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

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 Overview

• Status: Not yet recruiting
• Conditions: SCLC, Extensive Stage; Toripalimab
• Intervention / Treatment: Drug: Toripalimab

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Zhengfei Zhu, PhD; Phone Number: +8618017312901; Email: fuscczzf@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients are collected in several hospitals in shanghai, China, diagnosed with extensive-stage small cell lung cancer (ES-SCLC)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Toripalimab group

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real-world Progression-Free Survival (rwPFS)	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real-world Overall Survival (rwOS)	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.	2 years
Real-world Objective Response Rate (rwORR)	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.	2 years
Real-world Disease Control Rate (rwDCR)	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.	2 years
Treatment-related adverse event (TRAE)	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.	2 years

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Toripalimab; Real-World Study; Extensive stage SCLC
• Additional Relevant MeSH Terms: toripalimab
• Other Study ID Numbers: ES-SCLC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No