A Study of YL201 in Combination With Serplulimab in Participants With Treatment-naïve Extensive-s… (NCT07739758) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study of YL201 in Combination With Serplulimab in Participants With Treatment-naïve Extensive-stage Small Cell Lung Cancer
China442 participantsStarted 2026-08
Plain-language summary
This trial is a registrational Phase III, randomized, open-label, multicenter study to compare the efficacy and safety of YL201 in combination with serplulimab versus standard-of-care carboplatin and etoposide in combination with serplulimab as first-line treatment in patients with extensive-stage small cell lung cancer.
Who can participate
Age range
18 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
. Voluntarily sign the written informed consent form and comply with the protocol requirements
. Age ≥18 years.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
. No prior systemic treatment for ES-SCLC.
. At least one extracranial measurable lesion according to RECIST v1.1.
. Adequate organ function.
. Life expectancy ≥3 months.
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
Overall survival (OS)
Timeframe: Up to approximately 5 years
2
Progression-free survival (PFS) as assessed by BIRC
. Any histological types of transformed SCLC or combined SCLC.
. History of immune-related adverse events (irAEs) of CTCAE Grade ≥3 during prior immunotherapy, or unresolved adverse events from previous antitumor therapy.
. Major surgery (excluding diagnostic procedures) or severe trauma within 4 weeks prior to randomization or planned major surgery during the study period.
. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
. Presence of active brain metastases, brainstem metastases, or leptomeningeal metastases.
. Presence of severe and uncontrolled cardiovascular or cerebrovascular disease.
. History of interstitial lung disease (ILD) /pneumonitis requiring steroid treatment, or current diagnosis of ILD/pneumonitis, or concurrent pulmonary disease leading to clinically severe impairment of respiratory function.
. Active autoimmune or inflammatory diseases within 2 years prior to randomization.