Can a targeted drug combo outperform standard chemo for tough lung cancer?
NCT ID NCT07739758
First seen Jul 31, 2026 · Last updated Aug 25, 2026 · Updated 2 times
Summary
This trial is testing whether a new experimental drug called YL201, when combined with the immunotherapy serplulimab, can help people with extensive-stage small cell lung cancer live longer compared to the current standard treatment (carboplatin and etoposide plus serplulimab). The study enrolls adults who have not received prior systemic treatment for this advanced cancer. Participants are randomly assigned to one of the two treatment groups, and the main goals are to measure overall survival and progression-free survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- YL201 (an experimental antibody-drug conjugate) combined with serplulimab (an immunotherapy)
- What this could lead to
- If successful, this combination could become a new first-line treatment option for extensive-stage small cell lung cancer, potentially improving survival compared to current standard care.
- What could go wrong
- This is a phase III trial, but results are not yet known. The experimental drug may not prove more effective or could cause unexpected side effects. Success in earlier phases does not guarantee final approval.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 442 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily sign the written informed consent form and comply with the protocol requirements 2. Age ≥18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC). 5. No prior systemic treatment for ES-SCLC. 6. At least one extracranial measurable lesion according to RECIST v1.1. 7. Adequate organ function. 8. Life expectancy ≥3 months. Exclusion Criteria: 1. Any histological types of transformed SCLC or combined SCLC. 2. History of immune-related adverse events (irAEs) of CTCAE Grade ≥3 during prior immunotherapy, or unresolved adverse events from previous antitumor therapy. 3. Major surgery (excluding diagnostic procedures) or severe trauma within 4 weeks prior to randomization or planned major surgery during the study period. 4. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 5. Presence of active brain metastases, brainstem metastases, or leptomeningeal metastases. 6. Presence of severe and uncontrolled cardiovascular or cerebrovascular disease. 7. 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. 8. Active autoimmune or inflammatory diseases within 2 years prior to randomization. 9. Severe infection within 4 weeks prior to randomization, or active infection requiring intravenous anti-infective therapy within 2 weeks or oral anti-infective therapy within 1 week prior to randomization. 10. Known active tuberculosis or active syphilis infection. 11. History of immunodeficiency or positive for human immunodeficiency virus (HIV) antibodies test. 12. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Participants with inactive HBV infection must receive antiviral therapy throughout the study. 13. History of other primary malignancies within 5 years prior to randomization. 14. Known hypersensitivity to any component of the investigational product. 15. Females who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the study period. 16. Any condition that, in the opinion of the investigator, would make the participant unsuitable for study participation.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Liaoning Cancer Hospital & Institute
RECRUITINGShenyang, Liaoning, 110042, China
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
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- New drug combo aims to outperform standard care in aggressive lung cancer
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- New combo therapy targets tough lung cancer in early trial