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Multicenter Prospective Observational Study on the Efficacy and Safety of Tarlatamab in Relapsed Extended-stage Small-Cell Lung Cancer (T-REX study)

Multicenter Prospective Observational Study on the Efficacy and Safety of Tarlatamab in Relapsed Extended-stage Small-Cell Lung Cancer - Multicenter Prospective Observational Study on the Efficacy and Safety of Tarlatamab in Relapsed Extended-stage Small-Cell Lung Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000057253
Enrollment
110
Registered
2025-04-23
Start date
2025-04-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Cancer

Interventions

None listed

Sponsors

Kyoto Prefectural University of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Aged 18 years or older at the time of consent with a performance status of 0-3. Recurrent small-cell lung cancer, regardless of the number of prior treatment lines. At least one evaluable lesion according to RECIST version 1.1. Scheduled to receive tarlatamab therapy. Patients who have received a thorough explanation of this clinical study and have provided written informed consent voluntarily.

Exclusion criteria

Exclusion criteria: Patients deemed inappropriate by the attending physician.

Design outcomes

Primary

MeasureTime frame
Objective response rate

Secondary

MeasureTime frame
Disease control rate, progression-free survival, time to treatment failure, overall survival, and safety of tarlatamab therapy; improvement in performance status Efficacy and safety of tarlatamab therapy for central nervous system lesions Association between the efficacy and safety of tarlatamab therapy and patient characteristics Association between the efficacy and safety of tarlatamab therapy and cancer cachexia Association between the efficacy and safety of tarlatamab therapy and the treatment line Association between the efficacy and safety of tarlatamab therapy and eligibility for clinical trial criteria Association of the efficacy and safety of tarlatamab therapy with gut microbiota composition and diversity, as well as tumor immune microenvironment factors

Countries

Japan

Contacts

Public ContactHayato Kawachi

Kyoto Prefectural University of Medicine Department of Graduate School of Medicine, Respiratory Medicine,

kwhat@koto.kpu-m.ac.jp075-251-5513

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026