Phase 3 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 signed a dated consent form approved by an ethics board, and who are willing and able to attend scheduled visits and follow the study plan
• People who have been diagnosed with advanced (Stage IV) non-small cell lung cancer (a type of lung cancer), confirmed by tissue or cell sample testing
• People whose tumor tissue has been tested for a protein called PD-L1 at the treating centre
• People with a good general health and activity level, rated 0 or 1 on a standard performance scale (confirm with trial site)
• People who have lost less than 10% of their body weight in the 3 months before joining the study
• People who have not previously received any systemic drug treatment (including targeted therapies) for their advanced or metastatic lung cancer
• People aged 18 years or older and under 75 years
• People with a life expectancy of more than 3 months
• People who have measurable tumour disease visible on a CT or MRI scan
• People for whom enough tumour tissue is available for molecular testing — either a tissue block or at least 7 prepared slides from a non-radiated area (confirm with trial site if tissue availability is uncertain)
• People whose blood tests show that kidneys, blood counts, and liver are functioning at adequate levels (confirm specific values with trial site)
• Women who could become pregnant and are sexually active must use effective contraception starting 28 days before the first dose and continuing for 6 months after the last dose, and must have a negative pregnancy test before starting
• Men who are sexually active with women who could become pregnant must use effective contraception during treatment and for 6 months after the last dose
• People who have national health insurance coverage

Who may not be able to join:

• People with small cell lung cancer, or tumours that contain a small cell lung cancer component (certain other subtypes may still be eligible — confirm with trial site)
• People whose tumour has certain known genetic changes in the EGFR or HER2 genes that drive cancer growth
• People whose tumour has known gene rearrangements in ALK, ROS1, RET, NTRK, or NRG1 genes
• People who have had another cancer in the past 3 years (some exceptions may apply for certain treated skin or cervical cancers, or low-risk localised prostate cancer treated with surgery or radiotherapy — confirm with trial site)
• People with a persisting superior vena cava (a major vein near the heart) blockage that has not improved after stenting
• People who need radiotherapy directed at the tumour at the time treatment begins (palliative radiotherapy for painful bone spread may be permitted with a waiting period — confirm with trial site)
• People with brain spread of the cancer that is causing symptoms and has not been treated with radiotherapy or surgery (asymptomatic brain spread not requiring high-dose steroids may be permitted — confirm with trial site)
• People with a history of a primary immune system disorder, organ transplantation requiring ongoing immunosuppressant medication, use of any immunosuppressant drug in the 28 days before joining, or a history of serious immune-related side effects from a previous immunotherapy treatment
• People currently taking corticosteroid medication (such as prednisone) at a dose higher than 10 mg per day within 14 days before starting treatment (inhaled, nasal, or topical steroids are permitted)
• People with a history of active autoimmune disease such as rheumatoid arthritis, lupus, multiple sclerosis, autoimmune hepatitis, or similar conditions (some milder or well-controlled conditions may be permitted — confirm with trial site)
• People with active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) or serious ongoing digestive disease with uncontrolled diarrhoea
• People with an active uncontrolled infection, including tuberculosis or active hepatitis B or C (some past infections that have fully resolved may be permitted — confirm with trial site)
• People with a known HIV infection
• People who have received a live vaccine in the 30 days before joining
• People who have previously been treated with certain immunotherapy drugs that target PD-1, PD-L1, or CTLA-4
• People who have previously received chemotherapy for lung cancer (a limited exception may apply in certain circumstances — confirm with trial site)
• People with serious uncontrolled heart conditions such as heart failure, irregular heart rhythm, unstable angina, a heart attack in the past 6 months, or a stroke in the past 6 months; people with a significant cardiac history must have adequate heart pumping function on testing
• People who have pre-existing moderate or severe scarring or inflammation of the lung tissue, visible on a CT scan
• People who are unable to comply with the study visits and procedures for personal, social, geographic, or psychological reasons
• Women who are pregnant, currently breastfeeding, or lactating
• People who are detained or held under a judicial or administrative order
• People who are under legal guardianship or who are unable to express their own wishes

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