A Randomized Controlled, Open-label, Multicenter Clinical Trial Evaluating the Efficacy and Safety of Carboplatin/Cisplatin + Etoposide + Bemarituzumab Followed by Bemarituzumab Combined With Anlotinib Versus Carboplatin/Cisplatin + Etoposide + Tislelizumab Followed by Tislelizumab as First-line Treatment for Extensive-stage Small Cell Lung Cancer

Status: Recruiting
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

⁃ The subjects voluntarily joined the study, signed the informed consent, and had good compliance;

⁃ 18 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;

‣ Prothrombin time (PT), activated partial thromboplastin time (APTT), International standardized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy).

⁃ Women of reproductive age should agree that effective contraception must be used during the study period and for 6 months after the end of the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for 6 months after the end of the study period.

Locations
Other Locations
China
Baotou Cancer Hospital
NOT_YET_RECRUITING
Baotou
Beijing Cancer Hospital
NOT_YET_RECRUITING
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Peking University People´s Hospital
NOT_YET_RECRUITING
Beijing
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Sichuan cancer hospital
NOT_YET_RECRUITING
Chengdu
Dongyang Municipal People's Hospital
NOT_YET_RECRUITING
Dongyang
Nanfang Hospital
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
The First Affiliated Hospital of Shandong First Medical University
RECRUITING
Jinnan
The Second Hospitai. & Clinicae Medical School . Lanzhou University
NOT_YET_RECRUITING
Lanzhou
Linyi City People's Hospital
NOT_YET_RECRUITING
Linyi
Maanshan People's Hospital
NOT_YET_RECRUITING
Maanshan
Jiangsu Cancer Hospital
NOT_YET_RECRUITING
Nanjing
Ningbo Medical Center Lihuili Hospital
NOT_YET_RECRUITING
Ningbo
Ningbo No.2 Hospital
NOT_YET_RECRUITING
Ningbo
Fujian Medical University 2nd Affiliated Hospital
NOT_YET_RECRUITING
Quanzhou
Cancer Hospital of Shantou University Medical College
NOT_YET_RECRUITING
Shantou
Liaoning Cancer Hospital & Institute
NOT_YET_RECRUITING
Shenyang
The First Affiliated Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
The fourth hospital of hebei medical university
NOT_YET_RECRUITING
Shijiazhuang
Shanxi Cancer hospital
NOT_YET_RECRUITING
Taiyuan
Taizhou Hospital of Zhejiang Province
NOT_YET_RECRUITING
Taizhou
Tangshan People's Hospital
NOT_YET_RECRUITING
Tangshan
Huazhong University of Science and Technology Tongji Medical College of Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
The Second Affiliated Hospital Of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Henan Provincial People'S Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Jie Wang, Doctor
yaqian.zhao@halmaorient.com
18210531707
Backup
Dongqing Lv, Master
lvdq@enzemed.com
13867622009
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2027-04
Participants
Target number of participants: 134
Treatments
Experimental: Carboplatin/cisplatin + etoposide + benmelstobart + Anlotinib hydrochloride
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.
Active_comparator: Carboplatin /Cisplatin + etoposide + Tislelizumab
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.
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

This content was sourced from clinicaltrials.gov