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 are willing to take part voluntarily and sign a consent form.
• Adults aged 18 or older, of any gender.
• People who are generally well enough to carry out daily activities with little to no limitation (a doctor's assessment of overall health and activity level, scored 0 or 1 on a standard scale).
• People whose estimated life expectancy is more than 3 months.
• People who are able to understand and follow the study requirements and attend follow-up appointments.
• People who have been diagnosed with small cell lung cancer (SCLC) confirmed through a tissue or cell sample test.
• People with extensive-stage SCLC (meaning the cancer has spread beyond one lung) whose disease has gotten worse after receiving at least two cycles of a standard chemotherapy combination and an immunotherapy drug (called PD-1/L1 therapy), and who have had no more than two previous treatment courses overall.
• People who agree to provide a tumour tissue sample before treatment starts, for research testing.
• People who have at least one measurable area of cancer that can be tracked using standard imaging guidelines (RECIST v1.1), as assessed by the study doctor.
• People with adequate bone marrow and organ function (confirm with trial site for specific thresholds).

Who may not be able to join:

• People who have been diagnosed with another primary cancer within the past 5 years.
• People previously diagnosed with a combined or transformed type of lung cancer (a specific mixed or changed form of SCLC or non-small cell lung cancer).
• People who have received chemotherapy within 4 weeks before the first study treatment, or radiation, biological therapy, hormonal therapy, immunotherapy, or other cancer treatments within 4 weeks before the first dose.
• People who have previously received or are currently receiving a type of cancer treatment called a topoisomerase I inhibitor, including certain targeted drug therapies (antibody-drug conjugates) that contain this type of agent.
• People with active or unstable cancer spread to the brain (brain metastases that are causing symptoms or have been unstable within the past 4 weeks); people with cancer spread to the membranes around the brain or brainstem; or people with cancer pressing on the spinal cord, even if no symptoms are present.
• People with cancer that has spread into the bone marrow.
• People who have previously received treatment specifically targeting a protein called B7-H3.
• People with serious or uncontrolled heart or blood vessel disease.
• People with moderate to severe lung disease that significantly affects breathing, including certain scarring or autoimmune lung conditions, or people who have had a full lung removed.
• People with a history of non-infectious lung inflammation (interstitial lung disease or pneumonitis) that needed steroid treatment, or who currently have or are suspected to have this condition.
• People with active tuberculosis, autoimmune diseases that are not currently in remission, other immune system deficiencies, or a history of stem cell, bone marrow, or organ transplant from a donor.
• People who have had a serious infection within 4 weeks before the first dose, including infections requiring intravenous antibiotics, blood infections, or severe pneumonia.
• People with uncontrolled fluid build-up in body cavities (such as around the lungs or abdomen) that requires medical drainage.
• People with a known allergy or sensitivity to the study drug or its components, or to related drugs such as topotecan, irinotecan, or paclitaxel.
• Women who are pregnant or breastfeeding, or women and men who are planning to have a child during the study period.

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