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Can a targeted drug combo outperform standard chemo for tough lung cancer?

NCT ID NCT07739758

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 442 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Liaoning Cancer Hospital & Institute

    RECRUITING

    Shenyang, Liaoning, 110042, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

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