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 have signed a written consent form before any trial-related procedures begin, and who are willing and able to attend scheduled visits and follow required testing.
• People aged 18 or older.
• People with a general health/activity level rated 0 or 1 on the WHO Performance Status scale (meaning fully active or able to carry out light work).
• People with a life expectancy of more than 12 weeks.
• People with a laboratory-confirmed diagnosis of poorly differentiated neuroendocrine carcinoma (NEC) — specifically large cell type for lung NEC, or large or small cell type for NEC originating outside the digestive system or pancreas — confirmed by a central review process using stored tumour tissue.
• People whose tumour tissue shows a protein called DLL3 present in at least 1% of tumour cells, assessed on stored tumour tissue.
• People whose cancer has continued to grow or spread after one platinum-based chemotherapy treatment.
• People whose cancer cannot be surgically removed and has either spread to nearby areas or to other parts of the body.
• People who have at least one measurable area of cancer that can be tracked on scans, assessed within the required timeframes.
• People whose kidneys, blood cells, and liver are functioning at adequate levels as measured by specific blood tests (confirm with trial site for exact values).
• People who have fully recovered, or nearly fully recovered, from side effects of previous cancer treatments, with only minor lasting effects such as hair loss or skin colour changes being acceptable.
• People who have stored tumour tissue available for central review and research purposes.
• People who are free from unstable health conditions and have no personal, family, social, or geographical circumstances that would make it difficult to follow the trial schedule.
• Women who could become pregnant and are sexually active with a male partner who has not had a sterilisation procedure must use a highly effective form of contraception for 28 days before the first dose and for 7 months after the last dose, and must not donate eggs during that period (periodic abstinence, the rhythm method, and withdrawal are not accepted as sufficient methods).
• Men who are sexually active with women who could become pregnant must use contraception for 6 months after the last dose.
• People who are covered by a national health insurance scheme.

Who may not be able to join:

• People diagnosed with a well-differentiated neuroendocrine tumour (NET grade 1, 2, or 3, or typical/atypical carcinoid tumour).
• People who have previously received a treatment that targets the DLL3 protein.
• People who have received more than one line of systemic (whole-body) treatment for metastatic disease (chemotherapy given at an earlier, non-metastatic stage may not count as the first line if there was a gap of at least 6 months before metastatic treatment began — confirm with trial site).
• People with small cell lung NEC, unless it makes up less than 30% of a mixed tumour type.
• People with lung NEC who have certain specific genetic changes (known as EGFR activating mutations, or ALK or ROS1 rearrangements).
• People with untreated or actively symptomatic cancer spread to the brain or central nervous system; however, people with stable, symptom-free brain metastases that have been treated and meet specific criteria may still be considered (confirm with trial site).
• People with cancer spread to the membranes lining the brain and spinal cord (leptomeningeal metastasis).
• People with a recent history of another cancer, except for certain skin cancers that have been adequately treated, cancers caught at a very early stage that were fully treated, or solid tumours treated with the intention to cure where there has been no sign of disease for more than 2 years before joining the trial.
• People who have had major surgery within 28 days before starting the trial treatment.
• People who have had a heart attack or significant heart failure within the 12 months before starting the trial treatment.
• People who have had a stroke or a transient ischemic attack (mini-stroke) within the 12 months before starting the trial treatment.
• People showing signs of an uncontrolled or active serious infection within 7 days before the first dose, or who are receiving antibiotic treatment through a drip or injection (though they may be reconsidered once that treatment is complete and symptoms have resolved).
• People with a known allergy or severe sensitivity to any component of the trial treatment.
• People with a history of a primary immune system disorder, an organ transplant requiring ongoing immune-suppressing medication, use of immune-suppressing drugs within 28 days of joining, or a history of severe immune-related side effects from previous immunotherapy.
• People currently being treated for immune-related lung inflammation, pituitary or thyroid disorders, or inflammation of the pancreas linked to immunotherapy.
• People who have previously had infusion reactions or serious immune-related side effects (grade 2 or higher) that led to stopping immunotherapy permanently.
• People who have an indwelling medical tube or drain in place (such as a urinary catheter, biliary drain, chest drain, or similar device).
• People with an immune deficiency diagnosis, or who are currently taking corticosteroids or other immune-suppressing medications within 7 days before the first dose.
• People with known active or chronic hepatitis B or C infection confirmed by blood tests (people who show past exposure to hepatitis in blood tests but do not have active hepatitis may still be considered).
• People known to have HIV infection.
• People who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the trial or within 7 months of the last dose.
• Men who are unwilling to avoid donating sperm during the trial and for 6 months after the last dose.
• People who have received a live or weakened-virus vaccine within 28 days before the first dose, or who plan to receive one during the trial (COVID-19 vaccination should be avoided during screening and at least 14 days before the first dose; certain monkeypox vaccines may be permitted — confirm with trial site).
• People with an active autoimmune disease that has required systemic medical treatment (other than simple hormone replacement) within the past 2 years, or any condition requiring immune-suppressing therapy during the trial.
• People with other serious or uncontrolled medical conditions that could affect their ability to safely participate in the trial.

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