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:

To be considered at the start of the trial:

• Adults aged 18 or older
• People who have been diagnosed with metastatic non-small cell lung cancer, confirmed by a biopsy at the enrolling hospital
• People whose tumor has a specific gene change (mutation) in a gene called EGFR, found through a tumor biopsy, fluid sample, or blood test
• People who have not yet started treatment with a targeted therapy called an EGFR TKI, or who started a specific drug called osimertinib within the past 3 weeks, and who have not had chemotherapy for their metastatic cancer (prior treatment given after surgery more than 6 months before the study started may still be acceptable)
• People who have at least one measurable area of cancer that has not been treated with radiation, as determined by the treating doctor
• People who are considered reasonably functional, scoring at least 70% on a standard health and activity scale used by doctors (called the Karnofsky Performance Status)
• People who are able to swallow tablets or capsules
• People whose blood test results show their organs are working well enough — including adequate levels of red blood cells, platelets, white blood cells, and healthy liver and kidney function (confirm specific values with the trial site)
• People who are able and willing to use highly effective birth control during the study and for a period after finishing the study drug, if there is any possibility of pregnancy — including specific requirements for both female and male participants (confirm details with trial site)
• Female participants must have a negative pregnancy test and must not be breastfeeding before starting the study drug
• Female participants who cannot become pregnant — for example, those who are post-menopausal or who have had certain surgical procedures — may meet this requirement without needing contraception (confirm specific criteria with trial site)

To be considered for the second stage of the trial (randomization):

• People who still have detectable EGFR gene changes in their blood at a specific early point in the study (around the start of the second treatment cycle)
• People who still score at least 70% on the doctors' activity and health scale at that point
• People whose blood test results still show adequate organ function at that stage (confirm specific values with trial site)
• People whose cancer has at least stayed stable (not grown) based on scan assessments before the next phase of treatment begins

Who may not be able to join:

• People who are pregnant or currently breastfeeding
• People who have had radiation therapy within 1 week before starting the study treatment (this applies to people who have not yet started osimertinib)
• People who have had major surgery within 2 weeks before starting the study treatment (this applies to people who have not yet started osimertinib)
• People who have signs of a significant lung condition called interstitial lung disease, or a history of it — including lung inflammation caused by radiation or medication that required steroid treatment
• People who have taken part in another clinical trial and received an experimental drug recently (within a timeframe based on how long that drug stays in the body, or within 3 months — whichever is longer)
• People who are currently taking, or cannot stop taking, certain medications or herbal supplements that are known to strongly interfere with how the study drug is processed in the body (confirm specific substances with trial site)
• People who still have side effects from a previous treatment that have not resolved to a mild level, with some exceptions such as hair loss or certain nerve-related side effects from prior platinum chemotherapy
• People with serious uncontrolled health conditions, such as very high blood pressure or active uncontrolled bleeding, that the doctor believes make participation unsafe
• People with an active infection, including active hepatitis B, hepatitis C, or HIV
• People with ongoing nausea and vomiting that cannot be controlled, serious ongoing digestive conditions, or those who cannot swallow tablets, or who have had major bowel surgery that could affect how the body absorbs the medication
• People with certain heart-related concerns, including an abnormal heart rhythm measurement on an ECG (specifically a QTc interval above 470 milliseconds), significant abnormalities in heart rhythm or electrical conduction, or risk factors such as heart failure, low levels of certain minerals in the blood (potassium, magnesium, or calcium), a personal or close family history of a heart condition called long QT syndrome, or use of medications known to affect heart rhythm (confirm with trial site if unsure about specific medications)
• People who have had a serious allergic reaction to osimertinib or to drugs with a similar chemical structure
• People who the doctor believes are unlikely to be able to follow the study's requirements and procedures

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