SCLC, Extensive StagePhase 3NCT07739758
A Study of YL201 in Combination With Serplulimab in Participants With Treatment-naïve Extensive-stage Small Cell Lung Cancer
A Phase 3 study testing YL201, Serplulimab and Carboplatin in people with SCLC, Extensive Stage, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCLC, Extensive Stage
- What is being tested?
- YL201, Serplulimab and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 2 sitesChina
- Study dates
- 18 Aug 2026to Apr 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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.
- Known active tuberculosis or active syphilis infection.
- History of immunodeficiency or positive for human immunodeficiency virus (HIV) antibodies test.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Participants with inactive HBV infection must receive antiviral therapy throughout the study.
- History of other primary malignancies within 5 years prior to randomization.
- Known hypersensitivity to any component of the investigational product.
- Females who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the study period.
- Any condition that, in the opinion of the investigator, would make the participant unsuitable for study participation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Study Coordinator
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042
Study Coordinator
About this study
Official title: A Phase III, Multicenter, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of YL201 in Combination With Serplulimab Versus Carboplatin and Etoposide in Combination With Serplulimab as First-line Treatment in Participants With Treatment-naïve Extensive-stage Small Cell Lung Cancer
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.
- Conditions
- SCLC, Extensive Stage
- Being tested
- YL201, Serplulimab, Carboplatin, Etoposide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YL201Drug
Also called Tam-Peli, Tambotatug Pelitecan
YL201 will be administered by intravenous infusion at a dose of 2.0 mg/kg on Day 1 of each 3-week cycle.
Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first. The total number of treatment cycles of YL201 in this study is not fixed,
SerplulimabDrug
Serplulimab will be administered by intravenous infusion at a dose of 300mg on Day 1 of each 3-week cycle.
Treatment will continue until disease progression or unacceptable toxicity. The maximum treatment duration for serplulimab will be 2 years.
CarboplatinDrug
Carboplatin will be administered by intravenous infusion at a dose of AUC 5 on Day 1 of each 3-week cycle.
Carboplatin treatment will be administered for up to 4 cycles.
EtoposideDrug
Etoposide will be administered by intravenous infusion at a dose of 100 mg/m2 on Days 1 to 3 of each 3-week cycle.
Etoposide treatment will be administered for up to 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| YL201 in combination with serplulimab | Experimental | Participants will receive YL201 in combination with serplulimab until disease progression or unacceptable toxicity, whichever occurs first. The total number of treatment cycles of YL201 in this study is not fixed, and the maximum duration of serplulimab treatment is 2 years. Receives: Drug: YL201; Drug: Serplulimab |
| Carboplatin and etoposide in combination with serplulimab | Active comparator | Participants will receive 4 cycles of carboplatin plus etoposide in combination with serplulimab as induction therapy, followed by maintenance treatment with serplulimab for up to 2 years. Receives: Drug: Serplulimab; Drug: Carboplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. OS was estimated using KM methodology.
Measured: Up to approximately 5 years
Progression-free survival (PFS) as assessed by BIRC
PFS, as assessed by Blinded Independent Review Committee (BIRC), is defined as the time from randomization to the first documented progressive disease (PD) based on BIRC imaging assessment, or death from any cause, whichever occurs first.
Measured: Up to approximately 30 months
Secondary outcomes (8)
Progression-free survival (PFS) as assessed by investigator
PFS assessed by investigator is defined as the time from randomization to the first documented PD based on investigator assessment, or death from any cause, whichever occurs first.
Measured: Up to approximately 30 months
Objective response rate (ORR)
ORR is defined as the percentage of participants with (confirmed) complete response or partial response as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: Up to approximately 30 months
Disease control rate (DCR)
DCR is defined as the percentage of participants with (confirmed) complete response, partial response, or stable disease as assessed according to RECIST v1.1
Measured: Up to approximately 30 months
Duration of response (DOR)
DOR is defined as the time from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first.
Measured: Up to approximately 30 months
Time to response (TTR)
TTR is defined as the time from randomization to the first documented objective response.
Measured: Up to approximately 30 months
Treatment Emergent Adverse Event (TEAE)
Treatment-emergent adverse events (TEAEs) are defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new onset or worsening) that occurs after initiation of YL201, or any worsening of a pre-existing condition during YL201 treatment.
TEAEs will be graded and summarized by type, frequency, and severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 6.0.
Measured: Up to approximately 30 months
Pharmacokinetic (PK) characteristics
PK parameters of YL201 and serplulimab will be evaluated.
Measured: Up to approximately 30 months
Anti-drug antibody (ADA)
Frequency of anti-YL201 antibody (ADA) will be investigated.
Measured: Up to approximately 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start18 Aug 2026
- Primary completionJun 2029 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC, Extensive StageStudies of the same condition, open and under way.
- More trials run by MediLink Therapeutics (Suzhou) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 442 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Henlius Biotech
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739758
- Sponsor's protocol ID
- TAISHAN-304
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of YL201 in Combination With Serplulimab Versus Carboplatin and Etoposide in Combination With Serplulimab as First-line Treatment in Participants With Treatment-naïve Extensive-stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07739758
- Acronym / sponsor ID
- TAISHAN-304
- Conditions
- SCLC, Extensive Stage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 442 participants (estimated)
- Lead sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Henlius Biotech
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YL201 in combination with serplulimab | Experimental | Drug: YL201, Drug: SerplulimabParticipants will receive YL201 in combination with serplulimab until disease progression or unacceptable toxicity, whichever occurs first. The total number of treatment cycles of YL201 in this study is not fixed, and the maximum duration of serplulimab treatment is 2 years. |
| Carboplatin and etoposide in combination with serplulimab | Active comparator | Drug: Serplulimab, Drug: Carboplatin, Drug: EtoposideParticipants will receive 4 cycles of carboplatin plus etoposide in combination with serplulimab as induction therapy, followed by maintenance treatment with serplulimab for up to 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YL201Also: Tam-Peli, Tambotatug PelitecanYL201 will be administered by intravenous infusion at a dose of 2.0 mg/kg on Day 1 of each 3-week cycle. Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first. The total number of treatment cycles of YL201 in this study is not fixed, | Drug | YL201 in combination with serplulimab |
| SerplulimabSerplulimab will be administered by intravenous infusion at a dose of 300mg on Day 1 of each 3-week cycle. Treatment will continue until disease progression or unacceptable toxicity. The maximum treatment duration for serplulimab will be 2 years. | Drug | Carboplatin and etoposide in combination with serplulimab, YL201 in combination with serplulimab |
| CarboplatinCarboplatin will be administered by intravenous infusion at a dose of AUC 5 on Day 1 of each 3-week cycle. Carboplatin treatment will be administered for up to 4 cycles. | Drug | Carboplatin and etoposide in combination with serplulimab |
| EtoposideEtoposide will be administered by intravenous infusion at a dose of 100 mg/m2 on Days 1 to 3 of each 3-week cycle. Etoposide treatment will be administered for up to 4 cycles. | Drug | Carboplatin and etoposide in combination with serplulimab |
Primary outcome
Overall survival (OS)
Time frame: Up to approximately 5 years
OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. OS was estimated using KM methodology.
Progression-free survival (PFS) as assessed by BIRC
Time frame: Up to approximately 30 months
PFS, as assessed by Blinded Independent Review Committee (BIRC), is defined as the time from randomization to the first documented progressive disease (PD) based on BIRC imaging assessment, or death from any cause, whichever occurs first.
8 secondary outcomes
Progression-free survival (PFS) as assessed by investigator
Time frame: Up to approximately 30 months
Objective response rate (ORR)
Time frame: Up to approximately 30 months
Disease control rate (DCR)
Time frame: Up to approximately 30 months
Duration of response (DOR)
Time frame: Up to approximately 30 months
Time to response (TTR)
Time frame: Up to approximately 30 months
Treatment Emergent Adverse Event (TEAE)
Time frame: Up to approximately 30 months
Pharmacokinetic (PK) characteristics
Time frame: Up to approximately 30 months
Anti-drug antibody (ADA)
Time frame: Up to approximately 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YL201, Serplulimab and Carboplatin in people with SCLC, Extensive Stage, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MediLink Study Team (+86 512 62858368, clinicaltrials@medilinkthera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Up to approximately 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.