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

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

Trial Details

NCT ID
NCT07061535
Phase
PHASE2
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Tafolecimab
  • Sintilimab (approved)
  • Etoposide
  • Carboplatin / Cisplatin
Locations (sample)
  • Changsha, Hunan, China|28.19874,112.97087
  • Jinan, Shandong, China|36.66833,116.99722
  • Hangzhou, Zhejiang, China|30.29365,120.16142
  • Hangzhou, Zhejiang, China|30.29365,120.16142
  • Hangzhou, Zhejiang, China|30.29365,120.16142

Key Eligibility 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 cr…
  • Previously not receiving systemic treatment for ES-SCLC;
  • Greater than or equal to 1 measurable lesion exists according to RECIST v1.1;

For full eligibility, visit ClinicalTrials.gov.

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