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 aged 18 or older who are willing and able to sign a consent form before any study procedures begin.
• People with a general health status that allows them to carry out normal daily activities with little or no limitation (confirm with trial site — this refers to an ECOG performance score of 0 or 1).
• People with a life expectancy of at least 3 months at the time of joining the trial.
• People who are able to provide a blood (plasma) sample at the start of the trial.
• People who have been newly diagnosed with a specific type of lung cancer — non-squamous non-small cell lung cancer (NSCLC) that has not spread from an earlier treated cancer — confirmed by tissue or cell testing to carry certain EGFR gene changes (either Exon 19 deletion or L858R mutation), and classified as an advanced or returned stage of the disease that cannot be cured by surgery or radiotherapy.
• People whose EGFR gene mutation (Exon 19 deletion or L858R) can be detected in a blood sample through a specific central laboratory test at the time of screening.
• People who have not yet received treatment for advanced lung cancer and who plan to receive osimertinib plus chemotherapy as their first treatment. People who previously received adjuvant or neo-adjuvant therapy (such as chemotherapy, radiotherapy, immunotherapy, or other treatments) may still be eligible, as long as that treatment was completed at least 12 months before starting this trial.
• People who have cancer that has spread to the brain or surrounding areas (CNS metastases), provided those areas have been stable and without symptoms for at least 2 weeks (or at least 2 weeks of stable neurological status after completing any treatment for those areas).
• People who have at least one measurable tumour area that has not previously been treated with radiation, is large enough to be measured accurately on a scan, and is suitable for repeated measurement during the trial.
• People with hepatitis B virus (HBV) infection may be eligible if they meet all of the following: no hepatitis C (HCV) co-infection or history of it; no HIV infection; and specific conditions relating to their HBV treatment and blood test results are met (confirm with trial site for full details).
• People living with HIV may be eligible if they meet all of the following: no HBV or HCV co-infection; undetectable viral levels for at least 6 months; a specific immune cell count above a certain threshold; no serious HIV-related infections in the past 12 months; and stable on the same HIV medications for at least 4 weeks (confirm with trial site for full details).
• Women who could become pregnant must have a negative pregnancy test before starting and must use highly effective contraception. Women who cannot become pregnant — due to being post-menopausal or having had certain surgical procedures — are also eligible (confirm with trial site for specific definitions).
• Men must be willing to use barrier contraception (such as condoms) during the trial.

Who may not be able to join:

• People with a history of a lung condition called interstitial lung disease (ILD), lung inflammation caused by radiation that required steroid treatment, or any signs of currently active ILD.
• People with severe or uncontrolled health conditions — such as uncontrolled high blood pressure, active uncontrolled bleeding, or active infections (including active hepatitis C, uncontrolled HIV, or uncontrolled hepatitis B) — that in the investigator's opinion make participation unsafe or difficult.
• People with certain heart-related issues, including an abnormal heart rhythm reading on an ECG, specific electrical conduction problems in the heart, or risk factors for dangerous heart rhythm problems — such as low levels of magnesium, calcium, or potassium in the blood; a condition called long QT syndrome; a family history of long QT syndrome; an unexplained sudden death of a close relative under 40 years of age; or use of medications known to cause heart rhythm problems (confirm with trial site for full details).
• People whose blood test results show that the bone marrow, liver, or kidneys are not functioning well enough — for example, low red or white blood cell counts, low platelets, or abnormal liver or kidney values (confirm with trial site for specific thresholds).
• People who have had another active cancer that required treatment within the past 2 years.
• People who still have significant side effects from a previous cancer treatment (above a mild level), with the exception of hair loss or certain nerve-related side effects from prior platinum chemotherapy.
• People who have ongoing severe nausea or vomiting, a long-term digestive condition, an inability to swallow tablets, or who have had a significant portion of their bowel removed, which could prevent the study medication from being properly absorbed.
• People who have previously received systemic treatment (such as chemotherapy, immunotherapy, or targeted therapy) for advanced lung cancer that could not be cured by surgery or radiation. Previous adjuvant or neo-adjuvant treatments are permitted, provided they were completed at least 12 months before any cancer recurrence.
• People who have previously been treated with an EGFR-targeted therapy (a type of drug called an EGFR tyrosine kinase inhibitor, or EGFR-TKI).
• People who have had major surgery within 4 weeks before the first dose of study treatment. Minor procedures such as placement of a vascular line or certain biopsy procedures are permitted.
• People who have received radiation therapy covering more than 30% of the bone marrow, or wide-field radiation, within 4 weeks before the first dose of study treatment.
• People who are currently taking, or cannot stop taking before the trial starts, certain medications or herbal supplements that are known to strongly affect how the body processes the study drug (specifically strong inducers of an enzyme called CYP3A4) — these must be stopped at least 3 weeks before starting the trial.
• People who have taken part in another clinical trial with an experimental treatment within the past 3 months, or within 5 half-lives of that experimental compound (whichever is longer).
• People who have had a severe allergic reaction to osimertinib or to drugs with a similar chemical structure, or to any of the inactive ingredients in the medication.
• People for whom the chemotherapy drugs used in this trial (pemetrexed and cisplatin or carboplatin) are medically not suitable according to approved local guidelines.
• Women who are currently breastfeeding.
• People who are directly involved in planning or running this study.
• People who, in the investigator's judgement, are unlikely to follow the trial's procedures and requirements.

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