An observational study in Extensive-Stage Small Cell Lung Cancer, sponsored by Ruijin Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Ruijin Hospital · Observational
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.
1,234 studies on the registry are indexed under Small Cell Lung Carcinoma; 350 are open to participants now.
This study's enrollment of 26 is below the median of 150 across 124 observational studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Ruijin Hospital is the lead sponsor of 667 studies on the registry; 376 are open to participants now.
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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.
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Exclusion Criteria:
Adult Chinese patients with extensive-stage small-cell lung cancer who received tarlatamab as second-line or later-line therapy in routine clinical practice.
Drug: Tarlatamab
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.
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.
Time frame: Up to 12 months after the first dose of tarlatamab.
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.
Time frame: 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.
Time frame: From the first dose of tarlatamab through treatment discontinuation, up to 12 months.
Plan to share: 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.
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Nov 2026, 3 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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