Real-World Study of Toripalimab in Extensive-Stage Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Toripalimab.
- Who it may be relevant to
- Registry conditions: SCLC, Extensive Stage, Toripalimab. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Observational, Multi-Center, Real-World Study of Toripalimab Injection in First-Line Treatment of Extensive-Stage Small Cell Lung Cancer
Overview
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.
Interventions
- Drug Toripalimab
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.
Primary outcome measures
- Real-world Progression-Free Survival (rwPFS) [Time frame: 2 years]
Secondary outcome measures (4)
- Real-world Overall Survival (rwOS) [Time frame: 2 years]
- Real-world Objective Response Rate (rwORR) [Time frame: 2 years]
- Real-world Disease Control Rate (rwDCR) [Time frame: 2 years]
- Treatment-related adverse event (TRAE) [Time frame: 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07308379 · ES-SCLC-01