Phase 2 Lung Cancer Trial, Recruiting

Written by an AI model from the 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 with a confirmed diagnosis of a specific type of lung cancer called non-squamous non-small cell lung cancer (NSCLC), confirmed by a central laboratory
• People whose lung cancer has been staged as Stage I (an early stage), based on a standard staging system called the 8th edition TNM classification
• People whose tumor has been tested by a central laboratory and found to have one of two specific gene changes (called EGFR mutations — Ex19del or L858R), which may or may not appear alongside other EGFR mutations including T790M
• People who have had their lung cancer completely removed by surgery (lobectomy), with no cancer cells found at the surgical edges, performed either through open surgery or keyhole surgery (VATS)
• People whose tumor tissue has been confirmed by a central laboratory to have certain features: either at least 10% of specific cell patterns (solid and/or micropapillary components) or a feature called STAS
• People who had brain imaging done before surgery or before joining the trial
• People who are able to start the study treatment (Osimertinib) within 10 weeks of their surgery
• People who are in good general physical health, rated 0 or 1 on the WHO performance scale (meaning fully active or able to carry out light activities)
• People who are able to provide tissue samples from their surgery (either paraffin-embedded sections, wax blocks, or frozen tissue)
• Women who are either confirmed to be unable to have children naturally (due to age and menopause criteria, or due to surgical procedures such as hysterectomy, removal of both ovaries, or removal of both fallopian tubes), or who have a negative pregnancy test and are using highly effective contraception for at least 2 weeks before starting the study drug and are not breastfeeding
• Male participants who are willing to use barrier contraception (such as condoms) during the trial

Who may not be able to join:

• People who have received any other cancer treatments before enrolling in the trial
• People whose surgery involved only a smaller type of lung removal called a segmental resection or wedge resection (rather than a full lobectomy)
• People with a history of another cancer, unless it was a non-melanoma skin cancer, a very early-stage cancer (carcinoma in situ), or another cancer that was successfully treated with no signs of return for at least 5 years, as determined by the treating doctor
• People with serious or poorly controlled health conditions, including uncontrolled high blood pressure, active bleeding, active infections such as hepatitis B, hepatitis C, or HIV, or any other condition the trial doctor believes would make participation unsafe
• People with certain heart problems, including:
  • A specific measurement of heart rhythm (QTc interval) above 470 milliseconds on three ECG (heart tracing) tests
  • Certain abnormal heart rhythms or conduction patterns found on a resting ECG (such as specific types of heart block)
  • Conditions or factors that raise the risk of abnormal heart rhythms, such as heart failure, low potassium levels, a hereditary heart condition called long QT syndrome, an unexplained death in a close family member under age 40, or taking medications known to affect heart rhythm
• People who have had a lung condition called interstitial lung disease, whether from a previous illness, a medication, or radiation treatment requiring steroids, or who currently have active interstitial lung disease
• People whose blood test results show that their bone marrow or organ function is not within the required range (including low white blood cell counts, low platelets, low haemoglobin, or abnormal liver or kidney function results)
• People who have had an allergic reaction to Osimertinib or to medications with a similar chemical structure
• People who have ongoing uncontrolled nausea or vomiting, a serious digestive condition, difficulty swallowing tablets, or who have had major bowel surgery that could prevent the medication from being properly absorbed
• People who have evidence of damage to the surface of the eye (corneal injury), confirmed by a specialist eye examination
• People who are currently pregnant or breastfeeding
• People who, in the trial doctor's judgement, are unlikely to be able to follow the study procedures and requirements

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