Extensive-Stage Small Cell Lung CancerPhase 2NCT06497530
Maintenance Lurbinectedin in Combination With Serplulimab for Patients With ES-SCLC
A Phase 2 study testing Serplulimab, Lurbinectedin and Carboplatin in people with Extensive-Stage Small Cell Lung Cancer, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
This is a single-arm, open-lable exploratory study of Lurbinectedin in combination with Serplulimab as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and Serplulimab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-Stage Small Cell Lung Cancer
- What is being tested?
- Serplulimab, Lurbinectedin and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to Dec 2026
- Phase
- Phase 2
- 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
- Fully informed about the study and voluntarily signed a written informed consent form, and able to comply with the requirements and restrictions listed in the informed consent form;
- Male or female with age ≥ 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1;
- Histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) and has not received any systemic treatment for ES-SCLC;
- At least one measurable lesion (according to RECIST 1.1 criteria);
- Having adequate bone marrow, hepatic, renal and metabolic function, meaning the functional level of the organs meets the following requirements:
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- Platelet count (PLT) ≥ 100×10^9/L; Hemoglobin (Hb) ≥ 90 g/L; Absolute neutrophil count (ANC) ≥ 2.0×10^9/L;
- Regardless of whether liver metastasis is present, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0×upper limit of normal (ULN);
- Alkaline phosphatase (ALP) ≤ 5×ULN;
- Total bilirubin (TBIL) ≤ 1.5×ULN, and direct bilirubin ≤ 1.0×ULN;
- Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 30 mL/min (calculated using the Cockcroft-Gault formula);
- Creatine phosphokinase (CPK) ≤ 2.5×ULN;
- Albumin ≥ 3.0 g/dL.
- Women of childbearing potential(WOCBP) must have a negative serum pregnancy test before enrollment. WOCBP must use effective contraceptive measure during the trial drug treatment and for 6 months after the last administration. Male patients (with partners of WOCBP) must use effective contraceptive measure during the trial drug treatment and for 4 months after the last administration;
- Human immunodeficiency virus (HIV)-negative, with no active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Have a continuous response or stable disease according to RECIST 1.1 criteria after 4 cycles of induction therapy;
- Toxicity from the induction therapy phase has recovered to ≤ Grade 1;
- Have sufficient bone marrow and organ function.
Who cannot join
- Have a history of central nervous system (CNS) metastasis or related history;
- Have a history of active autoimmune disease or immunodeficiency, or related history;
- Have a history of malignancies other than SCLC within 5 years before enrollment;
- Previous treatment with immune checkpoint inhibitors or lurbinectedin;
- Have a history of idiopathic pulmonary fibrosis or pneumonia, or active pneumonia detected in CT screening;
- Treatment with any other investigational product within 28 days before enrollment.
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- Have a history of central nervous system (CNS) metastasis or related history;
- Has received chest consolidation radiotherapy;
- Severe infection within 2 weeks before enrollment.
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
The first affiliated hospital of Guangzhou medical university
Guangzhou, Guangdong, 51000
Liu, Doctor, 020-81566477, mingliu128@hotmail.com
About this study
Official title: An Exploratory Study of Maintenance Lurbinectedin in Combination With Serplulimab for Patients With Extensive-Stage Small Cell Lung Cancer
This is a single-arm, open-lable exploratory study of Lurbinectedin in combination with Serplulimab as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and Serplulimab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and Serplulimab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will receive lurbinectedin plus Serplulimab in the maintenance phase.
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Being tested
- Serplulimab, Lurbinectedin, Carboplatin, Etoposide
- 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.
SerplulimabDrug
Serplulimab will be administered intravenously at a dose of 4.5 mg/kg on Day 1 of each 21-day cycle for 4 cycles in the induction phase.
Serplulimab will be administered intravenously at a dose of 4.5 mg/kg on Day 1 of each 21-day cycle in the maintenance phase.
LurbinectedinDrug
Also called PM01183
Lurbinectedin will be administered intravenously at a fixed dose of 4 mg on Day 1 of each 21-day cycle in the maintenance phase.
CarboplatinDrug
Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.
EtoposideDrug
Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment | Experimental | Induction phase：participants will receive Serplulimab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles.
Maintenance phase：participants will receive Serplulimab on Day 1 of each 21-day cycle in combination with Lurbinectedin on Day 1 of each 21-day cycle. Receives: Drug: Serplulimab; Drug: Lurbinectedin; Drug: Carboplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
progression-free survival (PFS) is defined as the time from the initiation of maintenance therapy to the date of first documented disease progression (as assessed according to RECIST v1.1) or death whichever occurs first.
Measured: Initiation of maintenance therapy to the date of first documented disease progression or death whichever occurs first (up to approximately 24 months)
Secondary outcomes (4)
Overall Survival (OS)
Overall survival (OS) is defined as the time from the initiation of maintenance therapy to the date of death from any cause.
Measured: Initiation of maintenance therapy to the date of death from any cause (up to approximately 24 months)
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants with a complete response（CR） or partial response（PR） according to RECIST v1.1.
Measured: up to approximately 24 months
Duration of Response (DOR)
Duration of Response (DOR) (for participants with a confirmed objective response) is defined as the time from the first occurrence of a documented confirmed objective response until disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.
Measured: up to approximately 24 months
Percentage of Participants With Adverse Events
Percentage of participants with adverse events
Measured: up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
- Investigators
- chengzhi Zhou, MD, Principal investigator, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497530
- Sponsor's protocol ID
- CROC-24-02
- Status last verified
- Jun 2026
- First submitted
- 5 Jul 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Maintenance Lurbinectedin in Combination With Serplulimab for Patients With Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06497530
- Acronym / sponsor ID
- CROC-24-02
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Jul 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 is a single-arm, open-lable exploratory study of Lurbinectedin in combination with Serplulimab as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and Serplulimab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and Serplulimab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will receive lurbinectedin plus Serplulimab in the maintenance phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment | Experimental | Drug: Serplulimab, Drug: Lurbinectedin, Drug: Carboplatin, Drug: EtoposideInduction phase：participants will receive Serplulimab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase：participants will receive Serplulimab on Day 1 of each 21-day cycle in combination with Lurbinectedin on Day 1 of each 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Fully informed about the study and voluntarily signed a written informed consent form, and able to comply with the requirements and restrictions listed in the informed consent form;
- Male or female with age ≥ 18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1;
- Histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) and has not received any systemic treatment for ES-SCLC;
- At least one measurable lesion (according to RECIST 1.1 criteria);
Key exclusion criteria (9 listed)
- Have a history of central nervous system (CNS) metastasis or related history;
- Have a history of active autoimmune disease or immunodeficiency, or related history;
- Have a history of malignancies other than SCLC within 5 years before enrollment;
- Previous treatment with immune checkpoint inhibitors or lurbinectedin;
- Have a history of idiopathic pulmonary fibrosis or pneumonia, or active pneumonia detected in CT screening;
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 |
|---|---|---|
| SerplulimabSerplulimab will be administered intravenously at a dose of 4.5 mg/kg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Serplulimab will be administered intravenously at a dose of 4.5 mg/kg on Day 1 of each 21-day cycle in the maintenance phase. | Drug | Experimental Treatment |
| LurbinectedinAlso: PM01183Lurbinectedin will be administered intravenously at a fixed dose of 4 mg on Day 1 of each 21-day cycle in the maintenance phase. | Drug | Experimental Treatment |
| CarboplatinCarboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase. | Drug | Experimental Treatment |
| EtoposideEtoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase. | Drug | Experimental Treatment |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Initiation of maintenance therapy to the date of first documented disease progression or death whichever occurs first (up to approximately 24 months)
progression-free survival (PFS) is defined as the time from the initiation of maintenance therapy to the date of first documented disease progression (as assessed according to RECIST v1.1) or death whichever occurs first.
4 secondary outcomes
Overall Survival (OS)
Time frame: Initiation of maintenance therapy to the date of death from any cause (up to approximately 24 months)
Objective Response Rate (ORR)
Time frame: up to approximately 24 months
Duration of Response (DOR)
Time frame: up to approximately 24 months
Percentage of Participants With Adverse Events
Time frame: up to approximately 24 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 8 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared
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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.
chengzhi Zhou, MD principal investigator
Guangzhou Institute of Respiratory Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serplulimab, Lurbinectedin and Carboplatin in people with Extensive-Stage Small Cell Lung Cancer, run by Guangzhou Institute of Respiratory Disease 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 18 inclusion and 9 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 8 Jun 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Ming Liu, MD (+0086 186 8838 0929, mingliu128@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Initiation of maintenance therapy to the date of first documented disease progression or death whichever occurs first (up to approximately 24 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 8 Jun 2026.