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:

• Adults aged 18 or older, of any gender
• People who have been confirmed through lab testing (tissue or cell samples) to have small cell lung cancer (SCLC)
• People whose cancer got worse after receiving at least 4 cycles of a standard first-line chemotherapy combination (etoposide plus a platinum-based drug), with the worsening happening between 30 days and 6 months after completing that treatment; people with limited-stage SCLC must also meet certain tumour stage requirements (confirm with trial site)
• People who have at least one measurable or detectable tumour lesion, as assessed using standard imaging guidelines
• People whose doctors expect them to survive for at least 3 months
• People who are reasonably active and able to care for themselves, with a performance score below 2 on a standard scale used by doctors (ECOG score)
• People with no liver spread, OR with 3 or fewer liver tumours each no larger than 1.5 cm, OR with larger liver tumours that have been treated locally and shown to be stable on scans for at least 3 weeks
• People with brain metastases (cancer that has spread to the brain) only if all of the following apply: the brainstem is not affected, there are 2 or fewer brain tumours, the brain tumours have been stable on scans for at least 3 weeks after local treatment, no water-reducing or steroid medications have been used recently, and there are no symptoms from the brain tumours; people whose only measurable tumour sites are in the brain are not eligible
• People whose blood, liver, kidney, and clotting function all meet the specific healthy ranges required by the trial at the time of screening (confirm exact values with trial site)
• People who have fully understood the study and have signed a consent form agreeing to take part
• Women who could become pregnant, and men whose partners could become pregnant, who agree to use reliable contraception during the study and for 6 months after the last dose of the study drug

Who may not be able to join:

• People whose lung cancer has been diagnosed as a combined or compound type of small cell lung cancer
• People whose cancer has spread to the membranes around the brain or spinal cord, or who have spinal cord compression
• People with symptomatic or rapidly worsening blockage of the large vein in the chest (superior vena cava syndrome) that may need non-medication treatment, or people with large amounts of uncontrolled fluid build-up around the lungs, abdomen, or heart
• People who have an active infection (including tuberculosis) that requires antibiotic, antifungal, or antiviral treatment at the time of screening
• People with recurring, poorly controlled chronic obstructive pulmonary disease, or widespread lung tissue disease such as interstitial pneumonia or pulmonary fibrosis
• People with severe radiation-related lung damage, blood clots in the lungs, active significant coughing up of blood, or serious bowel and digestive conditions such as bleeding, blockage, unhealed ulcers, inflammatory bowel disease, or diarrhoea above a mild level
• People with uncontrolled high blood pressure (readings of 160/100 mmHg or above), a history of hypertensive crisis or hypertensive brain injury, unstable serious heart rhythm problems, or people who have had a heart attack, unstable chest pain, heart surgery or stenting, significant heart failure, blood clots in the veins or lungs, active stroke, or active brain bleeding within the past 6 months
• People who test positive for active hepatitis B virus (with virus levels at or above a certain threshold), active hepatitis C virus (with virus levels at or above a certain threshold), or HIV
• People who have had another cancer in the past 5 years, except for certain fully cured early-stage cancers such as early cervical cancer, certain skin cancers, or surgically removed non-invasive cancers
• People with serious conditions affecting other major organ systems that the trial doctors consider make participation unsuitable
• People who have previously been treated with irinotecan, topotecan, or any other drug from the same class (topoisomerase I inhibitors)
• People with a known allergy to irinotecan hydrochloride liposomes, its ingredients, related compounds (such as camptothecin-type drugs), other liposomal drugs, or topotecan
• People who have received a live or live-attenuated vaccine before screening (confirm timeframe with trial site)
• People who have received any systemic cancer treatment within 4 weeks before being assigned to a study group
• People who have taken part in another clinical trial using an investigational drug or device before being assigned to a study group
• People who have recently used certain medications that strongly affect how the body processes the study drug (strong CYP3A4 inducers or inhibitors, or strong UGT1A1 inhibitors) — confirm with trial site
• People who still have side effects from previous cancer treatment that have not recovered to a mild level or resolved, except for hair loss or mild nerve-related symptoms
• People with a history of drug misuse or alcohol dependency
• People who are pregnant or breastfeeding
• People with unstable neurological conditions, mental health disorders, or any other condition that the trial doctors consider makes participation unsuitable

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