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

Fudan University

Status: Not yet enrolling

Conditions: Toripalimab; SCLC, Extensive Stage

Treatments: Drug: Toripalimab

Study type: Observational

Funder types: Other

Identifiers

NCT07308379

ES-SCLC-01

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Pregnant or lactating women;
• 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.

Trial design

1,200 participants in 1 patient group

Toripalimab group

Treatment:

Drug: Toripalimab