Real-World Study of Toripalimab in Extensive-Stage Small Cell Lung Cancer

NCT07308379 | Not Yet Recruiting

• 1 other identifier: ES-SCLC-01
• Study Type: observational
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

SCLC, Extensive Stage; Toripalimab

Keywords

Extensive stage SCLC; Toripalimab; Real-World Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Toripalimab group

Drug: Toripalimab

Interventions

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.

Toripalimab group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or lactating women;
• Known allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs or their components；

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Interventions

toripalimab

Central Study Contacts

Zhengfei Zhu, PhD

CONTACT

+8618017312901; fuscczzf@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-12