack, unstable chest pain, heart bypass surgery, or stroke in the past six months.
• People with significant heart problems, including serious irregular heartbeats, a weakened heart pumping function (ejection fraction below 50%), a resting heart rate below 50 beats per minute, or moderate-to-severe heart failure.
• People with an abnormal heart rhythm reading on an ECG (QTcF interval above 470 milliseconds).
• People with a history of significant eye inflammation, certain retinal conditions, or risk factors for retinal vein blockage in the past six months.
• People who still have unresolved side effects from a previous treatment that are worse than mild (above Grade 1), except for hair loss or certain nerve-related side effects (confirm with trial site).
• People with muscle diseases associated with elevated levels of a muscle enzyme called creatine kinase (such as muscular dystrophy or ALS).
• People who have had a blocked bile duct in the past six months, unless a bile stent is in place and working.
• People who are pregnant or breastfeeding.
• People who have received or will receive a live vaccine within 30 days before starting the study (non-live flu vaccines are permitted).
• People with known psychiatric conditions or substance use disorders that would interfere with taking part in the study.
• People who currently use or have recently used (within the past year) illicit drugs or have a history of alcohol or substance misuse.
• People with known or suspected allergies to non-steroidal anti-inflammatory drugs (NSAIDs), or to certain ingredients such as lactose, or people with certain inherited conditions affecting how the body processes sugars (such as congenital lactase deficiency or glucose-galactose intolerance).
• People who have previously been treated with a KRAS inhibitor.
• People who have previously had a bone marrow or solid organ transplant from a donor.
• People who have recently received other cancer treatments — specific waiting periods apply depending on the type of treatment (confirm exact timeframes with trial site).
• People who have had radiation therapy within seven days before starting the study drug.
• People currently taking certain medications that strongly affect a liver enzyme called CYP3A4, or certain other specific medications including phenytoin, warfarin, or high-dose amitriptyline (confirm full medication list with trial site).
• People taking herbal supplements known to affect CYP3A4, including St. John's wort, cannabis, kava, ginkgo biloba, ginseng, and others (confirm full list with trial site).
• People who have had major surgery or significant physical trauma within the past 28 days, or who are likely to need surgery during the study.
• People who have recently started certain blood-stimulating medications (such as erythropoietin or G-CSF) within two weeks before starting the study.
• People who have had a blood transfusion within one week before the first study dose.
• People who have taken medications known to cause a specific type of heart rhythm problem (Torsades de Pointes) within two weeks before starting the study.
• People who have used stomach acid-reducing medications (such as antacids, H2 blockers, or proton pump inhibitors) within three days or five half-lives before starting the study drug (whichever is longer).

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