A Prospective, Observational, Multi-Center, Real-World Study of Toripalimab Injection in First-Line Treatment of Extensive-Stage Small Cell Lung Cancer
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Fudan University
- Enrollment
- 1,200
- Primary Endpoint
- Real-world Progression-Free Survival (rwPFS)
Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Toripalimab group
Intervention: Toripalimab (Drug)
Outcomes
Primary Outcomes
Real-world Progression-Free Survival (rwPFS)
Time Frame: 2 years
The time from the initiation of the first dose until the first documented occurrence of disease progression or death from any cause, whichever occurs first. Patients who do not experience any event during follow-up or study treatment will be censored at the time of their last tumor assessment. Patients who do not have any post-baseline assessment will be censored on the date of enrollment/initiation of medication.
Secondary Outcomes
- Real-world Overall Survival (rwOS)(2 years)
- Real-world Objective Response Rate (rwORR)(2 years)
- Real-world Disease Control Rate (rwDCR)(2 years)
- Treatment-related adverse event (TRAE)(2 years)
Investigators
Zhengfei Zhu
Professor
Fudan University