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 and able to sign a written consent form before any study procedures begin
• People who are 18 years of age or older at the time of signing the consent form
• People who weigh at least 50 kg at the screening visit
• People who have been newly diagnosed with advanced (stage IV) non-squamous non-small cell lung cancer (a specific type of lung cancer) with no prior systemic treatment for this disease — and, if fluid around the lungs or heart is the only sign of spread, confirmation that the fluid is cancer-related is required
• People who have at least one tumour that can be measured on a scan, assessed by a local medical team
• People whose tumour tests show a PD-L1 expression level of 50% or higher, measured using an FDA-approved testing method
• People with a life expectancy of at least 3 months
• People with a general health and activity level rated as 0 or 1 on the ECOG scale, meaning fully active or able to carry out light work (confirm with trial site)
• People whose liver, kidney, blood, thyroid, and clotting test results fall within acceptable ranges as defined by the trial (confirm specific values with trial site)
• People with a negative COVID-19 test taken within 24 hours before being assigned to a treatment group, or — if a past COVID-19 infection was confirmed — documentation showing the infection has resolved
• People with no history of other cancers, except for certain skin cancers, superficial bladder cancer, or cervical cancer in situ, or people who received treatment for another cancer at least 3 years ago with no signs of it returning
• Women who could become pregnant must either abstain from sexual intercourse or use two highly effective forms of contraception during the study and for at least 6 months after the last dose; women who are post-menopausal or have had surgery that prevents pregnancy are also eligible
• Women in the trial must not donate or store eggs during treatment and for 6 months after the last dose
• Men who are not surgically sterile must either abstain from sexual intercourse or use effective contraception during the study and for at least 6 months after the last dose, and must not donate semen during this time

Who may not be able to join:

• People who are unwilling or unable to follow the study schedule, take the study drug as planned, or complete required tests and procedures
• People whose lung cancer is primarily the squamous cell type, or whose cancer includes small cell elements
• People who have taken part in another clinical trial or received an experimental treatment within 4 weeks (or 5 half-lives of that drug, whichever is longer) before being assigned to a treatment group
• People whose cancer has a known genetic mutation for which an approved and available targeted treatment already exists
• People with known cancer that has spread to the brain or the lining around the brain or spinal cord
• People who have received systemic steroid treatment (prednisone 10 mg or equivalent) within 3 days before the first study dose, or who are currently taking other immune-suppressing medications — though people on low-dose daily steroid replacement therapy may still be considered
• People who need any other cancer treatment during the study
• People who have previously received certain types of immunotherapy treatments, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 drugs (such as ipilimumab)
• People who have had systemic chemotherapy, biological therapy, or major surgery within 3 weeks before the first dose, or chest radiation above a certain dose within 6 months before the first dose (palliative radiation completed more than 14 days before is allowed)
• People with a known history of severe allergic reaction to another monoclonal antibody (a type of biological drug)
• People with an active autoimmune disease that has required systemic treatment within the last 2 years — hormone or gland replacement therapies are not considered systemic treatment for this purpose
• People with interstitial lung disease or lung inflammation (pneumonitis) that requires steroid treatment
• People with a current active infection, or who have had a serious infection requiring intravenous antibiotics within 30 days before the first dose
• People who have received or are about to receive a live virus vaccine within 30 days before the first dose — non-live flu and COVID-19 vaccines are permitted
• People with a known history of HIV-1 or HIV-2
• People with active tuberculosis, active hepatitis B, or active hepatitis C infection
• People who have received a solid organ or tissue transplant from another person
• People with known psychiatric conditions that could prevent them from following study requirements
• People who regularly use illicit drugs or have had a substance or alcohol problem within the past year
• People who are pregnant, breastfeeding, or planning to become pregnant during the study or within 120 days after the last dose
• People who are an immediate family member of someone working at the research site or at the company sponsoring this study, where that person is directly involved in the trial

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