SCLC, Extensive StagePhase 2Aurora 005NCT07538271
A Study of Benmelstobart, Anlotinib, Chemotherapy and Thoracic Radiotherapy for People With Extensive-stage Small Cell Lung Cancer
A Phase 2 study testing benmelstobart, Anlotinib and Carboplatin or cisplatin in people with SCLC, Extensive Stage, run by Yayi He.
Trial summary
This is a single-center, single-arm, exploratory clinical study conducted at Shanghai Pulmonary Hospital, Tongji University. It aims to evaluate the efficacy and safety of first-line treatment with benmelstobart plus anlotinib and chemotherapy (carboplatin/cisplatin plus etoposide), followed by sequential thoracic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SCLC, Extensive Stage
- What is being tested?
- benmelstobart, Anlotinib and Carboplatin or cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 31 Mar 2029
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1: Histologically or cytologically confirmed inoperable extensive-stage small cell lung cancer (ES-SCLC) according to the VALG staging system
- 2: No prior systemic therapy for extensive-stage small cell lung cancer (ES-SCLC)
- 3: Presence of measurable lesions as defined by the RECIST 1.1 criteria. A previously irradiated lesion can be considered measurable only if there is clear progression after radiotherapy and it is not the sole lesion
- 4: Aged 18 to 75 years
- 5: ECOG performance status score of 0 to 1
- 6: Expected survival time ≥ 3 months
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- 7: Number of tumor metastases ≤ 3. Brain metastases must be asymptomatic or treated and stable for at least 1 month prior to the initiation of study treatment, with no use of steroids or anticonvulsants during this period
- 8: Adequate hematological and organ function, meeting the following criteria: a) Hematology (no blood transfusion or blood products within 14 days; no correction with G-CSF or other hematopoietic stimulants): i. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L (1,500/mm³); ii. Platelet Count (PLT) ≥ 100 × 10⁹/L (100,000/mm³); iii. Hemoglobin (HB) ≥ 80 g/L. b) Renal function: i. Calculated Creatinine Clearance Rate (CrCl) ≥ 50 mL/min; ii. Urine protein < 2+ or 24-hour urinary protein quantitation < 1.0 g. c) Hepatic function: i. Serum Total Bilirubin (TBil) ≤ 1.5 × ULN (for patients with liver metastases, TBil ≤ 3 × ULN); ii. AST and ALT ≤ 2.5 × ULN (for patients with liver metastases, ≤ 5 × ULN); iii. Serum Albumin (ALB) ≥ 28 g/L. d) Coagulation function: i. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN. e) Cardiac function: i. Left Ventricular Ejection Fraction (LVEF) ≥ 50%. f) Other: i. Lipase ≤ 1.5 × ULN; patients with lipase > 1.5 × ULN may be enrolled if there is no clinical or radiological evidence of pancreatitis; ii. Amylase ≤ 1.5 × ULN; patients with amylase > 1.5 × ULN may be enrolled if there is no clinical or radiological evidence of pancreatitis; iii. Alkaline Phosphatase (ALP) ≤ 2.5 × ULN (for patients with bone metastases, ALP ≤ 5 × ULN
- 9: The subject voluntarily agrees to participate in the study, signs the informed consent form, has good compliance, and is willing to cooperate with follow-up
Who cannot join
- 1: Patients with symptomatic brain metastases. Patients whose brain metastases have been treated and remain clinically stable for at least 1 month, with no use of steroids or anticonvulsants for at least 1 month prior to study enrollment, are eligible
- 2: Prior use of anti-angiogenic agents such as anlotinib, apatinib, bevacizumab, or immune checkpoint inhibitors targeting PD-1, PD-L1, etc
- 3: Patients with conditions that affect oral drug administration (e.g., dysphagia, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.)
- 4: Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- 5: Patients with radiological evidence of tumor invasion around major blood vessels, or those judged by the investigator to be at high risk of fatal massive hemorrhage due to potential tumor invasion of major blood vessels during the study
- 6: History of severe bleeding tendency or coagulation disorders, including but not limited to: clinically significant hemoptysis (≥ 1 tablespoon per day) within 3 months prior to enrollment; or clinically significant bleeding symptoms or tendency within 4 weeks prior to group assignment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer (including gastrointestinal perforation and/or fistula; patients with gastrointestinal perforation or fistula that has been surgically resected are eligible), unhealed wounds, ulcers, or fractures, etc
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- 7: Receipt of major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to group assignment
- 8: History of arterial/venous thrombotic events (e.g., cerebrovascular accident including transient ischemic attack, deep vein thrombosis, pulmonary embolism) within 6 months prior to group assignment
- 9: Active autoimmune disease requiring systemic treatment (e.g., disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose of study drug
- 10: Other conditions that increase the risk associated with study participation or study drugs and, in the investigator's judgment, render the patient unsuitable for enrollment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-arm, Exploratory Clinical Study of Benmelstobart Combined With Anlotinib and Chemotherapy Followed by Thoracic Radiotherapy as First-line Treatment for Extensive-stage Small Cell Lung Cancer (ES-SCLC)
This is a single-center, single-arm, exploratory clinical study conducted at Shanghai Pulmonary Hospital, Tongji University. It aims to evaluate the efficacy and safety of first-line treatment with benmelstobart plus anlotinib and chemotherapy (carboplatin/cisplatin plus etoposide), followed by sequential thoracic radiotherapy, in patients with previously untreated extensive-stage small cell lung cancer (ES-SCLC).
Eligible participants will be adults aged 18-75 years with histologically or cytologically confirmed ES-SCLC, measurable lesions per RECIST 1.1, ECOG performance status 0-1, and adequate organ function. Patients will receive 4 cycles of induction therapy (benmelstobart, anlotinib, platinum-etoposide chemotherapy). Those without disease progression will receive consolidative thoracic radiotherapy, followed by maintenance therapy with benmelstobart plus anlotinib until disease progression or unacceptable toxicity.
The primary endpoint is objective response rate (ORR) assessed by investigators. Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety parameters including adverse events graded by CTCAE 5.0. A total of 33 subjects will be enrolled. This study uses a non-randomized, open-label design without a control group.
Read the detailed description
This is a single-center, single-arm, prospective, exploratory clinical trial to evaluate the efficacy and safety of first-line benmelstobart combined with anlotinib and platinum-etoposide chemotherapy, followed by sequential thoracic radiotherapy, in patients with untreated extensive-stage small cell lung cancer (ES-SCLC).
Eligible patients will receive 4 cycles of 21-day induction therapy consisting of intravenous benmelstobart 1200 mg on day 1, oral anlotinib 12 mg once daily for 2 weeks on / 1 week off, plus carboplatin (AUC 5) or cisplatin (75-80 mg/m²) on day 1 and etoposide 100 mg/m² on days 1-3 of each cycle. Patients without disease progression after induction therapy will receive consolidative thoracic radiotherapy (2 Gy per fraction, 25-30 fractions). Maintenance therapy with benmelstobart plus anlotinib will be administered until disease progression, unacceptable toxicity, or a maximum of 2 years.
The primary outcome is investigator-assessed objective response rate (ORR) per RECIST 1.1. Secondary outcomes include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety assessed by adverse events (AE, SAE, irAE) graded according to CTCAE version 5.0. A total of 33 subjects will be enrolled.
- Conditions
- SCLC, Extensive Stage
- Keywords
- Small Cell Lung Cancer, Extensive-Stage, Benmelstobart, Anlotinib, Chemotherapy, Thoracic Radiotherapy, First-Line
- 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.
benmelstobartDrug
A PD-L1 inhibitor (biological product) administered intravenously. Used for immunotherapy in combination with other agents to treat extensive-stage small cell lung cancer (ES-SCLC).
AnlotinibDrug
A small-molecule anti-angiogenic drug administered orally. Inhibits tumor angiogenesis to suppress tumor growth, used as part of the first-line combined therapy for ES-SCLC.
Carboplatin or cisplatinDrug
A platinum-based chemotherapeutic agent administered intravenously.
EtoposideDrug
A topoisomerase II inhibitor administered intravenously. Works by interfering with tumor cell replication, combined with platinum agents as first-line chemotherapy for ES-SCLC.
Thoracic RadiotherapyRadiation
External beam radiation therapy delivered to the thoracic region. Administered as consolidative treatment for non-progressive ES-SCLC patients after induction therapy, with a total dose based on clinical practice guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Benmelstobart + Anlotinib + Chemotherapy Followed by Thoracic Radiotherapy | Experimental | Eligible patients receive 4 cycles of induction therapy (benmelstobart 1200mg IV D1 + anlotinib 12mg PO QD 2w-on/1w-off + carboplatin/cisplatin + etoposide). Non-progressive patients proceed to consolidative thoracic radiotherapy (2Gy/fraction, 25-30 fractions), followed by maintenance therapy with benmelstobart + anlotinib until disease progression or unacceptable toxicity. Receives: Drug: benmelstobart; Drug: Anlotinib; Drug: Carboplatin or cisplatin; Drug: Etoposide; Radiation: Thoracic Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Investigator-assessed ORR per RECIST 1.1 in ES-SCLC patients treated with benmelstobart plus anlotinib and chemotherapy followed by thoracic radiotherapy.
Measured: Baseline at screening, after every 2 treatment cycles (each cycle is 21 days), end of treatment, up to disease progression, assessed up to approximately 24 months
Secondary outcomes (11)
Progression-Free Survival (PFS)
Time from first treatment to disease progression or death from any cause, whichever occurs first
Measured: Date of first study treatment to date of disease progression or death from any cause, last follow-up, assessed up to approximately 24 months
Overall Survival (OS)
Time from first study treatment to death from any cause; censored at last follow-up for alive subjects
Measured: From date of first study treatment to date of death from any cause or last follow-up, whichever occurs first, assessed up to approximately 24 months
6-Month Progression-Free Survival Rate
Estimated proportion of subjects without progression and alive at 6 months after first treatment using Kaplan-Meier method
Measured: 6-month time point after first treatment, follow-up cutoff
Serious Adverse Event (SAE)
Collect SAEs resulting in death, life-threatening condition, hospitalization, disability per CTCAE 5.0 and ICH-GCP, document and report
Measured: from date of first study drug administration , follow-up until resolution or stabilization, assessed up to approximately 24 months
Adverse Event (AE)
Record all new or worsening unfavorable medical events, grade and calculate incidence according to CTCAE 5.0
Measured: From signing informed consent through study completion and safety follow-up, assessed up to approximately 24 months
18-Month Overall Survival Rate
Estimated proportion of alive subjects at 18 months after first treatment via Kaplan-Meier method
Measured: 18-month time point after first treatment, follow-up cutoff
Duration of Response (DOR)
Time from first confirmed CR/PR to disease progression, death from any cause, or initiation of new antitumor therapy
Measured: From date of first confirmed objective response (CR/PR) until date of disease progression, death from any cause, or initiation of new antitumor therapy, whichever occurs first, assessed up to approximately 24 months
12-Month Progression-Free Survival Rate
Estimated proportion of progression-free and alive subjects at 12 months via Kaplan-Meier method
Measured: 12-month time point after first treatment, follow-up cutoff
12-Month Overall Survival Rate
Estimated proportion of alive subjects at 12 months after first treatment using Kaplan-Meier method
Measured: 12-month time point after first treatment, follow-up cutoff
Disease Control Rate (DCR)
According to RECIST 1.1, proportion of subjects achieving CR, PR, or stable disease (SD) in total enrolled population
Measured: Time Frame: Baseline and after every 2 treatment cycles (each cycle is 21 days), up to disease progression, death, or study withdrawal, whichever occurs first，assessed up to approximately 24 months
Immune-Related Adverse Event (irAE)
Identify and grade organ-specific immune-related adverse events according to CTCAE 5.0 and irAE criteria
Measured: From date of first study drug administration through 90 days after the last dose of study drug; assessed at baseline, each cycle visit, and unscheduled visits for suspected irAEs; graded per CTCAE 5.0 and irAE-specific criteria.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Mar 2029 (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.
- 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
- Model description
- Single-center, single-arm, open-label, non-randomized, exploratory interventional study.
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yayi He
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Sponsor-investigator, Yayi He, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538271
- Sponsor's protocol ID
- 2025LY12112
- Acronym
- Aurora 005
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing plans are currently undecided given the exploratory nature of this single-center study. Further assessment will be conducted based on study completion, data quality verification, and ethical considerations (e.g., participant privacy protection). A detailed sharing protocol will be finalized and disclosed as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Exploratory Clinical Study of Benmelstobart Combined With Anlotinib and Chemotherapy Followed by Thoracic Radiotherapy as First-line Treatment for Extensive-stage Small Cell Lung Cancer (ES-SCLC)
- ClinicalTrials.gov ID
- NCT07538271
- Acronym / sponsor ID
- Aurora 005 / 2025LY12112
- Conditions
- SCLC, Extensive Stage
- Keywords
- Small Cell Lung Cancer, Extensive-Stage, Benmelstobart, Anlotinib, Chemotherapy, Thoracic Radiotherapy, First-Line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Yayi HeUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 20 Apr 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 conducted at Shanghai Pulmonary Hospital, Tongji University. It aims to evaluate the efficacy and safety of first-line treatment with benmelstobart plus anlotinib and chemotherapy (carboplatin/cisplatin plus etoposide), followed by sequential thoracic radiotherapy, in patients with previously untreated extensive-stage small cell lung cancer (ES-SCLC).
Eligible participants will be adults aged 18-75 years with histologically or cytologically confirmed ES-SCLC, measurable lesions per RECIST 1.1, ECOG performance status 0-1, and adequate organ function. Patients will receive 4 cycles of induction therapy (benmelstobart, anlotinib, platinum-etoposide chemotherapy). Those without disease progression will receive consolidative thoracic radiotherapy, followed by maintenance therapy with benmelstobart plus anlotinib until disease progression or unacceptable toxicity.
The primary endpoint is objective response rate (ORR) assessed by investigators. Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety parameters including adverse events graded by CTCAE 5.0. A total of 33 subjects will be enrolled. This study uses a non-randomized, open-label design without a control group.
Detailed description
This is a single-center, single-arm, prospective, exploratory clinical trial to evaluate the efficacy and safety of first-line benmelstobart combined with anlotinib and platinum-etoposide chemotherapy, followed by sequential thoracic radiotherapy, in patients with untreated extensive-stage small cell lung cancer (ES-SCLC).
Eligible patients will receive 4 cycles of 21-day induction therapy consisting of intravenous benmelstobart 1200 mg on day 1, oral anlotinib 12 mg once daily for 2 weeks on / 1 week off, plus carboplatin (AUC 5) or cisplatin (75-80 mg/m²) on day 1 and etoposide 100 mg/m² on days 1-3 of each cycle. Patients without disease progression after induction therapy will receive consolidative thoracic radiotherapy (2 Gy per fraction, 25-30 fractions). Maintenance therapy with benmelstobart plus anlotinib will be administered until disease progression, unacceptable toxicity, or a maximum of 2 years.
The primary outcome is investigator-assessed objective response rate (ORR) per RECIST 1.1. Secondary outcomes include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety assessed by adverse events (AE, SAE, irAE) graded according to CTCAE version 5.0. A total of 33 subjects will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, single-arm, open-label, non-randomized, exploratory interventional study.
| Arm | Type | Receives |
|---|---|---|
| Benmelstobart + Anlotinib + Chemotherapy Followed by Thoracic Radiotherapy | Experimental | Drug: benmelstobart, Drug: Anlotinib, Drug: Carboplatin or cisplatin, Drug: Etoposide, Radiation: Thoracic RadiotherapyEligible patients receive 4 cycles of induction therapy (benmelstobart 1200mg IV D1 + anlotinib 12mg PO QD 2w-on/1w-off + carboplatin/cisplatin + etoposide). Non-progressive patients proceed to consolidative thoracic radiotherapy (2Gy/fraction, 25-30 fractions), followed by maintenance therapy with benmelstobart + anlotinib until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1: Histologically or cytologically confirmed inoperable extensive-stage small cell lung cancer (ES-SCLC) according to the VALG staging system
- 2: No prior systemic therapy for extensive-stage small cell lung cancer (ES-SCLC)
- 3: Presence of measurable lesions as defined by the RECIST 1.1 criteria. A previously irradiated lesion can be considered measurable only if there is clear progression after radiotherapy and it is not the sole lesion
- 4: Aged 18 to 75 years
- 5: ECOG performance status score of 0 to 1
Key exclusion criteria (10 listed)
- 1: Patients with symptomatic brain metastases. Patients whose brain metastases have been treated and remain clinically stable for at least 1 month, with no use of steroids or anticonvulsants for at least 1 month prior to study enrollment, are eligible
- 2: Prior use of anti-angiogenic agents such as anlotinib, apatinib, bevacizumab, or immune checkpoint inhibitors targeting PD-1, PD-L1, etc
- 3: Patients with conditions that affect oral drug administration (e.g., dysphagia, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.)
- 4: Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- 5: Patients with radiological evidence of tumor invasion around major blood vessels, or those judged by the investigator to be at high risk of fatal massive hemorrhage due to potential tumor invasion of major blood vessels during the study
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 |
|---|---|---|
| benmelstobartA PD-L1 inhibitor (biological product) administered intravenously. Used for immunotherapy in combination with other agents to treat extensive-stage small cell lung cancer (ES-SCLC). | Drug | Benmelstobart + Anlotinib + Chemotherapy Followed by Thoracic Radiotherapy |
| AnlotinibA small-molecule anti-angiogenic drug administered orally. Inhibits tumor angiogenesis to suppress tumor growth, used as part of the first-line combined therapy for ES-SCLC. | Drug | Benmelstobart + Anlotinib + Chemotherapy Followed by Thoracic Radiotherapy |
| Carboplatin or cisplatinA platinum-based chemotherapeutic agent administered intravenously. | Drug | Benmelstobart + Anlotinib + Chemotherapy Followed by Thoracic Radiotherapy |
| EtoposideA topoisomerase II inhibitor administered intravenously. Works by interfering with tumor cell replication, combined with platinum agents as first-line chemotherapy for ES-SCLC. | Drug | Benmelstobart + Anlotinib + Chemotherapy Followed by Thoracic Radiotherapy |
| Thoracic RadiotherapyExternal beam radiation therapy delivered to the thoracic region. Administered as consolidative treatment for non-progressive ES-SCLC patients after induction therapy, with a total dose based on clinical practice guidelines. | Radiation | Benmelstobart + Anlotinib + Chemotherapy Followed by Thoracic Radiotherapy |
Primary outcome
Objective Response Rate (ORR)
Time frame: Baseline at screening, after every 2 treatment cycles (each cycle is 21 days), end of treatment, up to disease progression, assessed up to approximately 24 months
Investigator-assessed ORR per RECIST 1.1 in ES-SCLC patients treated with benmelstobart plus anlotinib and chemotherapy followed by thoracic radiotherapy.
11 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Date of first study treatment to date of disease progression or death from any cause, last follow-up, assessed up to approximately 24 months
Overall Survival (OS)
Time frame: From date of first study treatment to date of death from any cause or last follow-up, whichever occurs first, assessed up to approximately 24 months
6-Month Progression-Free Survival Rate
Time frame: 6-month time point after first treatment, follow-up cutoff
Serious Adverse Event (SAE)
Time frame: from date of first study drug administration , follow-up until resolution or stabilization, assessed up to approximately 24 months
Adverse Event (AE)
Time frame: From signing informed consent through study completion and safety follow-up, assessed up to approximately 24 months
18-Month Overall Survival Rate
Time frame: 18-month time point after first treatment, follow-up cutoff
Duration of Response (DOR)
Time frame: From date of first confirmed objective response (CR/PR) until date of disease progression, death from any cause, or initiation of new antitumor therapy, whichever occurs first, assessed up to approximately 24 months
12-Month Progression-Free Survival Rate
Time frame: 12-month time point after first treatment, follow-up cutoff
12-Month Overall Survival Rate
Time frame: 12-month time point after first treatment, follow-up cutoff
Disease Control Rate (DCR)
Time frame: Time Frame: Baseline and after every 2 treatment cycles (each cycle is 21 days), up to disease progression, death, or study withdrawal, whichever occurs first，assessed up to approximately 24 months
Immune-Related Adverse Event (irAE)
Time frame: From date of first study drug administration through 90 days after the last dose of study drug; assessed at baseline, each cycle visit, and unscheduled visits for suspected irAEs; graded per CTCAE 5.0 and irAE-specific criteria.
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 20 Apr 2026.
- Individual participant dataSharing planned: Undecided. IPD sharing plans are currently undecided given the exploratory nature of this single-center study. Further assessment will be conducted based on study completion, data quality verification, and ethical considerations (e.g., participant privacy protection). A detailed sharing protocol will be finalized and disclosed as appropriate.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing benmelstobart, Anlotinib and Carboplatin or cisplatin in people with SCLC, Extensive Stage, run by Yayi He.
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 10 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 20 Apr 2026. 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 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 Yayi He, MD (021-65115006-2393, yayi.he@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Baseline at screening, after every 2 treatment cycles (each cycle is 21 days), end of treatment, up to disease progression, assessed 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 20 Apr 2026.