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 been confirmed by laboratory testing to have non-small cell lung cancer (NSCLC).
• People whose cancer is at an advanced stage — either stage IV, stage IIIB that cannot be treated with a combination of standard therapies, or cancer that has come back after earlier treatment for stage I–III disease.
• People whose tumour has a specific genetic change called an EGFR exon 20 insertion mutation, detected by an approved laboratory test.
• People who have measurable areas of cancer that can be tracked, with all disease sites assessed within 4 weeks before joining the trial.
• People who have already received at least one previous treatment for their advanced lung cancer (there is no upper limit on the number of prior treatments).
• People aged 18 or older.
• People who are generally well enough to carry out everyday activities with no or minimal limitations, as measured by a standard medical scale (ECOG performance status of 0 or 1).
• People whose recent blood test results (within 4 weeks before joining) show that their blood counts, liver function, and kidney function are within acceptable ranges as defined by the trial (confirm specific values with the trial site).
• People whose heart is pumping effectively, confirmed by a heart scan within 4 weeks before joining, with a pumping function (ejection fraction) at or above the normal lower limit — or at least 50% if no local lower limit is defined.
• People who have no unresolved side effects from previous treatments, except for hair loss or certain nerve-related effects from prior platinum-based chemotherapy, which are allowed up to a moderate level.

Who may not be able to join:

• People who have previously been treated with the drug osimertinib.
• People who have received treatments targeting PD-L1, PD-1, or CTLA-4 within the 6 months before joining.
• People who currently have active or symptomatic lung inflammation (interstitial lung disease or interstitial pneumonitis), or who have a significant history of these conditions or radiation-related lung inflammation.
• People who have had radiation treatment to the lung area within 4 weeks before starting treatment (specific timeframes vary depending on the type and location of radiation — confirm with the trial site).
• People who currently have brain metastases causing symptoms, disease spreading along the lining of the brain or spinal cord, or spinal cord compression. People with stable, symptom-free brain metastases who have been on a steady dose of steroids for at least 2 weeks may still be considered (confirm with trial site).
• People with certain heart conditions, including: an irregular heart electrical signal (QTc interval of 470 milliseconds or more on ECG); a history of heart rhythm problems linked to previous medications; certain abnormal heart rhythms or electrical patterns; symptomatic heart failure (moderate to severe); low levels of potassium, magnesium, or calcium in the blood; congenital long QT syndrome; or a family history of long QT syndrome or unexplained sudden death before age 40 in a close relative.
• People who are currently taking medications known to affect heart rhythm in a specific way (Torsades de Pointes risk) — confirm specific medications with the trial site.
• People who have another active cancer. People whose second cancer has been fully treated and is no longer active may still be considered.
• People currently taking part in another clinical trial or taking another experimental medicine, unless a sufficient washout period (at least two weeks or five half-lives, whichever is longer) has passed.
• People with uncontrolled ongoing illness, active infection, unstable heart conditions, or mental health or social circumstances that would make it difficult to follow the trial requirements.
• People with a known allergy or sensitivity to osimertinib or similar medicines.
• People currently taking strong CYP3A4-inducing medications or herbal supplements (including St John's Wort) who are unable to stop these at least 3 weeks before starting treatment.
• People with ongoing nausea or vomiting that cannot be managed, chronic digestive conditions, an inability to swallow tablets, or a history of significant bowel surgery that could prevent proper absorption of the study drug.
• People who are pregnant or breastfeeding. Women who could become pregnant must have a negative pregnancy test within 2 weeks before joining.
• Women who could become pregnant and sexually active men who are unwilling or unable to use effective contraception during the trial and for a specified period after the last dose (6 weeks for women; 4 months for men).

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