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 read and understood the trial information and are willing to sign a consent form
• People aged 18 or older, of any gender
• People who have been confirmed by tissue or cell testing to have non-small cell lung cancer (NSCLC) that is either locally advanced (at a stage where surgery or radiotherapy is not suitable) or has spread to other parts of the body
• People whose test results confirm a specific genetic change in their tumour called an EGFR exon 20 insertion mutation
• People in Group 1: those whose NSCLC has stopped responding to, or who could not tolerate, at least one chemotherapy regimen (including at least one platinum-based treatment), and who have not previously received a third-generation EGFR-targeting drug; OR people in Group 2: those who meet the same chemotherapy history AND whose cancer progressed while taking a standard dose of a third-generation EGFR-targeting drug (such as osimertinib 80mg daily, or similar)
• People whose general physical health and ability to carry out daily activities falls within an acceptable range on a standard scale (ECOG score 0–2), with no decline in the past two weeks, and who are expected to survive for at least 12 weeks
• People who have at least one tumour that can be measured using standard imaging criteria
• People whose blood test results show that their bone marrow, liver, kidney, and blood clotting function are all within the levels required by the trial
• Women who could become pregnant must have a negative pregnancy blood test before starting treatment and must use adequate contraception (such as condoms), and must not be breastfeeding
• Male participants must be willing to use barrier contraception (condoms) throughout the study

Who may not be able to join:

• People who have had another cancer in the past 5 years, with the exception of certain skin cancers, bladder cancer in situ, or cervical cancer in situ that have been fully treated and cured
• People who have previously been treated with drugs specifically targeting the EGFR exon 20 insertion mutation (such as Poziotinib, TAK788, or others listed), or who have taken certain EGFR-targeting drugs at higher-than-standard doses
• People who have received any other cancer treatment within the 4 weeks before starting this trial (or within 6 weeks for certain chemotherapy types, or within 2 weeks or 5 half-lives for certain targeted drugs — whichever is longer)
• People who have taken part in another clinical trial and received treatment within the 4 weeks before starting this trial
• People who have had major surgery within the 4 weeks before starting this trial (not including minor procedures to place a drip or port)
• People who are currently taking, or have taken within the past week, certain strong medications or herbal supplements that affect how the body processes drugs (specifically strong CYP3A4 or CYP2C8 inhibitors or inducers)
• People who still have significant side effects from previous treatments (above a mild level), except for hair loss, or mild nerve-related side effects from prior platinum chemotherapy
• People who have cancer that has spread to the spinal cord or the lining of the brain, or brain metastases — unless those brain metastases are stable, causing no symptoms, and have not required steroid treatment in the 4 weeks before the trial
• People with significant fluid build-up around the lungs or in the abdomen that is causing symptoms and is not stable
• People with serious or uncontrolled health conditions such as uncontrolled high blood pressure, diabetes, severe heart failure, unstable chest pain, a heart attack within the past year, or active bleeding
• People with an active infection that is not under control
• People with active Hepatitis B or active Hepatitis C infections (people with Hepatitis B may be eligible if their viral levels are brought down to within normal range with antiviral treatment before and during the trial — confirm with trial site)
• People with HIV, other immune system conditions, or a history of organ transplant
• People whose heart's electrical activity shows a prolonged QTc interval (above 450 milliseconds on average across multiple ECG readings)
• People with significant heart rhythm or electrical conduction problems detected on a resting ECG
• People with conditions that increase the risk of heart rhythm problems, such as heart failure, low potassium levels (unless corrected before starting), a personal or family history of a condition called long QT syndrome, or a family history of unexplained sudden death before age 40
• People with a history of a lung condition called interstitial lung disease, or lung inflammation from radiation that required steroid treatment, or any signs of active interstitial lung disease
• People who have persistent nausea and vomiting, a chronic digestive condition, difficulty swallowing tablets, or who have had a large portion of their bowel removed, which could affect how the study drug is absorbed
• People with a known allergy to any ingredient in the study drug (BEBT-109)
• Women who are currently breastfeeding
• People who the trial doctor determines are unsuitable for any clinical or other reason

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