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:

• You are willing to take part and have signed a consent form agreeing to participate
• You are aged between 18 and 75 years old (male or female)
• Your doctors expect you to live for at least 3 more months
• You are generally able to carry out normal daily activities with little or no limitation (confirm with trial site)
• You have been newly diagnosed with extensive-stage small cell lung cancer, confirmed by a tissue or cell sample test
• You can provide a tumour tissue sample (either stored or freshly taken) from within the last 3 years
• You have at least one tumour that can be measured on a scan, according to standard criteria
• You have not had a blood transfusion or certain blood-boosting medications in the 14 days before screening, and your organs are functioning at a required level
• Any side effects from previous cancer treatment have mostly resolved or are very mild
• If you are a woman who could become pregnant: you must have a negative pregnancy test within 7 days of starting treatment, not be breastfeeding, and use reliable contraception throughout treatment and for 6 months afterwards

Who may not be able to join:

• You have previously been treated with a specific type of targeted drug called an ADC that uses a topoisomerase I inhibitor as its active component (confirm with trial site)
• You have already received any systemic (whole-body) anti-cancer treatment for extensive-stage small cell lung cancer
• Your biopsy results show your cancer contains a mix of small cell and non-small cell lung cancer
• You have taken immune-modifying drugs in the 14 days before your first study dose
• You have had a serious heart or stroke-related event in the 6 months before screening
• You have certain heart rhythm problems, including a prolonged QT interval, complete left bundle branch block, third-degree heart block, or frequent uncontrolled irregular heartbeat
• You have an active autoimmune disease or inflammatory condition
• You are currently taking long-term steroid tablets or other immune-suppressing medicines
• You have had another cancer that has been active or required treatment within the last 5 years
• You have a lung condition called interstitial lung disease (ILD), are currently being treated for it with steroids, or are suspected of having it
• You have poorly controlled diabetes, serious diabetes complications, a blood sugar control level (HbA1c) of 8% or more, high blood pressure not controlled by two medications, or a history of hypertensive crisis or related brain condition
• You have had a serious blood clot requiring treatment within the 6 months before screening (except clots related to IV lines)
• You have another lung disease causing serious breathing problems
• Your cancer has spread to your brain and is currently active
• You have large, symptomatic, or poorly controlled fluid build-up around your organs (such as around the lungs or heart)
• You have a known allergy to the type of antibody used in the trial drug or any of its ingredients
• You have previously had an organ transplant or a bone marrow/stem cell transplant from a donor
• You have HIV, active tuberculosis, active hepatitis B, or active hepatitis C
• You have had a serious infection, or a lung infection or lung inflammation, within 4 weeks before your first dose
• You have taken part in another clinical trial within the 4 weeks before your first dose
• You have a history of substance abuse that cannot be managed, or a serious neurological or psychiatric condition
• Scans show the tumour has grown into or wrapped around major blood vessels in the chest
• You have had a wound, ulcer, or broken bone that has not healed within 4 weeks of signing the consent form
• You have had significant bleeding or a clear tendency to bleed within 4 weeks of signing the consent form
• You have received or are scheduled to receive a live vaccine within 28 days before your first dose
• Your doctor considers there to be any other reason you should not take part

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