Extensive-Stage Small Cell Lung CancerNCT07885332
Real-World Use of Tarlatamab in Chinese Patients With Small-Cell Lung Cancer
An observational study of Extensive-Stage Small Cell Lung Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
This is an investigator-initiated, single-center, observational, noninterventional retrospective real-world cohort study evaluating the effectiveness and safety of tarlatamab as second-line or later-line therapy in Chinese adults with extensive-stage small-cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-Stage Small Cell Lung Cancer
- What is being tested?
- Tarlatamab
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2026to 30 Nov 2026
- Phase
- Observational
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Chinese patients with pathologically confirmed extensive-stage small-cell lung cancer who received tarlatamab in routine clinical practice after at least one prior systemic treatment regimen including platinum-based chemotherapy. Eligible patients were retrospectively identified from available medical records at the study center.
Who may be able to join
- Age ≥18 years.
- Pathologically confirmed extensive-stage small-cell lung cancer (ES-SCLC).
- Received tarlatamab after at least one prior systemic treatment regimen that included platinum-based chemotherapy.
- Documented exposure to tarlatamab in routine clinical practice.
- Available clinical information sufficient for evaluation of tumor response and safety outcomes.
Who cannot join
- No documented tarlatamab exposure.
- Insufficient clinical information for evaluation of tumor response and safety outcomes.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin-Hainan Hospital, Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)
Qionghai, Hainan, 571400
About this study
Official title: Real-World Effectiveness and Safety of Tarlatamab as Second-Line or Later-Line Therapy in Chinese Patients With Extensive-Stage Small-Cell Lung Cancer: A Single-Center Retrospective Cohort Study
This is an investigator-initiated, single-center, observational, noninterventional retrospective real-world cohort study evaluating the effectiveness and safety of tarlatamab as second-line or later-line therapy in Chinese adults with extensive-stage small-cell lung cancer. Clinical data are retrospectively collected from patients who received tarlatamab as part of routine clinical care. The primary outcome is overall objective response rate (ORR). Secondary outcomes include overall disease control rate (DCR) and the incidence and severity of adverse events, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Treatment with tarlatamab and supportive management was determined independently by treating physicians and was not assigned by the study protocol.
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Being tested
- Tarlatamab
- Keywords
- Tarlatamab, Small-cell lung cancer, Real-world study, Cytokine release syndrome
- Medical subject headings
- Small Cell Lung Carcinoma, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TarlatamabDrug
Tarlatamab was administered as part of routine clinical care. Treatment decisions, including tarlatamab administration, radiotherapy, and supportive management, were made independently by treating physicians and were not assigned by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Tarlatamab-Treated Cohort | Adult Chinese patients with extensive-stage small-cell lung cancer who received tarlatamab as second-line or later-line therapy in routine clinical practice. Receives: Drug: Tarlatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Objective Response Rate (ORR)
Overall ORR is defined as the proportion of patients with an evaluable overall tumor response whose best overall response is complete response (CR) or partial response (PR), based on clinician assessments documented during routine clinical care.
Measured: Up to 12 months after the first dose of tarlatamab.
Secondary outcomes (2)
Overall Disease Control Rate (DCR)
Overall DCR is defined as the proportion of patients with an evaluable overall tumor response whose best overall response is CR, PR, or stable disease (SD), based on clinician assessments documented during routine clinical care.
Measured: Up to 12 months after the first dose of tarlatamab.
Incidence and Severity of Adverse Events
The incidence and severity of adverse events during tarlatamab treatment are summarized based on available clinical records. Adverse events of special interest include cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), including their highest documented grades and the occurrence of Grade 3 or higher events.
Measured: From the first dose of tarlatamab through treatment discontinuation, up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start3 Aug 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885332
- Sponsor's protocol ID
- RWS2026-004
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) are not planned to be shared with external researchers because the study uses sensitive clinical data derived from medical records and follow-up. Study data are de-identified and managed under applicable confidentiality, privacy, and institutional data security requirements, with access restricted to authorized study personnel.