Real-World Use of Tarlatamab in Chinese Patients With Small-Cell Lung Cancer

NCT07885332 | Active Not Recruiting FDA Drug

• 1 other identifier: RWS2026-004
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Tarlatamab; Small-cell lung cancer; Real-world study; Cytokine release syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 12 months after the first dose of tarlatamab.

Secondary Outcomes (2)

• Overall Disease Control Rate (DCR)

  Up to 12 months after the first dose of tarlatamab.

• Incidence and Severity of Adverse Events

  From the first dose of tarlatamab through treatment discontinuation, up to 12 months.

Study Arms (1)

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.

Drug: Tarlatamab

Interventions

Tarlatamab DRUG

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.

Tarlatamab-Treated Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• No documented tarlatamab exposure.
• Insufficient clinical information for evaluation of tumor response and safety outcomes.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine: collaborator

Study Sites (1)

Ruijin-Hainan Hospital, Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)

Qionghai, Hainan, 571400, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 21, 2026
• Study Start: August 3, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: October 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)