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Real-World Study of Toripalimab in Extensive-Stage Small Cell Lung Cancer

NCT07308379 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2025-12-29

No results posted yet for this study

Summary

This is a prospective, observational, multi-center, real-world study evaluating the effectiveness and safety of Toripalimab (a PD-1 inhibitor) as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). The primary objective is to assess real-world progression-free survival (rwPFS). Secondary objectives include evaluating real-world objective response rate (rwORR), disease control rate (rwDCR), overall survival (rwOS), and safety. Approximately 1200 patients from multiple centers in China will be enrolled and followed according to routine clinical practice. Data will be collected from medical records and follow-up visits.

Conditions

  • SCLC, Extensive Stage
  • Toripalimab

Interventions

DRUG

Toripalimab

A humanized IgG4 monoclonal antibody against programmed cell death protein 1 (PD-1). The recommended dosage is 240 mg administered intravenously on Day 1 of each 3-week cycle (q3w). Treatment continues until disease progression, unacceptable toxicity, death, withdrawal of consent, or investigator decision. It is used in combination with chemotherapy (etoposide and platinum-based drugs) as per routine clinical practice.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2028-02-29
Completion
2028-08-31

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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 NCT07308379 on ClinicalTrials.gov