AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer

RecruitingPhase 2Ages 18 Years - anyAllSecond Affiliated Hospital, Zhejiang University, โ€ฆ
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: * Age โ‰ฅ18 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). Key Exclusion Criteria: * Previously receiving systemic anti-tumor therapy for ES-SCLC; * Combined SCLC (mixed SCLC and NSCLC histological types) or transformed SCLC confirmed by histological or cytological examination; * 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; * Active central nervous system (CNS) metastases (asymptomatic patients with stable lesions allowed); * Severe cardiovascular disease; * Severe chronic/active infections requiring systemic antibacterial, antifungal or antiviral treatment within 2 weeks before enrollment; * 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; * Pregnancy or lactation; * Having a disease that requires systemic corticosteroids or other immunosuppressants to be treated within โ‰ค14 days before enrollment; * Requiring at least monthly or more frequent drainage of pleural and/or pericardial or peritoneal effusion; * Using attenuated live vaccines, or planned to receive attenuated live vaccines within 28 days before enrollment; * 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; * Toxicity caused by previous anti-cancer treatment has not recovered to baseline or stable state at the time of enrollment; * Creatinine clearance rate \< 60 mL/min (cisplatin) or \< 45 mL/min (carboplatin) * Uncontrolled or symptomatic hypercalcemia.
๐Ÿ’Š

What it tests

  • Tafolecimab
  • Sintilimab (approved)
  • Etoposide
  • Carboplatin / Cisplatin
๐Ÿ“

Where

5 sites
Hunan Cancer Hospital/the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, China
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science
Jinan, China
Department of Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences
Hangzhou, China
First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy