Phase 3 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 are willing to sign a consent form before any screening begins.
• People aged 18 or older, of any gender.
• People who are generally well enough to carry out light activity or desk work (a measure of overall health and activity level scored 0 or 1 on a standard scale).
• People with a life expectancy of at least 3 months.
• People who have been confirmed through tissue or cell testing to have a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC) that is advanced or has spread, and cannot be treated with surgery or a combination of chemotherapy and radiation with the aim of cure.
• People with certain subtypes of NSCLC (non-squamous, or non-smokers with a mixed type) who have been confirmed through testing to not have specific gene changes called EGFR mutations or ALK rearrangements.
• People whose tumour tissue is suitable for a specific protein test (called PD-L1), and whose result on that test is 10% or higher.
• People who have not previously received any systemic (whole-body) treatment for this cancer.
• People who have at least one measurable tumour outside the brain, as defined by standard measurement guidelines.
• People whose major organs (such as liver, kidneys, and heart) are functioning adequately.

Who may not be able to join:

• People whose cancer has specific known gene changes, such as ROS1 fusion, BRAF V600E mutation, NTRK fusion, MET exon 14 skipping mutation, or RET fusion.
• People who have received certain immune-modifying or immune-suppressing medications within the 2 weeks before their first dose, or certain traditional herbal medicines used for cancer within 1 week before first dose.
• People who have previously had radiation therapy to the chest area, or who have received any local cancer treatment within 2 weeks before their first dose.
• People who have previously been treated with immunotherapy, anti-blood-vessel-growth therapy, or certain targeted cancer medicines known as tyrosine kinase inhibitors (TKIs).
• People whose cancer has spread to or is pressing on the brainstem, the lining of the brain, or the spinal cord, or who have active brain metastases or multiple tumours in the brain.
• People whose scans show the tumour is growing into major blood vessels, has significant areas of decay or hollowing within it, or has spread through the lymph vessels of the lungs.
• People whose scans show the tumour is growing into or pressing on nearby vital organs, or where there is a risk of an abnormal opening forming between the food pipe and the airway or chest cavity.
• People with a history of severe high blood pressure episodes or high blood pressure affecting the brain, or whose high blood pressure or diabetes cannot be adequately controlled with medication.
• People who have had a blood clot in an artery or deep vein, a stroke, a mini-stroke, or serious blood vessel disease within the 6 months before joining.
• People who have had a heart attack, unstable chest pain, significant heart failure, or severe uncontrolled irregular heart rhythm within the 6 months before joining.
• People who have an active autoimmune disease, or a history of one that is likely to come back.
• People who have had varicose veins in the oesophagus or stomach, severe ulcers, abnormal internal openings, abscesses in the abdomen, a hole in the gut, serious gut bleeding, bowel blockage, or extensive bowel removal within the 6 months before their first dose.
• People with a tendency to bleed, a high risk of bleeding, or problems with blood clotting.
• People who have another active cancer diagnosis.
• People who still have significant side effects (above a mild level) from previous cancer treatments such as surgery, radiation, or chemotherapy.
• People who have received a live or weakened live vaccine within 4 weeks before their first dose, or who plan to receive one during the trial period (inactivated vaccines are permitted).
• People with certain active or recent infections, including a severe infection in the past 4 weeks, an active infection in the past 2 weeks, active tuberculosis, a positive HIV test, active hepatitis B or C, or known active syphilis.
• People who are planning or expected to have major surgery during the trial, or who have wounds that have not yet healed before joining.
• People with ongoing fluid build-up around the lungs, heart, or in the abdomen that requires drainage.
• People with a history of non-infectious lung inflammation that required treatment, or who have a chronic scarring or inflammatory lung condition.
• People who have previously received a transplanted organ or bone marrow/stem cells from another person.
• People who are known to be allergic to any ingredient in the trial drug, or who have had a severe allergic reaction to a similar type of medicine (monoclonal antibody).
• People who are currently taking part in another interventional clinical trial (observational studies or follow-up phases of previous trials may be acceptable — confirm with trial site).
• People who are pregnant or breastfeeding.
• People with a known history of alcohol or drug dependency, psychiatric illness, or substance misuse.
• People whose cancer is causing conditions or symptoms considered to carry a high medical risk (confirm with trial site).
• People whom the trial investigators consider unsuitable for any other reason.

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