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 at the time of signing the consent form, regardless of gender
• People with a confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC) that is locally advanced (stage IIIB or IIIC) or has spread to other parts of the body (stage IV), and cannot be treated with surgery or radiotherapy to cure it
• People whose tumour has a specific genetic change called an EGFR mutation (specifically an exon 19 deletion and/or L858R mutation)
• People who have completed 3 to 5 weeks of first-line treatment with osimertinib alone, whose disease has not worsened during that time, and who are willing to have a blood test to look for cancer DNA (ctDNA) — results of this test will determine which group of the trial a person is placed in
• People who have at least one measurable tumour that can be tracked using standard imaging measurements
• People whose general health and ability to carry out daily activities meets a standard rating of 0 or 1 on the ECOG scale (confirm with trial site), assessed within 7 days before joining
• People whose blood counts, liver function, kidney function, and blood clotting results fall within acceptable ranges as defined by the trial (confirm with trial site for specific values)
• People who are willing and able to use effective contraception during treatment and for 6 months after the last dose, where applicable based on their circumstances and those of their partner
• People who are willing to take part, sign the consent form, and follow the trial visit schedule and procedures

Who may not be able to join:

• People whose lung cancer includes a squamous cell carcinoma component, or whose cancer also involves small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma
• People with known spread of cancer to the membranes around the brain or spinal cord (with some possible exceptions for very limited, symptom-free cases — confirm with trial site), spread to the brainstem or spinal cord, or active brain metastases
• People who have previously received any cancer treatment other than osimertinib for their advanced or metastatic NSCLC
• People who have previously received any treatment targeting a protein called TROP2, or any treatment targeting an enzyme called topoisomerase I (including certain antibody-drug combinations)
• People who have had another cancer within the past 3 years, unless it was a fully cured skin cancer or early-stage cervical cancer
• People with certain serious heart or blood vessel conditions, including a heart attack, unstable chest pain, serious heart failure, poorly controlled heart rhythm problems, stroke, or blood clots in the legs, lungs, or arteries within recent months, or a history of heart muscle disease, or an abnormal heart rhythm measurement on an ECG (confirm with trial site for timeframes and specific conditions)
• People with poorly controlled diabetes, poorly controlled high blood pressure, or fluid build-up around the lungs, heart, or abdomen that requires drainage more than once a week
• People with a history of serious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or who currently have or are suspected to have this condition
• People with severe dry eye conditions, serious eyelid or gland disease, or a history of corneal problems that affect healing
• People with severely reduced lung function due to complications, or who have had a full lung removed
• People with active inflammatory bowel disease, bowel blockage, serious ulcers, a hole in the gut wall, an abdominal abscess, or active gastrointestinal bleeding
• People with digestive conditions that could significantly affect how the body absorbs osimertinib, such as chronic nausea, inability to swallow tablets, or major bowel surgery
• People whose tumour is pressing on or growing into nearby vital structures such as the heart or major blood vessels, causing symptoms, or where there is a risk of an abnormal opening forming between the oesophagus and the airway or chest cavity
• People who still have significant side effects from previous cancer treatments that have not recovered to an acceptable level
• People who have had a serious infection within 4 weeks before joining, or an active infection requiring treatment within 2 weeks before joining
• People with known active tuberculosis
• People with active hepatitis B or hepatitis C infection based on specific blood test results (confirm with trial site for exact thresholds)
• People who test positive for HIV or have a history of AIDS, or who have an active syphilis infection
• People who have had an organ transplant or bone marrow/stem cell transplant from another person
• People who have had major surgery within 4 weeks before joining, or who are expected to need major surgery during the trial
• People with a known allergy to the study drug or its ingredients, or a history of severe allergic reactions to other antibody-based medicines
• People currently taking certain medications or herbal supplements that strongly affect how the body processes drugs through a liver enzyme called CYP3A4, and who cannot stop taking them before starting the trial (confirm with trial site for specific medicines)
• People who have received high-dose radiation to the lungs within 6 months before joining, or high-dose radiation to other areas within 4 weeks before joining (palliative radiation for symptom relief may be acceptable if completed at least 2 weeks prior — confirm with trial site)
• People who have received a live vaccine within 30 days before joining, or who plan to receive one during the trial
• People whose health has declined rapidly during the screening period before starting treatment
• People who are pregnant or breastfeeding
• People who have any other condition that, in the treating doctor's judgement, would make participation unsafe or affect the reliability of trial results

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