A Prospective, Observational, Multi-Center, Real-World Study of Toripalimab Injection in First-Line Treatment of Extensive-Stage Small Cell Lung Cancer
| Registry | NCT07308379 |
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| Status | Not yet recruiting |
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| Study type | Observational |
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| Enrollment | 1200 (Estimated) |
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| Sponsor | Fudan University (Other) |
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| Conditions | SCLC, Extensive Stage, Toripalimab |
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| Interventions | Toripalimab (Drug) |
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| Dates | start 2026-02-01 (estimated), primary completion 2028-02-01 (estimated), completion 2028-08-01 (estimated), first posted 2025-12-29, last updated 2025-12-29 |
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All trials for SCLC, Extensive Stage All trials for Toripalimab All trials of Toripalimab
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Toripalimab group | | Drug: Toripalimab | |
- Toripalimab (Drug): A humanized IgG4 monoclonal antibody against programmed cell death protein 1 (PD-1). The recommended dosage is 240 mg administered intravenously on Day 1 of each 3-week cycle (q3w). Treatment continues until disease progression, unacceptable toxicity, death, withdrawal of consent, or investigator decision. It is used in combination with chemotherapy (etoposide and platinum-based drugs) as per routine clinical practice.
+Outcome measures
Primary outcomes
- Real-world Progression-Free Survival (rwPFS) [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]: 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.
- Real-world Objective Response Rate (rwORR) [2 years]: The proportion of patients who achieve a Complete Response (CR) or Partial Response (PR); response is determined by the investigator based on clinician-cited evidence or records without a source of evidence.
- Real-world Disease Control Rate (rwDCR) [2 years]: The proportion of patients who achieve a Complete Response (CR) or Partial Response (PR) or Stable Disease (SD); response is determined by the investigator based on clinician-cited evidence or records without a source of evidence.
- Treatment-related adverse event (TRAE) [2 years]: Including immune-related adverse events (irAEs), particularly Grade ≥3 TRAEs. Monitoring for adverse events will be conducted during the treatment period and until 30 days after the last dose, or until the event resolves or stabilizes.
+Eligibility
Sex: All
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.