RecruitingPhase 2NCT06897579

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

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

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Enrollment

134 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two immunotherapy-based treatment regimens for extensive-stage small cell lung cancer (SCLC) — a fast-growing type of lung cancer. One regimen combines chemotherapy with benmelstobart (followed by benmelstobart plus a targeted drug called anlotinib), while the other uses tislelizumab (an established immunotherapy drug) combined with chemotherapy. The goal is to find out which combination leads to better outcomes and what side effects each causes. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with extensive-stage small cell lung cancer, confirmed by biopsy - You have not received any prior treatment for extensive-stage SCLC - You are physically well enough to participate (ECOG score 0–1) - Your expected survival is more than 12 weeks - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You have previously received chemotherapy, immunotherapy, or targeted therapy for extensive-stage SCLC - You have active brain metastases that are causing symptoms - You have autoimmune disease or are on long-term steroid treatment - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCarboplatin for injection/cisplatin for injection + etoposide injection + benmelstobart injection + Anlotinib hydrochloride capsule

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.

DRUGCarboplatin for injection/Cisplatin for injection + etoposide injection + Tislelizumab injection

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.

Locations(32)

Maanshan People's Hospital

Maanshan, Anhui, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Peking University People´s Hospital

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Fujian Medical University 2nd Affiliated Hospital

Quanzhou, Fujian, China

The Second Hospitai. & Clinicae Medical School . Lanzhou University

Lanzhou, Gansu, China

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

Nanfang Hospital

Guangzhou, Guangzhou, China

The fourth hospital of hebei medical university

Shijiazhuang, Hebei, China

Tangshan People's Hospital

Tangshan, Hebei, China

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The Second People's Hosital of Jiaozuo

Jiaozuo, Henan, China

Henan Provincial People'S Hospital

Zhengzhou, Henan, China

Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou, Henan, China

Jingzhou Central Hospital

Jingzhou, Hubei, China

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

Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Baotou Cancer Hospital

Baotou, Inner Mongolia, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Shenyang Tenth People's Hospital

Shenyang, Liaoning, China

The First Affiliated Hospital of Shandong First Medical University

Jinnan, Shandong, China

Linyi City People's Hospital

Linyi, Shandong, China

The Second Affiliated Hospital Of Xi'an Jiaotong University

Xi'an, Shannxi, China

Shanxi Cancer hospital

Taiyuan, Shanxi, China

Sichuan cancer hospital

Chengdu, Sichuan, China

Dongyang Municipal People's Hospital

Dongyang, Zhejiang, China

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

Ningbo No.2 Hospital

Ningbo, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

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NCT06897579