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 who have given written consent to participate
• People who have been diagnosed with metastatic non-small cell lung cancer confirmed by biopsy
• People whose cancer has a specific gene change (EGFR mutation) that responds to a drug called osimertinib, confirmed by an approved laboratory test on a tumor sample or blood test
• People who have already been treated with a third-generation EGFR-targeting drug and platinum-based chemotherapy, or who are not able to receive platinum-based chemotherapy
• People who have at least one measurable area of cancer that has not previously been treated with radiation
• People who are generally well enough to carry out light activity and care for themselves (confirm with trial site what this means for your situation)
• People aged 18 years or older
• People who are able to swallow tablets or capsules (required for one group of participants only — confirm with trial site)
• People whose liver, kidney, blood, and clotting function meet specific levels as measured by blood and urine tests (the trial site will assess this)
• Women who could become pregnant must have a negative pregnancy test before starting treatment
• Women who could become pregnant must agree to use a highly effective form of contraception from screening until at least 90 days after the last dose of certain study drugs (specific timeframes vary by drug — confirm with trial site)
• Men who have not been sterilised and whose partner could become pregnant, or who have a pregnant or breastfeeding partner, must agree to use barrier contraception for the treatment period and for a set time after the last dose of certain study drugs (specific timeframes vary by drug — confirm with trial site)

Who may not be able to join:

• People whose cancer has a specific type of EGFR gene change (exon 20 insertion) that is not expected to respond to osimertinib (applies to one group of participants only)
• Women who are pregnant or breastfeeding
• People who have taken part in another clinical trial and received an experimental treatment within the past 4 weeks
• People who have previously been treated with a type of immunotherapy drug called an anti-PD-1 inhibitor
• People who have previously received a type of drug called an antibody-drug conjugate (ADC) that targets a protein called TROP2 or uses a topoisomerase I chemotherapy agent (applies to one group of participants only)
• People with a significant history of serious corneal (eye surface) disease (applies to one group of participants only)
• People with high blood pressure that remains poorly controlled (blood pressure repeatedly at or above 150/100 mmHg) despite taking blood pressure medication by mouth
• People who have had major surgery or a serious physical injury within 4 weeks before joining the trial, or who are expected to need major surgery within 4 weeks after the first dose
• People who have had clinically significant bleeding problems within 4 weeks before joining, including coughing up blood, significant nosebleeds, or unstable use of blood-thinning or anti-clotting medications
• People with active autoimmune or inflammatory conditions currently being treated with immune-suppressing medications (certain exceptions may apply — confirm with trial site)
• People with a history of serious heart problems such as unstable chest pain, heart attack, significant heart failure, or unstable blood vessel disease requiring hospitalisation within the past 12 months, or other significant heart conditions
• People with a history of serious stomach or bowel problems such as bleeding ulcers, abdominal abscesses, or bowel obstruction within the past 6 months
• People who have had a stroke, mini-stroke (TIA), or serious arterial blood clot event within the past 12 months
• People who have had a sudden worsening of chronic lung disease (COPD) within 4 weeks before starting treatment
• People whose scans show the cancer is growing into or near major blood vessels or vital structures such as the heart, windpipe, or food pipe, or where there is a significant risk of bleeding or abnormal connections forming between organs
• People with a history of another cancer, unless it was treated with the intent to cure, has shown no signs of returning for at least 2 years, and carries a low risk of coming back (certain skin cancers and pre-cancerous conditions that have been fully treated may be exceptions — confirm with trial site)
• People with brain metastases that are causing symptoms, that show signs of bleeding, or that have been treated with radiation within 7 days before starting the trial; people who may need brain radiation during the first treatment cycle; or people with symptomatic spread of cancer to the lining of the brain
• People who have received a live vaccine or live attenuated vaccine within 4 weeks before starting treatment, or who are expected to need one during the trial
• People who have had a serious infection requiring hospitalisation within 4 weeks before starting treatment, or an active infection requiring antibiotic or antifungal treatment within 2 weeks before starting
• People with pre-existing nerve damage in the hands or feet that is moderate or worse in severity
• People with uncontrolled and symptomatic fluid build-up around the lungs, heart, or in the abdomen (people managed with a drainage tube may still be eligible — confirm with trial site)
• People with a history of lung scarring or inflammation (interstitial lung disease) that required steroid treatment
• People currently taking steroid medications at a dose above 10 mg of prednisone per day (or an equivalent dose of another steroid)
• People with HIV whose virus levels are not well controlled
• People who have had an organ transplant or bone marrow/stem cell transplant from another person
• People with active hepatitis B whose virus levels are not stable or declining on antiviral treatment; people with active hepatitis C
• People with a known allergy to any component of the study drugs, or a history of severe allergic reactions to similar biological drugs
• People with any medical, surgical, or psychological condition that, in the treating doctor's opinion, could interfere with the trial, increase health risks, or make participation not in the person's best interest

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