Small Cell Lung CancerPhase 3NCT06612151
A Phase III Study of YL201 in Relapsed Small Cell Lung Cancer (TAISHAN-302)
A Phase 3 study testing YL201 and topotecan hydrochloride for injection in people with Small Cell Lung Cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
This study was designed to compare the efficacy and safety of YL201 with Topotecan Hydrochloride in subjects with relapsed small cell lung cancer (SCLC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- YL201 and topotecan hydrochloride for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2024to 1 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
- Aged ≥18 and ≤75 years, male or female.
- ECOG PS 0 or 1.
- Life expectancy ≥ 3 months.
- Histologically or cytologically confirmed SCLC. Subjects with combined SCLC or any transformed SCLC are not eligible.
- Has limited-stage or extensive-stage disease at study entry, with progression on or after first-line platinum-based therapy (at least 2 cycles).
Show all 9Show fewer
- At least one measurable lesion according to RECIST version 1.1.
- Subjects are willing to provide tumor tissue (freshly obtained or archived) for detection of B7-H3 expression.
- Adequate organ function.
Who cannot join
- History of other malignant tumors within 5 years prior to the first dose of study drug. Subjects cured by radical treatment are not included, such as basal cell carcinoma, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of the cervix, or breast cancer in situ.
- Previously received B7-H3-targeted therapy, including antibody, antibody-drug conjugate (ADC), and chimeric antigen receptor T cell (CAR-T).
- Previously received treatment with a topoisomerase I inhibitor or an ADC consisting of a topoisomerase I inhibitor.
- Inadequate washout period for prior anti-tumor treatment before the first dose of study drug.
- Received systemic steroids or other immunosuppressive therapy within 2 weeks before the first dose of study drug.
- Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study.
Show all 20Show fewer
- Presence of brain stem or meningeal metastases, spinal cord metastases or compression.
- Presence of central nervous system (CNS) metastasis. Participants with treated brain metastases are eligible if the metastases are asymptomatic and stable, and no immediate local or systemic treatment is needed within 2 weeks before the first dose.
- Presence of pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
- Has an uncontrolled concurrent disease.
- Presence of severe uncontrolled cardiovascular disorder.
- History of interstitial lung disease (ILD) or pneumonitis that required corticosteroids, or current ILD/pneumonitis
- Concomitant pulmonary disorder leading to clinically severe respiratory impairment.
- Chronic autoimmune or inflammatory diseases requiring or receiving systemic therapy within 2 years prior to the first dose.
- Serious infections within 4 weeks prior to the first dose.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Unresolved toxicities from previous antitumor therapy.
- Known hypersensitivity to any component of any study drug; history of severe allergy or known history of serious hypersensitivity to other monoclonal antibodies or recombinant protein products, or history of severe infusion reactions.
- Pregnancy, breastfeeding, or women planning to become pregnant or breastfeed during the study.
- Any illness, medical condition, organ system dysfunction, or social situation deemed by the investigator to be likely to interfere with a subject's ability to sign informed consent, adversely affect the subject's ability to cooperate and participate in the study, or compromise the interpretation of study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Controlled, Open-label, Phase III Study to Compare the Efficacy and Safety of YL201 Versus Topotecan Hydrochloride in Subjects With Relapsed Small Cell Lung Cancer
This study was designed to compare the efficacy and safety of YL201 with Topotecan Hydrochloride in subjects with relapsed small cell lung cancer (SCLC).
Read the detailed description
The primary objective of this study is to assess whether treatment with YL201 prolongs overall survival (OS) compared with treatment of topotecan hydrochloride among subjects with relapsed SCLC.
The secondary objectives of the study are to further evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of YL201, and the correlation between B7-H3 expression level and the efficacy of YL201.
- Conditions
- Small Cell Lung Cancer
- Being tested
- YL201, topotecan hydrochloride for injection
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YL201Drug
Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle at RP3D dose level.
topotecan hydrochloride for injectionDrug
Topotecan hydrochloride will be administered intravenously per prescribing information.
| Study group | Role | What they receive |
|---|---|---|
| YL201 | Experimental | Participants are randomized to receive YL201 monotherapy intravenously on Day 1 of each 3-week cycle at RP3D dose level, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent as specified in the protocol. Receives: Drug: YL201 |
| topotecan hydrochloride for injection | Active comparator | Participants are randomized to receive topotecan hydrochloride intravenously, on Days 1 to 5 of each 3-week cycle per prescribing information, until PD, unacceptable toxicity, or withdrawal of consent as specified in the protocol. Receives: Drug: topotecan hydrochloride for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the OS of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.
(OS) defined as the time interval from the first randomization to death due to any cause.
Measured: Approximately within 36 months
Secondary outcomes (15)
To compare Investigator-assessed progression-free survival (PFS) of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.
PFS defined as the time interval from randomization to the first documented PD or death due to any cause, whichever occurs first.
Measured: Approximately within 36 months
To compare Investigator-assessed objective response rate (ORR) of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.
ORR defined as the proportion of subjects who achieve a best overall response (BOR) of complete response (CR) or partial response (PR).
Measured: Approximately within 36 months
To compare duration of response (DoR) as assessed by the investigator of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.
DoR defined as the time interval from the first documentation of response (CR or PR) to the first documentation of PD or death, whichever occurred first.
Measured: Approximately within 36 months
To compare time to response (TTR) as assessed by the investigator of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.
TTR defined as the time interval from randomization to the first documentation of response (CR or PR).
Measured: Approximately within 36 months
To compare disease control rate (DCR) assessed by the investigator of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.
DCR defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD).
Measured: Approximately within 36 months
To evaluate the incidence and severity of adverse events (AEs) of YL201.
AEs are assessed based on NCI CTCAE v5.0.
Measured: Approximately within 36 months
To evaluate the concentration-time data for YL201, total antibody, and payload
Measured: Approximately within 36 months
To characterize the PK parameter AUC
Measured: Approximately within 36 months
Characterize the PK parameter Cmax
Measured: Approximately within 36 months
To characterize the PK parameter Ctrough
Measured: Approximately within 36 months
To characterize the PK parameter CL
Measured: approximately within 36 months
Characterize the PK parameter Vd
Measured: approximately within 36 months
Characterize the PK parameter t1/2
Measured: Approximately within 36 months
Assessment of B7H3 expression level in tumor tissue and the correlation between the expression level and the efficacy of YL201.
Measured: Approximately within 36 months
Assessment of the number of subjects who are Anti-Drug Antibody (ADA)-positive at any time and who have a treatment-emergent ADA
Measured: Approximately within 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start17 Dec 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung CancerStudies 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
- 438 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612151
- Sponsor's protocol ID
- YL201-CN-302-01
- Status last verified
- May 2026
- First submitted
- 23 Sep 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao Y, Liu H, Meng X, Liu Z, Yu Y, Zheng Y, Sun L, Yang R, Liu J, Zhao Y, Wu L, Yang L, Zhang Z, Li M, Zhang P, Zhang Y, Zhong H, Cui J, Huang Z, Yin Y, Li M, Tong F, Xue D, Lv D, Li X, Zhang X, Chin S, Cai J, Xue T, Huang Y, Zhao H, Zhang L; TAISHAN-302 Investigators. Tambotatug Pelitecan in Small-Cell Lung Cancer after Platinum-Based Therapy. N Engl J Med. 2026 Sep 12. doi: 10.1056/NEJMoa2610229. Online ahead of print.
PubMed 42734213
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled, Open-label, Phase III Study to Compare the Efficacy and Safety of YL201 Versus Topotecan Hydrochloride in Subjects With Relapsed Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06612151
- Acronym / sponsor ID
- YL201-CN-302-01
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 438 participants (estimated)
- Lead sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 25 Sep 2024 (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 study was designed to compare the efficacy and safety of YL201 with Topotecan Hydrochloride in subjects with relapsed small cell lung cancer (SCLC).
Detailed description
The primary objective of this study is to assess whether treatment with YL201 prolongs overall survival (OS) compared with treatment of topotecan hydrochloride among subjects with relapsed SCLC.
The secondary objectives of the study are to further evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of YL201, and the correlation between B7-H3 expression level and the efficacy of YL201.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YL201 | Experimental | Drug: YL201Participants are randomized to receive YL201 monotherapy intravenously on Day 1 of each 3-week cycle at RP3D dose level, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent as specified in the protocol. |
| topotecan hydrochloride for injection | Active comparator | Drug: topotecan hydrochloride for injectionParticipants are randomized to receive topotecan hydrochloride intravenously, on Days 1 to 5 of each 3-week cycle per prescribing information, until PD, unacceptable toxicity, or withdrawal of consent as specified in the protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
- Aged ≥18 and ≤75 years, male or female.
- ECOG PS 0 or 1.
- Life expectancy ≥ 3 months.
- Histologically or cytologically confirmed SCLC. Subjects with combined SCLC or any transformed SCLC are not eligible.
Key exclusion criteria (20 listed)
- History of other malignant tumors within 5 years prior to the first dose of study drug. Subjects cured by radical treatment are not included, such as basal cell carcinoma, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of the cervix, or breast cancer in situ.
- Previously received B7-H3-targeted therapy, including antibody, antibody-drug conjugate (ADC), and chimeric antigen receptor T cell (CAR-T).
- Previously received treatment with a topoisomerase I inhibitor or an ADC consisting of a topoisomerase I inhibitor.
- Inadequate washout period for prior anti-tumor treatment before the first dose of study drug.
- Received systemic steroids or other immunosuppressive therapy within 2 weeks before the first dose of study drug.
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 |
|---|---|---|
| YL201Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle at RP3D dose level. | Drug | YL201 |
| topotecan hydrochloride for injectionTopotecan hydrochloride will be administered intravenously per prescribing information. | Drug | topotecan hydrochloride for injection |
Primary outcome
To compare the OS of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.
Time frame: Approximately within 36 months
(OS) defined as the time interval from the first randomization to death due to any cause.
15 secondary outcomes
To compare Investigator-assessed progression-free survival (PFS) of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.
Time frame: Approximately within 36 months
To compare Investigator-assessed objective response rate (ORR) of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.
Time frame: Approximately within 36 months
To compare duration of response (DoR) as assessed by the investigator of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.
Time frame: Approximately within 36 months
To compare time to response (TTR) as assessed by the investigator of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.
Time frame: Approximately within 36 months
To compare disease control rate (DCR) assessed by the investigator of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC.
Time frame: Approximately within 36 months
To evaluate the incidence and severity of adverse events (AEs) of YL201.
Time frame: Approximately within 36 months
To evaluate the concentration-time data for YL201, total antibody, and payload
Time frame: Approximately within 36 months
To characterize the PK parameter AUC
Time frame: Approximately within 36 months
Characterize the PK parameter Cmax
Time frame: Approximately within 36 months
To characterize the PK parameter Ctrough
Time frame: Approximately within 36 months
To characterize the PK parameter CL
Time frame: approximately within 36 months
Characterize the PK parameter Vd
Time frame: approximately within 36 months
Characterize the PK parameter t1/2
Time frame: Approximately within 36 months
Assessment of B7H3 expression level in tumor tissue and the correlation between the expression level and the efficacy of YL201.
Time frame: Approximately within 36 months
Assessment of the number of subjects who are Anti-Drug Antibody (ADA)-positive at any time and who have a treatment-emergent ADA
Time frame: Approximately within 36 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 15 Sep 2026.
- Derived from this study: PubMed 42734213Zhao Y, Liu H, Meng X, Liu Z, Yu Y, Zheng Y, Sun L, Yang R, Liu J, Zhao Y, Wu L, Yang L, Zhang Z, Li M, Zhang P, Zhang Y, Zhong H, Cui J, Huang Z, Yin Y, Li M, Tong F, Xue D, Lv D, Li X, Zhang X, Chin S, Cai J, Xue T, Huang Y, Zhao H, Zhang L; TAISHAN-302 Investigators. Tambotatug Pelitecan in Small-Cell Lung Cancer after Platinum-Based Therapy. N Engl J Med. 2026 Sep 12. doi: 10.1056/NEJMoa2610229. Online ahead of print.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 and topotecan hydrochloride for injection in people with Small Cell Lung Cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 1 site 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 9 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the OS of YL201 versus topotecan hydrochloride in subjects with relapsed SCLC. (time frame: Approximately within 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06612151, which also lists 1 linked publication.
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 15 Sep 2026.