A Study of Benmelstobart, Anlotinib, Chemotherapy and Thoracic Radiotherapy for People With Extensive-stage Small Cell Lung Cancer

NCT07538271 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025LY12112
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

SCLC, Extensive Stage

Keywords

Small Cell Lung Cancer; Extensive-Stage; Benmelstobart; Anlotinib; Chemotherapy; Thoracic Radiotherapy; First-Line

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  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

  6-month time point after first treatment, follow-up cutoff

• Serious Adverse Event (SAE)

  from date of first study drug administration , follow-up until resolution or stabilization, assessed up to approximately 24 months

• Adverse Event (AE)

  From signing informed consent through study completion and safety follow-up, assessed up to approximately 24 months

Study Arms (1)

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.

Drug: benmelstobart; Drug: Anlotinib; Drug: Carboplatin or cisplatin; Drug: Etoposide; Radiation: Thoracic Radiotherapy

Interventions

benmelstobart DRUG

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).

Benmelstobart + Anlotinib + Chemotherapy Followed by Thoracic Radiotherapy

Anlotinib DRUG

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.

Benmelstobart + Anlotinib + Chemotherapy Followed by Thoracic Radiotherapy

Etoposide DRUG

A topoisomerase II inhibitor administered intravenously. Works by interfering with tumor cell replication, combined with platinum agents as first-line chemotherapy for ES-SCLC.

Benmelstobart + Anlotinib + Chemotherapy Followed by Thoracic Radiotherapy

Thoracic Radiotherapy RADIATION

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.

Benmelstobart + Anlotinib + Chemotherapy Followed by Thoracic Radiotherapy

Carboplatin or cisplatin DRUG

A platinum-based chemotherapeutic agent administered intravenously.

Benmelstobart + Anlotinib + Chemotherapy Followed by Thoracic Radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• : Histologically or cytologically confirmed inoperable extensive-stage small cell lung cancer (ES-SCLC) according to the VALG staging system
• : No prior systemic therapy for extensive-stage small cell lung cancer (ES-SCLC)
• : 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
• : Aged 18 to 75 years
• : ECOG performance status score of 0 to 1
• : Expected survival time ≥ 3 months
• : 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
• : 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
• : 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

You may not qualify if:

• : 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
• : Prior use of anti-angiogenic agents such as anlotinib, apatinib, bevacizumab, or immune checkpoint inhibitors targeting PD-1, PD-L1, etc
• : Patients with conditions that affect oral drug administration (e.g., dysphagia, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.)
• : Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
• : 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
• : 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
• : Receipt of major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to group assignment
• : 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
• : 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
• : 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

Sponsors & Collaborators

• Yayi He: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

anlotinib; Carboplatin; Cisplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Central Study Contacts

Yayi He, MD

CONTACT

021-65115006-2393; yayi.he@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study with no masking applied to any parties involved in the trial.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Single-center, single-arm, open-label, non-randomized, exploratory interventional study.

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 20, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 31, 2029
• Last Updated: April 20, 2026

Record last verified: 2026-03