A Study to Investigate the Efficacy and Safety of Ivonescimab Combined With Irinotecan Liposome a… (NCT06478043) | Clinical Trial Compass
CompletedPhase 2
A Study to Investigate the Efficacy and Safety of Ivonescimab Combined With Irinotecan Liposome as Second-line Regimen for SCLC
China60 participantsStarted 2024-10-16
Plain-language summary
This is an open-label, single-arm, prospective phase 2 study, evaluating the efficacy and safety of ivonescimab combined with irinotecan liposome for relapsed small cell lung cancer, who progressed on PD-(L)1 -based first-line therapy.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 to 75 years old (at the time of inform consent obtained).
. Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
. Histologically confirmed SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system).
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. Life expectancy of at least 3 months.
. ES-SCLC who failed first-line platinum-based chemotherapy with checkpoint inhibitors.
. At least one measurable tumor lesion according to RECIST v1.1.
. Adequate organ function.
Exclusion criteria
. Patients with other cancer in 5 years.
. Undergone anti-angiogenic therapy prior to the first dose of study treatment.
. Evidence and history of severe bleeding tendency.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
6-month PFS (progression free survival) rate
Timeframe: From the day treatment started to 6 months
. History of severe active autoimmune disease that has required systemic treatment in the past 2 years, severe drug allergy or have known allergy to any component of the study drugs.
. Active central nervous system (CNS) metastases.
. Active infection requiring systemic therapy.
. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions.