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, of any gender
• People who have been diagnosed with advanced non-small cell lung cancer (either spread to other parts of the body, or at an earlier stage where surgery or other intensive treatments are not suitable)
• People whose lung cancer has been confirmed through a tissue or cell sample, or — if there is not enough tissue available — through a blood test that detects cancer DNA
• People whose cancer has a specific gene change called an EGFR mutation (most types are allowed, but a specific type called an Exon 20 insertion is not; some unusual mutation types may need extra approval from the trial organisers) (confirm with trial site)
• People whose general health and ability to function falls within an acceptable range as rated by their doctor, and who could potentially receive a second round of chemotherapy if needed
• People with an expected life expectancy of at least 12 weeks
• Women who could become pregnant must use highly effective contraception and have a negative pregnancy test before starting the trial; women who cannot become pregnant must have documented proof, such as being post-menopausal or having had a surgical procedure such as removal of the uterus, both ovaries, or both fallopian tubes (tubal ligation does not count)
• Men must be willing to use barrier contraception (such as condoms) during the trial
• People who have at least one tumour that can be measured by CT or MRI scan
• People joining after their cancer progressed on a first treatment must have complete background health information available, including details about their osimertinib treatment history
• People joining at the point of a third-line osimertinib rechallenge must have complete background health information available, must have previously received osimertinib as their first treatment followed by a specific chemotherapy combination (platinum plus pemetrexed) as their second treatment, must have received at least one dose of that chemotherapy, and at least 90 days must have passed since their last dose of first-line osimertinib

Who may not be able to join:

• People who are involved in planning or running this trial
• People who have had another serious cancer (other than certain minor skin cancers) in the past three years that could be confused with the lung cancer being studied
• People with another serious uncontrolled medical or psychiatric condition that could interfere with taking part in the trial
• People who are pregnant or breastfeeding
• People who have recently taken part in another clinical trial involving an experimental drug (within a timeframe depending on the drug used — confirm with trial site)
• People currently taking, or unable to stop taking before the trial starts, certain medications or herbal supplements that strongly affect how the body processes drugs (known as potent CYP3A4 inducers) — at least three weeks before starting would be required
• People who still have unresolved side effects from previous cancer treatment that are more than mild, with the exception of hair loss and certain nerve-related side effects from platinum chemotherapy
• People with serious uncontrolled conditions such as uncontrolled high blood pressure, active uncontrolled bleeding, or active infections including hepatitis B, hepatitis C, or HIV
• People with pressure on the spinal cord, or brain metastases that are causing symptoms and are unstable, unless they have completed treatment for those brain metastases, have been neurologically stable for at least two weeks, and if using steroids, have been on a stable dose for at least two weeks before starting the trial
• People who have persistent nausea and vomiting, long-term gut conditions, difficulty swallowing tablets, or who have had major bowel surgery that could prevent the study drug from being properly absorbed
• People with a history of a lung condition called interstitial lung disease, or lung inflammation caused by drugs or radiation that required steroid treatment
• People whose blood test results show that bone marrow, liver, or kidney function does not meet the required levels (confirm specific values with trial site)
• People with a known allergy to osimertinib or similar medicines
• People who, in their doctor's judgement, are unlikely to follow the trial requirements
• People who received chemotherapy as a preventive (adjuvant) treatment within the six months before enrolling
• People who received certain immunotherapy drugs (anti-PD-1 or anti-PD-L1) as a preventive treatment within 90 days before enrolling
• People joining before starting first-line treatment who have already had any systemic (whole-body) treatment for their EGFR-mutated advanced lung cancer
• People with certain heart-related concerns, including an abnormal heart rhythm measurement on an ECG, specific heart conduction problems, a personal or close family history of a heart condition called long QT syndrome, or who are taking medications known to affect heart rhythm (confirm details with trial site)
• People joining after progression on first-line osimertinib who have received any treatment other than osimertinib for their advanced lung cancer
• People joining at the third-line rechallenge stage who have received any treatments other than the specific sequence of osimertinib followed by platinum plus pemetrexed chemotherapy

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