SCLC, Extensive StageNCT07308379
Real-World Study of Toripalimab in Extensive-Stage Small Cell Lung Cancer
An observational study of SCLC, Extensive Stage and Toripalimab, run by Fudan University.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- SCLC, Extensive Stage, Toripalimab
- What is being tested?
- Toripalimab
- Type of treatment
- Injection or infusion
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients are collected in several hospitals in shanghai, China, diagnosed with extensive-stage small cell lung cancer (ES-SCLC)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- SCLC, Extensive Stage, Toripalimab
- Being tested
- Toripalimab
- Keywords
- Extensive stage SCLC, Toripalimab, Real-World Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab group | Not described Receives: Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study startFeb 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCLC, Extensive StageStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengfei Zhu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308379
- Sponsor's protocol ID
- ES-SCLC-01
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Multi-Center, Real-World Study of Toripalimab Injection in First-Line Treatment of Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07308379
- Acronym / sponsor ID
- ES-SCLC-01
- Conditions
- SCLC, Extensive Stage, Toripalimab
- Keywords
- Extensive stage SCLC, Toripalimab, Real-World Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab group | – | Drug: Toripalimab |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients are collected in several hospitals in shanghai, China, diagnosed with extensive-stage small cell lung cancer (ES-SCLC)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ToripalimabA 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. | Drug | Toripalimab group |
Primary outcome
Real-world Progression-Free Survival (rwPFS)
Time frame: 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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
Related trials for SCLC, Extensive Stage
Active, not recruitingPhase 3
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
Extensive-Stage Small-Cell Lung Cancer, Small-Cell Lung Cancer
RecruitingPhase 2
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Extensive-stage Small-cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
RecruitingPhase 2
MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer
Small Cell Lung Cancer, SCLC
Not yet recruitingPhase 2
Low-Dose Radiotherapy Plus Adebrelimab and Chemotherapy for Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of SCLC, Extensive Stage and Toripalimab, run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhengfei Zhu, PhD (+8618017312901, fuscczzf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-world Progression-Free Survival (rwPFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.