Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| SCLC, Extensive Stage | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Toripalimab | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Toripalimab group
- interventionNames
- Drug: Toripalimab
Primary outcomes (1)
- measure
- Real-world Progression-Free Survival (rwPFS)
- timeFrame
- 2 years
- description
- 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 (4)
- measure
- Real-world Overall Survival (rwOS)
- timeFrame
- 2 years
- description
- The time from the initiation of the first dose until the documented event of death from any cause. Patients who do not experience the event will be censored at the date of their last known survival. Patients who do not provide any follow-up information will be censored on the date of enrollment/initiation of medication.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available