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

NCT ID: NCT07308379

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-28

Study Completion Date

2028-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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SCLC, Extensive Stage Toripalimab

Keywords

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Extensive stage SCLC Toripalimab Real-World Study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Toripalimab group

Toripalimab

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Zhengfei Zhu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Zhengfei Zhu, PhD

Role: CONTACT

Phone: +8618017312901

Email: [email protected]

Other Identifiers

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ES-SCLC-01

Identifier Type: -

Identifier Source: org_study_id