Real-World Study of Toripalimab in Extensive-Stage Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFudan University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Treatments tested in this trial
- Toripalimab
Treatment groups
1,200 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov