Carboplatin/Cisplatin + Etoposide + Benmelstobart Sequential Benmelstobart Combined With Anlotinib Versus Carboplatin/Cisplatin + Etoposide + Tislelizumab Sequential Tislelizumab in the Treatment of Extensive Stage Small Cell Lung Cancer

NCT06897579 | Terminated Phase 2

• 1 other identifier: TQB2450-ALTN-II-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 32

Brief Summary

This is a randomized, controlled, open-label, multicenter clinical study to evaluate the efficacy and safety of carboplatin/cisplatin + etoposide + benmelstobart sequential benmelstobart combined with anlotinib versus carboplatin/cisplatin + etoposide + Tislelizumab sequential Tislelizumab in the first-line treatment of extensive stage small cell lung cancer.

Conditions

Extensive Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  The time from enrollment until the first onset of disease progression or death from any cause, whichever occurs first.

  From enrollment until the first onset of disease progression or death from any cause, evaluation is expected to take 2 years

Secondary Outcomes (9)

• 12/24 month PFS rate

  12-month, 24-month

• 12/24 month Overall survival (OS) rate

  12-month, 24-month

• Overall survival (OS)

  From randomization to death from all causes, evaluation is expected to take 5 years

• Objective response rate (ORR)

  Complete response time was achieved, evaluation is expected to take 2 years

• Disease Control Rate (DCR)

  Complete response time was achieved, evaluation is expected to take 2 years

Study Arms (2)

Carboplatin/cisplatin + etoposide + benmelstobart + Anlotinib hydrochloride

EXPERIMENTAL

Induction treatment period：Carboplatin for injection/Cisplatin for injection + etoposide injection + benmelstobart injection, intravenous infusion, 21 days 1 cycle (etoposide injection on the 2nd and 3rd day of each cycle) Maintenance treatment period: benmelstobart injection, intravenous drip, 21 days 1 cycle；Anlotinib hydrochloride capsules were taken orally on an empty stomach for 2 consecutive weeks and stopped for 1 week.

Drug: Carboplatin for injection/cisplatin for injection + etoposide injection + benmelstobart injection + Anlotinib hydrochloride capsule

Carboplatin /Cisplatin + etoposide + Tislelizumab

ACTIVE COMPARATOR

Induction treatment period：Carboplatin for injection/Cisplatin for injection + etoposide injection + Tislelizumab injection, intravenous infusion, 21 days, 1 cycle (etoposide injection on the 2nd and 3rd day of each cycle) Maintenance treatment period：Tislelizumab injection, intravenous drip, 21 days 1 cycle.

Drug: Carboplatin for injection/Cisplatin for injection + etoposide injection + Tislelizumab injection

Interventions

Carboplatin for injection/Cisplatin for injection + etoposide injection + Tislelizumab injection DRUG

Carboplatin for injection inhibits DNA synthesis and thus prevents the division and reproduction of cancer cells/Cisplatin for injection binds to DNA and interferes with the DNA replication and transcription process, thereby inhibiting the proliferation of tumor cells/etoposide injection interferes with the division process of cancer cells to inhibit their growth and spread/Tislelizumab injection is a humanized recombinant anti-PD-1 monoclonal antibody.

Carboplatin /Cisplatin + etoposide + Tislelizumab

Carboplatin for injection/cisplatin for injection + etoposide injection + benmelstobart injection + Anlotinib hydrochloride capsule DRUG

Carboplatin for injection inhibits DNA synthesis, thereby preventing cancer cell division and reproduction/Cisplatin for injection binds to DNA, interfering with DNA replication and transcription processes, Thus inhibiting tumor cell proliferation/etoposide injection interferes with the division process of cancer cells to inhibit their growth and spread/Bemosubebezumab injection is a humanized recombinant anti-Programmed cell death ligand 1 (PD-L1) monoclonal antibody/Anlotinib hydrochloride capsule is a tyrosine kinase inhibitor.

Carboplatin/cisplatin + etoposide + benmelstobart + Anlotinib hydrochloride

Eligibility Criteria

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

You may qualify if:

• The subjects voluntarily joined the study, signed the informed consent, and had good compliance;
• years old ≤age≤ 75 years old (calculated on the date of signing the informed consent);
• Eastern Cooperative Oncology Group (ECOG) score 0 \~ 1;
• Expected survival greater than 12 weeks.
• Histologically or cytologically confirmed Extensive stage small cell lung cancer (ES-SCLC) (according to the Veterans Administration Lung Cancer Society (VALG) disease staging system).
• had not received systemic therapy for ES-SCLC (including systemic chemotherapy, molecular targeted drug therapy, biological therapy and other investigational therapeutic drugs, etc.) or immune checkpoint inhibitor therapy.
• Patients receiving chemoradiotherapy for previously limited-stage SCLC must be treated for cure, and there must be a treatment-free interval of at least 6 months from the last course of chemotherapy, radiotherapy, or chemoradiotherapy to the diagnosis of extensive SCLC.
• Confirmed presence of at least one measurable lesion according to RECIST 1.1 criteria. Note: Measurable target lesions cannot be selected from previous radiotherapy sites. If the target lesion of the previous radiotherapy site is the only alternative target lesion, the investigator should provide pre - and post-imaging data showing significant progression of the lesion.
• Laboratory inspection meets the following standards:
• Hemoglobin (HGB) ≥ 90g/L;
• Neutrophil absolute value (NEUT) ≥ 1.5× 10 9 /L;
• Platelet count (PLT) ≥ 90× 10 9 /L;
• Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN);
• Alanine transferase (ALT) and aspartate transferase (AST) ≤ 2.5×ULN. ALT and AST≤ 5×ULN if accompanied by liver metastasis;
• Serum creatinine (CR) ≤ 1.5×ULN or creatinine clearance (CCR) ≥60 mL /min;

You may not qualify if:

• Had or was currently suffering from other malignant tumors within 3 years prior to the first medication. The following two conditions can be included: other malignancies treated with a single operation, achieving continuous 5-year disease-free survival (DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta(non-invasive tumor), Tis (cancer in situ) and T1 (tumor infiltrating basal membrane)\].
• The presence of diseases affecting intravenous administration, intravenous blood collection, or multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
• The adverse effects of previous treatment did not return to The Common Terminology Criteria for Adverse Events (CTCAE) v5.0 score ≤ 1, except for grade 2 alopecia, grade 2 peripheral neurotoxicity, grade 2 anemia, non-clinically significant and asymptomatic laboratory abnormalities, stable hypothyroidism after hormone replacement therapy and other toxicities deemed by the investigators to be of no safety risk.
• Those who have received major surgical treatment, significant traumatic injury, or major surgery during the intended study treatment period (other than protocol-specified surgery) within the 4 weeks prior to initial medication, or have sustained unhealed wounds or fractures. (Major surgery is defined as surgery at grade 3 and above in the National Surgical Grading Directory 2022 edition).
• Subjects with any bleeding or bleeding event ≥ CTC AE grade 3 within 4 weeks prior to initial dosing.
• Patients who experienced a hyperarterial/venous thrombosis event, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, within 6 months before the first administration of the drug.
• Active viral hepatitis and poorly controlled. Those who meet the following requirements can be screened: HBsAg positive subjects must meet Hepatitis B virus (HBV) DNA quantification \<2000 IU/ml (or 1\*104 copy/ml) or receive anti-HBV therapy with a 10-fold (1 log) or greater reduction in viral index for at least 1 week prior to study initiation, and subjects are willing to receive anti-HBV therapy throughout the study period; HCV infected persons (HCV Ab or HCV RNA positive) : The investigators judged to be in a stable state or were receiving antiviral therapy at enrollment and continued to receive approved antiviral therapy in the study.
• Patients with active syphilis who need treatment;
• There is a history of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment, or active pneumonia with clinical symptoms.
• Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders.
• People who are preparing for or have previously received allogeneic bone marrow transplantation or solid organ transplantation.
• History of hepatic encephalopathy.
• Major cardiovascular disease, including any of the following:
• According to the New York Heart Association (NYHA) standards of grade II or higher cardiac insufficiency or heart color ultrasound: left ventricular ejection fraction (LVEF) \<50%;
• There is a history of clinically significant ventricular arrhythmias (such as persistent ventricular tachycardia, ventricular fibrillation, tip torsion ventricular tachycardia) or arrhythmias requiring continuous antiarrhythmic drug treatment;

Sponsors & Collaborators

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

Study Sites (32)

Maanshan People's Hospital

Maanshan, Anhui, 243000, China

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

Location

Peking University People´s Hospital

Beijing, Beijing Municipality, 100044, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Fujian Medical University 2nd Affiliated Hospital

Quanzhou, Fujian, 362001, China

Location

The Second Hospitai. & Clinicae Medical School . Lanzhou University

Lanzhou, Gansu, 730030, China

Location

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, 510000, China

Location

Nanfang Hospital

Guangzhou, Guangzhou, 510515, China

Location

The fourth hospital of hebei medical university

Shijiazhuang, Hebei, 05000, China

Location

Tangshan People's Hospital

Tangshan, Hebei, 063001, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

Location

The Second People's Hosital of Jiaozuo

Jiaozuo, Henan, 454001, China

Location

Henan Provincial People'S Hospital

Zhengzhou, Henan, 450003, China

Location

Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou, Henan, 457000, China

Location

Jingzhou Central Hospital

Jingzhou, Hubei, 434000, China

Location

Huazhong University of Science and Technology Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

Baotou Cancer Hospital

Baotou, Inner Mongolia, 014000, China

Location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

Location

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, 121001, China

Location

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110000, China

Location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

Shenyang Tenth People's Hospital

Shenyang, Liaoning, 110044, China

Location

The First Affiliated Hospital of Shandong First Medical University

Jinnan, Shandong, 250000, China

Location

Linyi City People's Hospital

Linyi, Shandong, 276003, China

Location

The Second Affiliated Hospital Of Xi'an Jiaotong University

Xi'an, Shannxi, 710000, China

Location

Shanxi Cancer hospital

Taiyuan, Shanxi, 30000, China

Location

Sichuan cancer hospital

Chengdu, Sichuan, 610042, China

Location

Dongyang Municipal People's Hospital

Dongyang, Zhejiang, 522031, China

Location

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, 315000, China

Location

Ningbo No.2 Hospital

Ningbo, Zhejiang, 315010, China

Location

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, 317000, China

Location

MeSH Terms

Interventions

Carboplatin; Injections; Cisplatin; Etoposide; tislelizumab

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 27, 2025
• Study Start: April 7, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: April 28, 2026

Record last verified: 2025-04

Locations

CN (32)