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Limited-stage Small Cell Lung Cancer (LS-SCLC)Phase 2Aurora004NCT07538258

Benmelstobart Plus Anlotinib, Chemotherapy and Thoracic Radiation for Limited-Stage Small Cell Lung Cancer

A Phase 2 study testing Benmelstobart, Anlotinib and Cisplatin or carboplatin in people with Limited-stage Small Cell Lung Cancer (LS-SCLC), run by Yayi He.

Not yet recruiting

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

Sites and contacts
Official record
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Trial summary

This is a single-arm, single-center, exploratory clinical study conducted at Shanghai Pulmonary Hospital, Tongji University. The study evaluates the effectiveness and safety of first-line treatment with benmelstobart (an immunotherapy), anlotinib (an anti-angiogenic drug), platinum-etoposide chemotherapy, and… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Benmelstobart, Anlotinib and Cisplatin or carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 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 limited-stage small cell lung cancer (LS-SCLC) (per VALG staging).
  • 2: No prior systemic therapy for limited-stage small cell lung cancer
  • 3: Presence of measurable lesions as defined by RECIST 1.1. A previously irradiated lesion may be considered measurable only if it has demonstrated clear progression after radiotherapy and is not the sole lesion
  • 4: Age ≥ 18 and ≤ 75 years
  • 5: ECOG performance status: 0-1
  • 6: Expected survival ≥ 3 months
  • 7: Adequate hematologic and organ function, defined as meeting the following criteria: a) Hematologic function (no transfusion of blood or blood products, no G-CSF or other hematopoietic growth factors within 14 days): 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 (CrCl) ≥ 50 mL/min; ii. Urine protein < 2+ or 24-hour urine protein quantification < 1.0 g. c) Hepatic function: i. Serum total bilirubin (TBil) ≤ 1.5 × ULN; ii. AST and ALT ≤ 2.5 × 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%.
  • 8: Subjects voluntarily participate in this study, provide written informed consent, demonstrate good compliance, and agree to comply with follow-up procedures.

Who cannot join

  • 1: Prior use of anti-angiogenic agents such as anlotinib, apatinib, bevacizumab, or related immunotherapeutic agents targeting PD-1, PD-L1, etc
  • 2: Presence of multiple factors affecting oral medication absorption (e.g., inability to swallow, status post gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.).
  • 3: Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • 4: Patients with imaging evidence of tumor invasion adjacent to major blood vessels, or judged by the investigator to have a high risk of fatal massive hemorrhage due to tumor invasion of major blood vessels during the subsequent study period.
  • 5: History of severe bleeding tendency or coagulopathy, including but not limited to: clinically significant hemoptysis (more than one tablespoon per day) within 3 months prior to enrollment; or clinically significant bleeding symptoms or bleeding diathesis within 4 weeks prior to randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer (including gastrointestinal perforation and/or fistula; however, patients with surgically repaired gastrointestinal perforation or fistula may be eligible), unhealed wounds, ulcers, or fractures, etc.
  • 6: Undergoing major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to randomization.
Show all 9Show fewer
  • 7: History of arterial/venous thrombotic events within 6 months prior to randomization, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism.
  • 8: Development of active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose.
  • 9: Any other conditions that, in the judgment of the investigator, would render the patient ineligible for study enrollment.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yayi He, MD contact

021-65115006-2393

yayi.he@tongji.edu.cn

About this study

Official title: A Single-Arm, Exploratory Clinical Study of Benmelstobart Combined With Anlotinib and Chemotherapy Concurrent With Thoracic Radiotherapy as First-Line Treatment in Limited-Stage Small Cell Lung Cancer (LS-SCLC)

This is a single-arm, single-center, exploratory clinical study conducted at Shanghai Pulmonary Hospital, Tongji University. The study evaluates the effectiveness and safety of first-line treatment with benmelstobart (an immunotherapy), anlotinib (an anti-angiogenic drug), platinum-etoposide chemotherapy, and concurrent thoracic radiotherapy in participants with previously untreated, unresectable limited-stage small cell lung cancer (LS-SCLC).

Eligible participants are aged 18 to 75 years, with histologically or cytologically confirmed limited-stage SCLC (VALG staging), no prior systemic treatment for lung cancer, measurable lesions by RECIST 1.1, ECOG performance status 0-1, and adequate organ function.

Read more

Participants receive 4 cycles of induction therapy (21 days per cycle), including benmelstobart intravenously every 3 weeks, anlotinib orally for 2 weeks on / 1 week off, and chemotherapy with carboplatin or cisplatin plus etoposide. Thoracic radiotherapy (60-70 Gy in 30-35 fractions) is given concurrently with chemotherapy cycles 1-3. After induction, participants receive maintenance therapy with benmelstobart plus anlotinib for up to 2 years or until disease progression or unacceptable side effects.

The primary objective is to assess the Objective Response Rate (ORR) as evaluated by investigators using RECIST 1.1. Secondary objectives include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety assessments of adverse events graded by CTCAE 5.0.

A total of 27 participants will be enrolled. The study is expected to start in March 2026, complete enrollment by September 2027, and end in March 2029. All participants will be regularly followed for efficacy and safety.

Being tested
Benmelstobart, Anlotinib, Cisplatin or carboplatin, Etoposide, Thoracic Radiation Therapy
Keywords
Limited-stage small cell lung cancer, benmelstobart, anlotinib, chemotherapy
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

    Also called TQB2450, Andewei

    Anti-PD-L1 monoclonal antibody, immunotherapy.1200 mg/dose, Q21D (1 cycle), IV infusion.

  • AnlotinibDrug

    Also called AL3818

    Small molecule multi-target anti-angiogenic agent.12 mg/day, oral (2 weeks on/1 week off, repeated Q3W), taken with water at fixed time.

  • Cisplatin or carboplatinDrug

    Chemotherapy agent.Carboplatin: Day 1, AUC 5 mg/mL/min (max 750 mg), IV infusion; Cisplatin: Day 1, 75-80 mg/m², IV infusion.

  • EtoposideDrug

    Chemotherapy agent. Days 1-3, 100 mg/m², IV infusion.

  • Thoracic Radiation TherapyRadiation

    External beam intensity-modulated radiotherapy (IMRT) targeting the primary thoracic tumor, ipsilateral hilum, and mediastinal lymph node stations (per LS-SCLC staging guidelines). Initiated with Cycle 1 of chemotherapy; IMRT, 60-70 Gy in 30-35 fractions (1.8-2.0 Gy/fraction, once daily); target volumes: primary tumor + lymph nodes delineated on post-chemotherapy CT, investigator-adjusted individually.

Study groups in NCT07538258
Study groupRoleWhat they receive
Benmelstobart combined with anlotinib and chemotherapy concurrent with thoracic radiotherapyExperimentalBenmelstobart combined with anlotinib plus chemotherapy concurrent with thoracic radiotherapy for limited-stage small cell lung cancer. Benmelstobart Injection: 1200 mg/dose, Q21D (1 cycle), IV infusion. Anlotinib Hydrochloride Capsules: 12 mg/day, oral (2 weeks on/1 week off, repeated Q3W), taken with water at fixed time. Chemotherapy: Carboplatin: Day 1, AUC 5 mg/mL/min (max 750 mg), IV infusion; Cisplatin: Day 1, 75-80 mg/m², IV infusion; Etoposide: Days 1-3, 100 mg/m², IV infusion. Concurrent Thoracic Radiation: Initiated with Cycle 1 of chemotherapy; IMRT, 60-70 Gy in 30-35 fractions (1.8-2.0 Gy/fraction, once daily); target volumes: primary tumor + lymph nodes delineated on post-chemotherapy CT, investigator-adjusted individually.
Receives: Drug: Benmelstobart; Drug: Anlotinib; Drug: Cisplatin or carboplatin; Drug: Etoposide; Radiation: Thoracic Radiation Therapy

What is being measured

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

  1. Investigator-Assessed Objective Response Rate

    According to RECIST 1.1 criteria, investigator assesses target lesion changes via imaging; calculates the proportion of subjects achieving complete response (CR) or partial response (PR)

    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)

  1. 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

  2. 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

  3. 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.

  4. Progression-Free Survival (PFS)

    Time from first treatment to disease progression or death from any cause, whichever occurs first

    Measured: From date of first study drug administration until the date of first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first; assessed up to 24 months (maximum follow-up period).

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

Timeline

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

  1. First posted20 Apr 2026
  2. Study start20 Apr 2026 (estimated)
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

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
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07538258
Sponsor's protocol ID
2025LY12113
Other IDs
MR-31-26-022322
Acronym
Aurora004
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: The decision to share individual participant data (IPD) is currently undecided. This is an exploratory single-center clinical study, and IPD sharing will be re-evaluated after study completion and primary results analysis. Factors to be considered include the protection of participant privacy, compliance with ethical committee requirements, and the scientific validity of secondary research using the shared data. If IPD sharing is approved in the future, access will be provided in accordance with ClinicalTrials.gov guidelines and relevant regulatory requirements.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Benmelstobart, Anlotinib and Cisplatin or carboplatin in people with Limited-stage Small Cell Lung Cancer (LS-SCLC), 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 8 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: 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?

Investigator-Assessed Objective Response Rate (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?

On the ClinicalTrials.gov record for NCT07538258.

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; AzTrials last refreshed its copy on 8 Nov 2026.

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