Tests sintilimab and tafolecimab with chemotherapy for extensive small cell lung cancer
Tests sintilimab, tafolecimab and chemotherapy in adults with extensive-stage small cell lung cancer.
Plain-language title generated from the registry record
Registry title: Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
Key facts
- Where
- Changsha, Hangzhou, and Jinan, ChinaSee the 5 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with extensive-stage small cell lung cancer who have not yet had drug treatment for it. They get tafolecimab, sintilimab and chemotherapy.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Extensive-stage small cell lung cancer, confirmed by tissue or cell tests. At least 1 measurable tumor lesion. Good daily activity level (ECOG 0-1). Expected survival of at least 12 weeks.
- Earlier treatment
- No earlier systemic (whole-body) treatment for extensive-stage small cell lung cancer.
Main reasons for not taking part
- Mixed or transformed small cell lung cancer
- Active brain or spinal cord (CNS) metastases (stable, symptom-free ones are allowed)
- Active hepatitis B, hepatitis C or HIV infection
- Active autoimmune disease or a history of interstitial lung disease
- Pregnancy or breastfeeding
Read by machine on 12 November 2026.
Where in China
- Hunan Cancer Hospital(The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South UniversityChangsha, ChinaContact: Yongchang Zhang, MD, PhDNot yet recruiting
- Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of SciencesHangzhou, ChinaContact: Jing Qin, MD, PhDTaking people
- First Affiliated Hospital, School of Medicine, Zhejiang UniversityHangzhou, ChinaContact: Jian Ruan, MD, PhDTaking people
- Second Affiliated Hospital, School of Medicine, Zhejiang UniversityHangzhou, ChinaContact: Yang Xia, MD, PhDTaking people
- Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical ScienceJinan, ChinaContact: Xiangjiao Meng, MD, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT07061535
- Record updated
- 15 September 2026
- Original description
This is a single arm, multi-center clinical trial. The goal of this clinical trial is to evaluate the efficacy, safety and biomarkers of Tafolecimab combined with Sintilimab and Chemotherapy as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). Tafolecimab is a recombinant fully humanized monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK-9), which can reduce low-density lipoprotein-C levels and increase the expression level of major histocompatibility complex class I (MHC-I) on tumor cells. Sintilimab is a fully humanized IgG4 monoclonal antibody targeting programmed cell death protein 1 (PD-1).Read full original descriptionShow less
Efficacy and Safety of Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (STAR-SCLC)：A Prospective, Single Arm Trial
This is a single arm, multi-center clinical trial. The goal of this clinical trial is to evaluate the efficacy, safety and biomarkers of Tafolecimab combined with Sintilimab and Chemotherapy as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). Tafolecimab is a recombinant fully humanized monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK-9), which can reduce low-density lipoprotein-C levels and increase the expression level of major histocompatibility complex class I (MHC-I) on tumor cells. Sintilimab is a fully humanized IgG4 monoclonal antibody targeting programmed cell death protein 1 (PD-1).
Inclusion: Age ≥18 years, ECOG performance status 0-1; Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to Veterans Administration Lung Study Group criteria; Previously not receiving systemic treatment for ES-SCLC; Greater than or equal to 1 measurable lesion exists according to RECIST v1.1; Expected survival >= 12 weeks; Adequate organ system functions (no blood transfusion or component blood use within 14 days before testing).
Exclusion: Previously receiving systemic anti-tumor therapy for ES-SCLC; Receiving other investigational drugs or participated in other interventional clinical studies within 4 weeks before signing the informed consent form; Receiving systemic immunostimulant treatment within 4 weeks before enrollment; Severe chronic/active infections requiring systemic antibacterial, antifungal or antiviral treatment within 2 weeks before enrollment; Having a disease that requires systemic corticosteroids or other immunosuppressants to be treated within ≤14 days before enrollment; Using attenuated live vaccines, or planned to receive attenuated live vaccines within 28 days before enrollment; Toxicity caused by previous anti-cancer treatment has not recovered to baseline or stable state at the time of enrollment; Severe cardiovascular disease; Active hepatitis B virus (HBV)/ hepatitis C virus (HCV)/ human immunodeficiency virus (HIV) infection; Active autoimmune diseases, a history of interstitial lung disease, or other uncontrolled systemic diseases; Known to be allergic to Sintilimab or Tafolecimab or its excipients, having a history of severe allergic reaction to any monoclonal antibody, or having a history of allergy to cisplatin, carboplatin or etoposide; Creatinine clearance rate < 60 mL/min (cisplatin) or < 45 mL/min (carboplatin); Combined SCLC (mixed SCLC and NSCLC histological types) or transformed SCLC confirmed by histological or cytological examination; Active central nervous system (CNS) metastases (asymptomatic patients with stable lesions allowed); Pregnancy or lactation; Requiring at least monthly or more frequent drainage of pleural and/or pericardial or peritoneal effusion; Uncontrolled or symptomatic hypercalcemia.