Relapsed Small Cell Lung Cancer (SCLC)NCT07874581
Effectiveness and Safety of MRG003 (Becotatug Vedotin) in Relapsed SCLC
A study testing MRG003 (Becotatug Vedotin) in people with Relapsed Small Cell Lung Cancer (SCLC), run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
This is a single-center, single-arm, exploratory clinical study evaluating the efficacy and safety of MRG003 (Becotatug Vedotin) in patients with relapsed small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Small Cell Lung Cancer (SCLC)
- What is being tested?
- MRG003 (Becotatug Vedotin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to Dec 2029
- Phase
- Interventional
- 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
- Signed informed consent form (ICF);
- Age ≥18 years at the time of signing informed consent;
- Histologically confirmed small cell lung cancer (SCLC);
- Extensive-stage SCLC (ES-SCLC) with disease progression or recurrence after prior treatment;
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigator;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
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- Adequate organ and bone marrow function.
- Women of childbearing potential must use highly effective contraception from screening until 3 months after discontinuation of study treatment and must have a negative pregnancy test (serum or urine) within 7 days before enrollment. Male participants must agree to use appropriate contraception from screening until 3 months after discontinuation of study treatment or have undergone surgical sterilization;
- No anticancer therapy was received within the specified washout period before the first dose of study treatment;
- Estimated life expectancy ≥12 weeks.
Who cannot join
- Known hypersensitivity to becotatug vedotin;
- History of another active malignancy requiring treatment or history of allogeneic organ transplantation;
- Major surgery (excluding diagnostic biopsy) within 4 weeks before the first dose of study treatment;
- History of drug abuse, chronic alcohol abuse, AIDS, or HIV infection;
- Active autoimmune disease or history of autoimmune disease with potential risk of recurrence;
- Current systemic corticosteroid therapy (e.g., prednisone equivalent >10 mg/day) or use of any other immunosuppressive therapy within 14 days before the first dose of study treatment;
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- Interstitial lung disease (ILD), or previous ILD requiring corticosteroid treatment;
- History of idiopathic pulmonary fibrosis (IPF), drug-induced pneumonitis, organizing pneumonia (including bronchiolitis obliterans organizing pneumonia), or idiopathic pneumonia;
- Receipt of live vaccines within 28 days before the first dose of study treatment;
- Any disease or condition that may contraindicate anticancer therapy, including but not limited to active infection, myocardial infarction within 6 months, symptomatic cardiac disease (including unstable angina, congestive heart failure, or uncontrolled arrhythmia), or ongoing immunosuppressive therapy;
- Pregnancy or breastfeeding; or male or female participants unwilling to use appropriate contraception when pregnancy is possible;
- Evidence of hereditary bleeding disorders or coagulation abnormalities;
- History of malignancy within the previous 3 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ with an expected survival of >3 years, such as breast cancer in situ, oral carcinoma in situ, or cervical carcinoma in situ;
- Any other medical history, disease, treatment, or laboratory abnormality that may interfere with study results, prevent full participation in the study, or make the participant unsuitable for enrollment as judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, 200433
Peng Zhang, PhD, zhangpeng1121@tongji.edu.cn
About this study
Official title: Effectiveness and Safety of MRG003 (Becotatug Vedotin) in Patients With Relapsed Small Cell Lung Cancer: A Single-Center, Single-Arm, Exploratory Study
This is a single-center, single-arm, exploratory clinical study evaluating the efficacy and safety of MRG003 (Becotatug Vedotin) in patients with relapsed small cell lung cancer. Eligible patients receive becotatug vedotin at a dose of 2.3 mg/kg administered by intravenous infusion once every 21 days until disease progression or unacceptable toxicity. The primary endpoint is overall survival (OS). Secondary endpoints include progression-free survival (PFS), objective response rate (ORR), and safety.
- Conditions
- Relapsed Small Cell Lung Cancer (SCLC)
- Being tested
- MRG003 (Becotatug Vedotin)
- 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.
MRG003 (Becotatug Vedotin)Drug
Participants receive becotatug vedotin 2.3 mg/kg by intravenous infusion once every 21 days (Q3W) until disease progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| MRG003 (Becotatug Vedotin) | Experimental | Becotatug vedotin 2.3 mg/kg is administered by intravenous infusion Q3W until disease progression or unacceptable toxicity. Receives: Drug: MRG003 (Becotatug Vedotin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Time from the date of first dose of study treatment to death from any cause.
Measured: up to 12 months
Secondary outcomes (2)
Objective Response Rate (ORR)
The proportion of patients with measurable disease at baseline who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST version 1.1.
Measured: up to 12 months
Progression-Free Survival (PFS)
Time from the date of first dose of study treatment to the first documented disease progression or death from any cause, whichever occurs first.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Oct 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Small Cell Lung Cancer (SCLC)Studies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Zhang, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Peng Zhang, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874581
- Sponsor's protocol ID
- LungMate-050
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of MRG003 (Becotatug Vedotin) in Patients With Relapsed Small Cell Lung Cancer: A Single-Center, Single-Arm, Exploratory Study
- ClinicalTrials.gov ID
- NCT07874581
- Acronym / sponsor ID
- LungMate-050
- Conditions
- Relapsed Small Cell Lung Cancer (SCLC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 15 Oct 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 is a single-center, single-arm, exploratory clinical study evaluating the efficacy and safety of MRG003 (Becotatug Vedotin) in patients with relapsed small cell lung cancer. Eligible patients receive becotatug vedotin at a dose of 2.3 mg/kg administered by intravenous infusion once every 21 days until disease progression or unacceptable toxicity. The primary endpoint is overall survival (OS). Secondary endpoints include progression-free survival (PFS), objective response rate (ORR), and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRG003 (Becotatug Vedotin) | Experimental | Drug: MRG003 (Becotatug Vedotin)Becotatug vedotin 2.3 mg/kg is administered by intravenous infusion Q3W until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent form (ICF);
- Age ≥18 years at the time of signing informed consent;
- Histologically confirmed small cell lung cancer (SCLC);
- Extensive-stage SCLC (ES-SCLC) with disease progression or recurrence after prior treatment;
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigator;
Key exclusion criteria (14 listed)
- Known hypersensitivity to becotatug vedotin;
- History of another active malignancy requiring treatment or history of allogeneic organ transplantation;
- Major surgery (excluding diagnostic biopsy) within 4 weeks before the first dose of study treatment;
- History of drug abuse, chronic alcohol abuse, AIDS, or HIV infection;
- Active autoimmune disease or history of autoimmune disease with potential risk of recurrence;
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 |
|---|---|---|
| MRG003 (Becotatug Vedotin)Participants receive becotatug vedotin 2.3 mg/kg by intravenous infusion once every 21 days (Q3W) until disease progression or unacceptable toxicity | Drug | MRG003 (Becotatug Vedotin) |
Primary outcome
Overall Survival (OS)
Time frame: up to 12 months
Time from the date of first dose of study treatment to death from any cause.
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: up to 12 months
Progression-Free Survival (PFS)
Time frame: up to 6 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 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Peng Zhang principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRG003 (Becotatug Vedotin) in people with Relapsed Small Cell Lung Cancer (SCLC), run by Shanghai Pulmonary Hospital, Shanghai, China 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 10 inclusion and 14 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 15 Oct 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.
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 Peng Zhang (02165115006, zhangpeng1121@tongji.edu.cn), 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 12 months). 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 15 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.