Clinical Trial: Prospective Observational Study on Predictive Factors for the Onset and Severity of Cytokine Release Syndrome in Small Cell Lung Cancer Patients Treated with Tarlatamab (Japan)

Tokyo, July 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062128) titled 'Prospective Observational Study on Predictive Factors for the Onset and Severity of Cytokine Release Syndrome in Small Cell Lung Cancer Patients Treated with Tarlatamab' on July 2.

Study Type: Observational

Primary Sponsor: Institute - Kanagawa Cancer Center

Condition: Condition - small cell lung cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to identify predictive factors associated with the onset and severity of cytokine release syndrome (CRS) in small cell lung cancer patients treated with tarlatamab. A comprehensive analysis of 93 cytokines and clinical background factors will be conducted to explore a predictive model for CRS. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Patients diagnosed with small cell lung cancer by histology or cytology 2) Patients with extensive-stage SCLC or relapsed limited-stage SCLC after prior treatment 3) Patients scheduled to receive tarlatamab between the date of approval and December 31, 2027 4) Aged 18 years or older at the time of consent 5) Provided written informed consent after receiving a full explanation of the study Key exclusion criteria - 1) Patients with a body temperature of 38 degrees Celsius or higher at the time of consent 2) Pregnant or breastfeeding patients 3) Patients deemed inappropriate for study participation by the principal or sub-investigator due to severe psychiatric disorders, communication difficulties, or inability to provide informed consent Target Size - 36

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 11 Month 14 Day Date of IRB - 2025 Year 12 Month 01 Day Anticipated trial start date - 2025 Year 12 Month 01 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071078

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