RecruitingPhase IIEN originalLung cancerMetastatic / advanced

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the 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).

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek co najmniej 18 lat, ogólny stan zdrowia pozwalający na leczenie (skala 0-1)
  • •Potwierdzony rozpoznaniem zaawansowany rak płuc z małymi komórkami
  • •Dotychczas bez wcześniejszego leczenia systemowego tego raka
  • •Co najmniej jeden guz do zmierzenia wg standardowych kryteriów
  • •Spodziewana przeżywalność co najmniej 12 tygodni
  • •Prawidłowa funkcja narządów wewnętrznych

✗ Disqualifies

  • •Poprzednie leczenie systemowe raka płuc z małymi komórkami
  • •Mieszany typ raka lub transformacja do innego rodzaju
  • •Uczestnietwo w innym badaniu klinicznym w ostatnich 4 tygodniach
  • •Aktywne przerzuty w mózgu powodujące objawy
  • •Poważne choroby sercowo-naczyniowe
  • •Aktywne zapalenie wątroby lub HIV
  • •Czynne choroby autoimmunologiczne lub niekontrolowane choroby
  • •Ciąża lub karmienie piersią

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
September 15, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (5)

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

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/16/2026.

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