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NCT07308379Not yet recruiting

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

A Prospective, Observational, Multi-Center, Real-World Study of Toripalimab Injection in First-Line Treatment of Extensive-Stage Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 29 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
1200 (estimated)
First submitted
15 Dec 2025
Start date
Feb 2026
Primary completion date
Feb 2028
Lead sponsor
Fudan University
NCT number
NCT07308379

What you commit to

  • Study type: Observational
  • Planned participants: 1200
  • From Feb 2026 to the primary completion date, Feb 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Known allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs or their components;
  • Any other condition deemed by the investigator as unsuitable for inclusion in the study.

Other

  • Pregnant or lactating women;

Who the study is looking for

  • Voluntarily participate and sign the informed consent form.
  • Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC);
  • Scheduled to receive Toripalimab as first-line treatment;
  • Availability of traceable medical history records during the treatment period.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.