Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage… (NCT07061535) | Clinical Trial Compass
RecruitingPhase 2
Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
China40 participantsStarted 2025-07-30
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* 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).
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 diseas…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free Survival as Assessed by RECIST v1.1
Timeframe: From enrollment to the end of treatment at 12 months
Trial details
NCT IDNCT07061535
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University