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 been confirmed, through a biopsy or cell sample, to have a specific type of advanced lung cancer called squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body (Stage IV)
• People whose cancer can be measured on scans, as assessed by the trial site using standard measurement guidelines
• People who are expected to live for at least 3 months
• People who are generally able to care for themselves and carry out light activity, as measured by a standard health scoring tool (score of 0 or 1), checked within 7 days before being assigned to the trial
• People who can provide either a stored tumour tissue sample or a new biopsy from a tumour area that has not been previously treated with radiation
• People living with HIV, provided their HIV is well controlled with antiretroviral medication
• People who have hepatitis B, provided they have been on hepatitis B antiviral treatment for at least 4 weeks and the virus is undetectable in their blood before joining
• People with a history of hepatitis C, provided the virus is undetectable in their blood at the screening stage
• People who experienced side effects from previous cancer treatments, provided those side effects have mostly resolved to a mild or near-normal level before joining (hormone-related side effects that are being managed with hormone replacement are also acceptable)
• People whose organs (such as kidneys, liver, and bone marrow) are functioning at an adequate level
• For the maintenance phase of the trial only: people whose lung cancer has not progressed after completing the initial treatment phase, confirmed by an independent scan review at around week 12
• For the maintenance phase only: people who still have a general health score of 0 or 1 at the pre-randomisation visit
• For the maintenance phase only: people whose side effects from the initial treatment phase have resolved, with the exception of certain mild ongoing effects such as hair loss, mild fatigue, mild nerve-related symptoms, or managed hormone-related side effects
• For the maintenance phase only: people who did not experience lung inflammation (pneumonitis) or related lung disease during the initial treatment phase

Who may not be able to join:

• People diagnosed with small cell lung cancer, or whose tumour contains small cell elements
• People with a history of severe dry eye syndrome, severe eyelid gland disease, severe eyelid inflammation, or severe corneal disease that affects healing
• People with active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) that requires immune-suppressing medication, or those with a prior history of these conditions
• People with serious, uncontrolled heart or blood vessel conditions — including severe heart failure, unstable chest pain, recent heart attack, uncontrolled irregular heartbeat, or certain heart rhythm abnormalities — occurring within the 6 months before starting the trial
• People living with HIV who have been diagnosed with, or have a history of, Kaposi's sarcoma and/or Multicentric Castleman's Disease
• People who have already received chemotherapy or other targeted or biological cancer treatments for their advanced (metastatic) NSCLC — though prior treatment for earlier-stage lung cancer is allowed if it was completed at least 12 months before the advanced cancer was diagnosed
• People who have previously received certain immunotherapy treatments that target specific immune checkpoint proteins (such as PD-1, PD-L1, or PD-L2), unless that treatment was for earlier-stage lung cancer and was completed at least 12 months before the advanced cancer diagnosis
• People who have previously been treated with a drug-antibody combination (called an ADC) that targets a protein called TROP2
• People who have received high-dose radiation therapy to the lung (more than 30 Gray) within the 6 months before starting the trial
• People who have received any radiotherapy within 2 weeks before starting the trial, or who still have radiation-related side effects requiring steroid treatment
• People who have received a live or live-attenuated vaccine within 30 days before the first dose of the trial treatment
• People who have not fully recovered from a major surgery, or who still have ongoing surgical complications
• People who have previously been treated with a drug-antibody combination (ADC) containing a topoisomerase I inhibitor
• People currently taking strong medications that significantly affect how a specific liver enzyme (CYP3A4) processes drugs, if those medications cannot be stopped during the trial (a 2-week washout period before starting trial treatment is required)
• People who have another cancer that is currently active or has required treatment within the past 3 years
• People whose lung cancer has spread to the brain or the lining around the brain and spinal cord
• People who have had a severe allergic reaction (Grade 3 or higher) to any of the study drugs or their ingredients, or to another biological therapy
• People with an active autoimmune disease that has required systemic (whole-body) treatment within the past 2 years — though hormone replacement therapies such as thyroid medication, insulin, or low-dose steroids are acceptable
• People who have a history of non-infectious lung inflammation (pneumonitis) that required steroid treatment, currently have this condition, or have suspected lung inflammation that cannot be ruled out at screening
• People with an active infection that requires systemic treatment
• People who have had an organ or tissue transplant from another person

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