SCLC, Extensive StagePhase 1/2NCT07141771

An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing

A Phase 1/2 study testing Serplulimab, Fluzoparib and Topotecan/Irinotecan/Paclitaxel/Temozolomide in people with SCLC, Extensive Stage, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: SCLC, Extensive Stage
What is being tested?: Serplulimab, Fluzoparib and Topotecan/Irinotecan/Paclitaxel/Temozolomide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: No sites listed yet
Study dates: 31 Dec 2025to 31 Dec 2030
Phase: Phase 1/2
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

1. Be able to fully understand and sign the informed consent form, including compliance with the requirements and restrictions listed in the ICF and this protocol. A legally authorized representative may sign off on behalf of the subject.
2. Subject age must be 18 years (including 18 years). 3. Participants must have stage IV metastatic small cell lung cancer confirmed by histology or cytology, not suitable for radical surgery or radiotherapy, and have disease progression after first-line standard platinum-containing regimen.
4. The ECOG / WHO fitness status score is 0 to 1. 5. Expected survival time must be at least 12 weeks. 6. Participants agreed to perform the biopsy and could obtain enough tissue specimens for whole-exon sequencing, transcriptome sequencing, and multiplex fluorescent immunohistochemical detection.
7.The patient has sufficient important organ functions during screening (requiring no blood transfusion, no use of hematopoietic stimulating factors or human albumin preparations within 14 days prior to screening), and the specific definition is as follows:
Blood routine: Absolute neutrophil count (Absolute neutrophil count, ANC) 1.5109 / L; Platelet Count (Platelet, PLT)≥100×109/L; Hemoglobin content (Hemoglobin, HGB) 90 g / L;
liver function: serum total bilirubin (Total bilirubin, TBIL) 1.5 Upper Normal Value (Upper limit of normal value, ULN), Patients with liver metastasis or with proven Gilbert syndrome, TBIL≤3×ULN. For subjects without liver metastases, Alanine aminotransferase (Alanine aminotransferase, ALT) and aspartate aminotransferase (Aspartate transferase, AST) ≤2.5×ULN, Subjects with liver metastases, ALT or AST 5 ULN;

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Renal function: creatinine clearance calculated according to the Cockcroft-Gault method (Clearance of creatinine, CCr) 60 mL/min;
Coagulation: activated partial thromboplastin time (Activated partial thromboplastin time, APTT) and the international standardized ratio (International normalized ratio, INR) 1.5 ULN (subjects receiving anticoagulation are within treatment range);
cardiac function criteria: echocardiogram (Echocardiography, ECHO) showed a left ventricular ejection fraction (LVEF) greater than 50%.
8. The blood pregnancy test must be negative within 7 days before the first use of the test drug; fertile qualified patients (male and female) must agree to use reliable contraceptive methods (hormone or barrier method or abstinence) with their partner during the trial and at least 6 months after the last dose. Ferproductive patients were defined as sexually mature and with biologically underlying fertility.
9. Crias for molecular typing selection:
characteristics of transcription factor subtypes:
(1) SCLC-A and N types belong to neuroendocrine types, and SCLC-P and-I are cells with non-neuroendocrine subtypes. SCLC-A and N had significantly higher expression of neuroendocrine markers (chromaffin A (CgA) and synaptic vesicle protein (Syn)), while SCLC-P and I highly expressed the neuroendocrine inhibitory gene RE1 silent transcription factor (REST).
(2) SCLC-I is the most characteristic of stromal cells, while SCLC-A has the most characteristic of epithelial cells. High expression markers of SCLC-I of stromal cells: VIM and AXL. Most of the SCLC cells expressing the thyroid transcription factor (TTF 1) belong to the SCLC-A type.
(3) The vast majority of TP 53 and RB 1 mutations do not differ in subtype classification, and the classification of subtypes is not associated with specific gene mutations.
In conclusion, SCLC-A is neuroendocrine with epithelial cells, expressing TTF 1; SCLC-N, also neuroendocrine, but not TTF 1; SCLC-P and SCLC-I are non-neuroendocrine, while SCLC-I has a subtype characterized by mesenchymal cells.
H-score method (integral system): IHC test of tissue specimens to calculate the product of the percentage of positive tumor cell nuclear staining (0-100%) observed under the optical microscope and its staining intensity (intensity, 0,1 +, 2 +, 3 +), to obtain H-score (range 0-300) 13.
SLFN11:1 + under IHC score is positive 13, and the cut-off value is usually selected 10,10, which is defined as high expression 28.
BCL-2: The average copy number per spot was calculated based on the minimum and maximum number of Bcl-2 FISH signal from each nucleus in each tissue site. Copy arrays were constructed based on the absolute gene copy number using the following criteria: 1 to 2 signals with average copy number <2.5; 3 to 4 signals, average copy number 2.5 and <4.5; 5 to 6 signals, average copy number 4.5 and <6.5; and 7 to 10 signals, with average copy number 6.5 29.
c-Myc: IHC 1 +, 2 + and 3 + were positive; 0 was negative.
If two or more markers in the same class have an H score of more than 10, then multiple markers in the tumor may be positive. The predominant marker was defined as the marker with the highest H-Score.
TROP-2: IHC stains at least 10% of tumor cells with an intensity score of 1 + (weak), and 2 + (moderate) and 3 + (strong) are defined as positive 22. At the same time, ANPY will be tested simultaneously (before the start of treatment) and submitted for transcriptomic testing.
10, with at least 1 measurable lesion according to RECIST 1.1.

Who cannot join

Acute toxicity associated with prior anti-tumor therapy for 4 weeks prior to the first dose did not return to grade NCI CTCAE v5.0 1 or the baseline level specified by the entry criteria (excluding alopecia or fatigue).
The following drugs or herbal supplements cannot be stopped within 3 weeks before and during the study: (1) strong inducers or inhibitors of CYP3A4; (2) drugs mainly metabolized by CYP3A4;
The subject does not agree to secondary biopsy or cannot obtain enough tissue specimens for full exon sequencing, transcriptome sequencing, and multiple fluorescent immunohistochemical testing.
Mean corrected QT interval (Corrected QT interval, QTc, Fridericia's correction) from 12-lead ECG (12-Electrocardiograph, ECG)> 470 ms (3 repeats). Various clinically significant cardiac rhythm, conduction, and resting ECG morphology abnormalities, such as complete left bundle branch block, degree III conduction block, degree II conduction block, and PR interval> 250 ms. Various factors that may increase the risk of QTc extension or arrhythmic events, such as cardiac failure, hypokalemia, congenital long QT syndrome, long QT syndrome in immediate family history or unexplained sudden death under 40 years of age, are using any medication with known QT interval extension.
Acute or chronic active hepatitis B [defined as hepatitis B surface antigen (HbsAg) and/or hepatitis B core antibody (HbcAb) positive and hepatitis B virus (HBV) DNA copy number ≥ 1 × 10]3 copies per mL or ≥ 200 IU/mL.
Acute or chronic active hepatitis C (HCV), or HCV antibody positive and HCV-RNA levels greater than the upper central reference limit.

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7 Patients with active brain metastases are enrolled if their central nervous system (Central nervous system, CNS) tumor metastasis is limited to supratentorial or cerebellum, is adequately treated (surgery or radiotherapy), has maintained radiographic stability for at least 4 weeks, and does not require corticosteroids to control symptoms.
8 Concurrent diseases failing to control, Example: a) severe infection occurred within 4 weeks before initiation of study treatment, Including but not limited to hospitalization for infection, bacteremia or complications of severe pneumonia; Or having received therapeutic oral or intravenous antibiotics within two weeks prior to starting study treatment, Patients receiving prophylactic antibiotic therapy may be enrolled (e. g. prevention of urinary tract infection or chronic obstructive pulmonary disease); b) symptomatic congestive heart failure (New York Heart Association Grade II-IV) or symptomatic or poorly controlled arrhythmia; c) with other malignancies within 5 years prior to treatment (cutaneous carcinoma, breast / cervix, and in situ, nonmelanoma with radical treatment and no evidence of disease recurrence); And d) suspected or confirmed subjects with acute promyelocytic leukemia (indicated by morphology, immunotyping, molecular testing, or chromosome karyotype); e) subjects with current cancerous meningitis, spinal cord compression, etc.; f) a history of poorly controlled hypertension and diabetes; g) symptomatic endogenous lung disease; h) any arterial thromboembolic event within 6 months prior to inclusion, Including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack; i) significant malnutrition, If intravenous nutrition solution is needed. Stable for more than 4 weeks after correction of malnutrition before the first dose of study drug can be enrolled; j) tumor invasion of important surrounding organs or blood vessels (such as mediastinal macrovessels, superior vena cava, trachea, esophagus, etc.), Or at risk of oesophageal tracheal fistula or oesophageal pleural fistula; k) after esophageal or endotracheal cavity stenting; l) other acute or chronic diseases or abnormal laboratory test values that may lead to the following results: increase the risk associated with study participation or study drug administration, Or to interfere with the interpretation of the study findings, And listed the subject as ineligible for the study at the discretion of the investigator; m) a history of gastrointestinal perforation and / or fistula within 6 months prior to study inclusion. N) with an uncontrolled third-space effusion requiring repeated drainage, such as pleural fluid, ascites, and pericardial effusion.(Patients who do not require drainage or have no significant increase for 3 days can be enrolled).
9. Patients with active gastrointestinal or other diseases, as well as factors such as surgical resection that may significantly affect drug absorption, metabolism, or excretion. Including but not limited to the following situations: malabsorption syndrome, inflammatory bowel disease, partial or complete intestinal obstruction, gastric or small intestine resection surgery.
10. Patients had a history of severe underlying pulmonary disease or medical conditions, such as moderate to severe chronic obstructive pulmonary disease (COPD), interstitial pulmonary disease (ILD), drug-induced ILD, acute or chronic infectious pneumonia, lung transplantation, etc.; 11. Pregnant or lactating women. 12 is participating in another interventional clinical study and has not completed study treatment.
13 A known history of allogeneic organ transplantation and allogeneic HSCT. 14. Major surgical procedure (craniotomy, thoracotomy, laparotomy, vascular intervention, otherwise defined by the investigator) within 4 weeks of the first administration of the study drug, or the presence of an unhealed wound, ulcer, or fracture. Note: Local surgical treatment of isolated lesions is acceptable for the purpose of palliative treatment.
15. HIV-infected persons (HIV 1 / 2 antibody-positive). 16 Known active syphilis infection, active pulmonary tuberculosis. 17 Patients with a clear history of mental disorders and medication for treatment.
18. People with a history of drug abuse or drug use. 19. The investigator considers that the patient has other factors that may affect the study results and interfere with the entire study process, including previous, or existing physical conditions, treatment or laboratory abnormalities, and the subject's unwillingness to comply with the procedures, limitations and requirements of the study.

About this study

Small-cell lung cancer (SCLC) has a high degree of malignancy and extremely poor prognosis, slow progress in the treatment of ES-SCLC, and a more ideal posterior therapy needs to be explored. This is an I / II, phase umbrella study to explore afterline treatment options following progression of frontline platinum-containing therapy for small cell lung cancer.

This study includes 2 parts:

Part 1 will enroll patients with end of first-line platinum-containing therapy and progression interval of less than 180 days or more of second-line therapy (no first-line relapse time required).

Part 2 will enroll patients with end of first-line platinum-containing therapy greater than 180 days.

Based on the optimal selection of patients with recurrent broad-stage small cell lung cancer with different molecular and clinical characteristics, we further explored different treatment modes suitable for different populations through umbrella cohort studies.

Read the detailed description

This study includes 2 parts:

Part 1 will enroll patients with end of first-line platinum-containing therapy and progression interval of less than 180 days or more of second-line therapy (no first-line relapse time required).

Cohort 1 patients enrolled with N subtype were given either Serplulimab plus second-line chemotherapy or other treatment as assessed by the physician; cohort 2 patients enrolled with subtype P and subtype A with low BCL-2 expression were given Fluzoparib with Temozolomide ; cohort 3 patients enrolled with subtype Y received Serplulimab plus second-line chemotherapy ;

Part 2 will enroll patients with end of first-line platinum-containing therapy greater than 180 days.

Cohort 4 patients with low expression in SLFN11 were given Serplulimab plus first-line chemotherapy ; cohort 5 patients with high SLFN11 expression were given Serplulimab plus Lurbinectedin.

Conditions: SCLC, Extensive Stage
Being tested: Serplulimab, Fluzoparib, Topotecan/Irinotecan/Paclitaxel/Temozolomide, Etoposide/Carboplatin/Cisplatin, Lurbinectedin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SerplulimabDrug
Also called HLX10, Hetronifly
Serplulimab: 4.5mg/kg, ivgtt, 21 days/cycle
FluzoparibDrug
Also called HS-10160, HR011417, SHR3162, SHR133162
100mg BID oral
Topotecan/Irinotecan/Paclitaxel/TemozolomideDrug
second-line chemotherapy options: Topotecan/Irinotecan/Paclitaxel/Temozolomide etc.
Etoposide/Carboplatin/CisplatinDrug
First-line chemotherapy: the original first-line chemotherapy regimen, recommended Etoposide 100mg / m2 d1-3, Carboplatin AUC = 5 d1 / Cisplatin 75mg / m2 d1 q21d
LurbinectedinDrug
Also called PM01183, Zepzelca
2.6mg/m2 (3 patients, if safe, in the 3.2mg / m2 dose group) or 3.2 mg / m2, ivgttd,21d / cycle .
TemozolomideDrug
150mg/m2, oral, on days 1-5,28d / cycle

Study groups in NCT07141771
Study group	Role	What they receive
N subtype	Experimental	N subtype Receives: Drug: Serplulimab; Drug: Topotecan/Irinotecan/Paclitaxel/Temozolomide
subtype P and subtype A with low BCL-2 expression	Experimental	subtype P and subtype A with low BCL-2 expression Receives: Drug: Fluzoparib; Drug: Temozolomide
subtype Y	Experimental	subtype Y Receives: Drug: Serplulimab; Drug: Topotecan/Irinotecan/Paclitaxel/Temozolomide
low expression in SLFN11	Experimental	low expression in SLFN11 Receives: Drug: Serplulimab; Drug: Etoposide/Carboplatin/Cisplatin
high expression in SLFN11	Experimental	high expression in SLFN11 Receives: Drug: Serplulimab; Drug: Lurbinectedin

What is being measured

The primary outcome is the main question the study is designed to answer.

ORR
ORR based on molecular subtyping of small cell lung cancer
Measured: each cycle is 21 or28 days,from the first use until the date of first documented progression or date of death from any cause or start new anti-tumor therapy or withdraw ICF or the study is over，whichever came first, assessed up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Dec 202531 Dec 2030

First posted26 Aug 2025
Study start31 Dec 2025 (estimated)
Primary completion30 Jun 2030 (estimated)
Study completion31 Dec 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 Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07141771
Sponsor's protocol ID: UM-SCLC
Status last verified: Jul 2025
First submitted: 31 Jul 2025
Last updated: 26 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 3
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
Extensive-Stage Small-Cell Lung Cancer, Small-Cell Lung Cancer
RecruitingPhase 2
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Extensive-stage Small-cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
RecruitingPhase 2
MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer
Small Cell Lung Cancer, SCLC
Not yet recruitingPhase 2
Low-Dose Radiotherapy Plus Adebrelimab and Chemotherapy for Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage

All SCLC, Extensive Stage trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing
ClinicalTrials.gov ID: NCT07141771
Acronym / sponsor ID: UM-SCLC
Conditions: SCLC, Extensive Stage
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
Study start: 31 Dec 2025 (estimated)
Primary completion: 30 Jun 2030 (estimated)
Study completion: 31 Dec 2030 (estimated)
First posted: 26 Aug 2025 (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 includes 2 parts:

Part 1 will enroll patients with end of first-line platinum-containing therapy and progression interval of less than 180 days or more of second-line therapy (no first-line relapse time required).

Part 2 will enroll patients with end of first-line platinum-containing therapy greater than 180 days.

Detailed description

This study includes 2 parts:

Part 1 will enroll patients with end of first-line platinum-containing therapy and progression interval of less than 180 days or more of second-line therapy (no first-line relapse time required).

Part 2 will enroll patients with end of first-line platinum-containing therapy greater than 180 days.

Cohort 4 patients with low expression in SLFN11 were given Serplulimab plus first-line chemotherapy ; cohort 5 patients with high SLFN11 expression were given Serplulimab plus Lurbinectedin.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
N subtype	Experimental	Drug: Serplulimab, Drug: Topotecan/Irinotecan/Paclitaxel/TemozolomideN subtype
subtype P and subtype A with low BCL-2 expression	Experimental	Drug: Fluzoparib, Drug: Temozolomidesubtype P and subtype A with low BCL-2 expression
subtype Y	Experimental	Drug: Serplulimab, Drug: Topotecan/Irinotecan/Paclitaxel/Temozolomidesubtype Y
low expression in SLFN11	Experimental	Drug: Serplulimab, Drug: Etoposide/Carboplatin/Cisplatinlow expression in SLFN11
high expression in SLFN11	Experimental	Drug: Serplulimab, Drug: Lurbinectedinhigh expression in SLFN11

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

1. Be able to fully understand and sign the informed consent form, including compliance with the requirements and restrictions listed in the ICF and this protocol. A legally authorized representative may sign off on behalf of the subject.
2. Subject age must be 18 years (including 18 years). 3. Participants must have stage IV metastatic small cell lung cancer confirmed by histology or cytology, not suitable for radical surgery or radiotherapy, and have disease progression after first-line standard platinum-containing regimen.
4. The ECOG / WHO fitness status score is 0 to 1. 5. Expected survival time must be at least 12 weeks. 6. Participants agreed to perform the biopsy and could obtain enough tissue specimens for whole-exon sequencing, transcriptome sequencing, and multiplex fluorescent immunohistochemical detection.
7.The patient has sufficient important organ functions during screening (requiring no blood transfusion, no use of hematopoietic stimulating factors or human albumin preparations within 14 days prior to screening), and the specific definition is as follows:
Blood routine: Absolute neutrophil count (Absolute neutrophil count, ANC) 1.5109 / L; Platelet Count (Platelet, PLT)≥100×109/L; Hemoglobin content (Hemoglobin, HGB) 90 g / L;

Key exclusion criteria (13 listed)

7 Patients with active brain metastases are enrolled if their central nervous system (Central nervous system, CNS) tumor metastasis is limited to supratentorial or cerebellum, is adequately treated (surgery or radiotherapy), has maintained radiographic stability for at least 4 weeks, and does not require corticosteroids to control symptoms.
8 Concurrent diseases failing to control, Example: a) severe infection occurred within 4 weeks before initiation of study treatment, Including but not limited to hospitalization for infection, bacteremia or complications of severe pneumonia; Or having received therapeutic oral or intravenous antibiotics within two weeks prior to starting study treatment, Patients receiving prophylactic antibiotic therapy may be enrolled (e. g. prevention of urinary tract infection or chronic obstructive pulmonary disease); b) symptomatic congestive heart failure (New York Heart Association Grade II-IV) or symptomatic or poorly controlled arrhythmia; c) with other malignancies within 5 years prior to treatment (cutaneous carcinoma, breast / cervix, and in situ, nonmelanoma with radical treatment and no evidence of disease recurrence); And d) suspected or confirmed subjects with acute promyelocytic leukemia (indicated by morphology, immunotyping, molecular testing, or chromosome karyotype); e) subjects with current cancerous meningitis, spinal cord compression, etc.; f) a history of poorly controlled hypertension and diabetes; g) symptomatic endogenous lung disease; h) any arterial thromboembolic event within 6 months prior to inclusion, Including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack; i) significant malnutrition, If intravenous nutrition solution is needed. Stable for more than 4 weeks after correction of malnutrition before the first dose of study drug can be enrolled; j) tumor invasion of important surrounding organs or blood vessels (such as mediastinal macrovessels, superior vena cava, trachea, esophagus, etc.), Or at risk of oesophageal tracheal fistula or oesophageal pleural fistula; k) after esophageal or endotracheal cavity stenting; l) other acute or chronic diseases or abnormal laboratory test values that may lead to the following results: increase the risk associated with study participation or study drug administration, Or to interfere with the interpretation of the study findings, And listed the subject as ineligible for the study at the discretion of the investigator; m) a history of gastrointestinal perforation and / or fistula within 6 months prior to study inclusion. N) with an uncontrolled third-space effusion requiring repeated drainage, such as pleural fluid, ascites, and pericardial effusion.(Patients who do not require drainage or have no significant increase for 3 days can be enrolled).
9. Patients with active gastrointestinal or other diseases, as well as factors such as surgical resection that may significantly affect drug absorption, metabolism, or excretion. Including but not limited to the following situations: malabsorption syndrome, inflammatory bowel disease, partial or complete intestinal obstruction, gastric or small intestine resection surgery.
10. Patients had a history of severe underlying pulmonary disease or medical conditions, such as moderate to severe chronic obstructive pulmonary disease (COPD), interstitial pulmonary disease (ILD), drug-induced ILD, acute or chronic infectious pneumonia, lung transplantation, etc.; 11. Pregnant or lactating women. 12 is participating in another interventional clinical study and has not completed study treatment.
13 A known history of allogeneic organ transplantation and allogeneic HSCT. 14. Major surgical procedure (craniotomy, thoracotomy, laparotomy, vascular intervention, otherwise defined by the investigator) within 4 weeks of the first administration of the study drug, or the presence of an unhealed wound, ulcer, or fracture. Note: Local surgical treatment of isolated lesions is acceptable for the purpose of palliative treatment.

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
SerplulimabAlso: HLX10, HetroniflySerplulimab: 4.5mg/kg, ivgtt, 21 days/cycle	Drug	N subtype, high expression in SLFN11, low expression in SLFN11, subtype Y
FluzoparibAlso: HS-10160, HR011417, SHR3162, SHR133162100mg BID oral	Drug	subtype P and subtype A with low BCL-2 expression
Topotecan/Irinotecan/Paclitaxel/Temozolomidesecond-line chemotherapy options: Topotecan/Irinotecan/Paclitaxel/Temozolomide etc.	Drug	N subtype, subtype Y
Etoposide/Carboplatin/CisplatinFirst-line chemotherapy: the original first-line chemotherapy regimen, recommended Etoposide 100mg / m2 d1-3, Carboplatin AUC = 5 d1 / Cisplatin 75mg / m2 d1 q21d	Drug	low expression in SLFN11
LurbinectedinAlso: PM01183, Zepzelca2.6mg/m2 (3 patients, if safe, in the 3.2mg / m2 dose group) or 3.2 mg / m2, ivgttd,21d / cycle .	Drug	high expression in SLFN11
Temozolomide150mg/m2, oral, on days 1-5,28d / cycle	Drug	subtype P and subtype A with low BCL-2 expression

Primary outcome

ORR
Time frame: each cycle is 21 or28 days,from the first use until the date of first documented progression or date of death from any cause or start new anti-tumor therapy or withdraw ICF or the study is over，whichever came first, assessed up to 24 months
ORR based on molecular subtyping of small cell lung cancer

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 26 Aug 2025.
Individual participant dataSharing planned: No

Related trials for SCLC, Extensive Stage

Active, not recruitingPhase 3
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
Extensive-Stage Small-Cell Lung Cancer, Small-Cell Lung Cancer
RecruitingPhase 2
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Extensive-stage Small-cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
RecruitingPhase 2
MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer
Small Cell Lung Cancer, SCLC
Not yet recruitingPhase 2
Low-Dose Radiotherapy Plus Adebrelimab and Chemotherapy for Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

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 23 inclusion and 13 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: opening soon, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

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?

ORR (time frame: each cycle is 21 or28 days,from the first use until the date of first documented progression or date of death from any cause or start new anti-tumor therapy or withdraw ICF or the study is over，whichever came first, assessed up to 24 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 NCT07141771.

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 26 Aug 2025.