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

NCT07061535 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-11

No results posted yet for this study

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).

Conditions

  • Extensive-stage Small Cell Lung Cancer (ES-SCLC)
  • Extensive Stage Lung Small Cell Cancer
  • Extensive-Stage Small-Cell Lung Cancer
  • Extensive Disease Small Cell Lung Cancer

Interventions

DRUG

Tafolecimab

Patients will receive Tafolecimab 300 mg every 3 weeks.

DRUG

Sintilimab (approved)

Patients will receive Sintilimab 200 mg every 3 weeks.

DRUG

Etoposide

Patients will recieve Etoposide (100 mg/m2) intravenously on days 1, 2, and 3 of each 3-week cycle.

DRUG

Carboplatin / Cisplatin

Patients will receive carboplatin (AUC 5 mg/mL/min) or cisplatin (75 mg/m2) intravenously on day 1 of each 3-week cycle for up to 4 to 6 cycles.

Sponsors & Collaborators

  • Innovent Biologics, Inc.

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2027-08-01
Completion
2027-08-01

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07061535 on ClinicalTrials.gov