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 who have been diagnosed with advanced non-small cell lung cancer (stage IIIB, IIIC, or IV) that cannot be cured, where a specific protein marker on tumour cells (called PD-L1) is found at 50% or higher, and where doctors consider the person suitable for a first-line treatment called pembrolizumab (a type of immunotherapy) on its own
• People who have at least one tumour that has not been previously treated with radiation and was not biopsied during the screening process, and that can be clearly measured using standard methods
• People who previously received chemotherapy before or after surgery (but not immunotherapy) for an earlier stage of their cancer, as long as that treatment finished more than 12 months before the cancer spread, and more than 12 months before joining the trial
• People who have stored tumour tissue samples available — at least 15 unstained slides or a tumour block — that can be used for testing
• People aged 18 or older at the time of signing the consent form
• People who are reasonably active and able to care for themselves, with only mild limitations on daily activity (this is measured using a standard scale called ECOG, scores 0 to 2)
• People whose blood, liver, and kidney test results meet certain minimum levels of healthy function, as assessed by the trial team

Who may not be able to join:

• People who have previously received immunotherapy drugs that target the PD-1 or PD-L1 pathway, including pembrolizumab
• People who have had another type of cancer in the past, unless it was a non-melanoma skin cancer, certain early-stage (in situ) cancers, or any other cancer where complete remission was achieved at least 2 years before joining the trial
• People with brain metastases (cancer that has spread to the brain) that are causing symptoms or are not well controlled, or who have needed surgery, radiation, or higher-dose steroids for brain metastases within the past 2 weeks
• People with a known history of cancer spreading to the membranes surrounding the brain and spinal cord (leptomeningeal carcinomatosis)
• People with seizures that are not well controlled
• People who have taken immune-suppressing medications within the 28 days before starting treatment, with the exception of low-dose steroids (up to 10 mg prednisone per day or equivalent), nasal or inhaled steroids, or steroid pre-medications given for imaging contrast allergies
• People who have had an active or documented autoimmune or inflammatory condition (such as inflammatory bowel disease, coeliac disease, or certain other immune-related disorders) within the past 2 years — though some milder conditions that do not require systemic treatment may still be eligible (confirm with trial site)
• People with a history of a primary immune system deficiency
• People who have received an organ transplant from another person
• People with serious uncontrolled illnesses, including active infections, uncontrolled heart conditions, uncontrolled high blood pressure, active stomach ulcers, uncontrolled bleeding disorders, or mental health or personal circumstances that would make it difficult to follow study requirements
• People with active tuberculosis, active hepatitis B, active hepatitis C (confirmed by a specific RNA blood test), or HIV infection
• People who are pregnant or breastfeeding
• People who have received a live vaccine within 30 days before starting the trial or within 30 days of receiving pembrolizumab
• People with any other condition that, in the trial doctor's judgement, could affect how the treatment works or how safely results can be interpreted
• People with a known allergy or sensitivity to any ingredient in the study drug
• People who are directly involved in planning or running this trial
• People who, in the trial doctor's judgement, are unlikely to follow the study's procedures and requirements

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