Multicenter retrospective study evaluating the efficacy and safety of G-CSF primary prophylaxis in small cell lung cancer patients treated with first-line platinum-etoposide and a PD-L1 inhibitor. TORG-TG2504

Multicenter retrospective study evaluating the efficacy and safety of G-CSF primary prophylaxis in small cell lung cancer patients treated with first-line platinum-etoposide and a PD-L1 inhibitor. TORG-TG2504 - Retrospective study evaluating the efficacy and safety of G-CSF primary prophylaxis in the first-line treatment of small cell lung cancer. TORG-TG2504

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000058266

Enrollment

250

Registered

2025-06-24

Start date

2025-06-24

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed with small cell lung cancer by histological or cytological examination. 2) Patients with extensive-stage small cell lung cancer, or patients who experienced recurrence after chemoradiotherapy for limited-stage small cell lung cancer. 3) Patients who received first-line treatment with one of the following regimens between September 1, 2019 and December 31, 2023 ????arboplatin/etoposide/atezolizumab ????arboplatin/etoposide/durvalumab ????isplatin/etoposide/durvalumab 4)Patients who received the first cycle of first-line treatment with ????arboplatin at AUC over 5 ????isplatin at over 75 mg/m2 ????toposide at over 80 mg/m2 5)Patients aged 18 years or older at the start of treatment.

Exclusion criteria

Exclusion criteria: 1) Patients deemed inappropriate for inclusion in the study by the site investigator responsible for data collection. 2) Patients who refused to participate in this study via the opt-out process.

Design outcomes

Primary

Measure	Time frame
"To compare the incidence of febrile neutropenia (FN) with and without primary prophylaxis using G-CSF, point estimates will be calculated after applying inverse probability weighting. Between-group comparisons will be conducted using weighted logistic regression analysis. Robust variance estimation will be employed to estimate the variance of the odds ratios. For the cohort after propensity score matching, between-group comparisons will be performed using the chi-square test.	—

Measure

Time frame

"To compare the incidence of febrile neutropenia (FN) with and without primary prophylaxis using G-CSF, point estimates will be calculated after applying inverse probability weighting. Between-group comparisons will be conducted using weighted logistic regression analysis. Robust variance estimation will be employed to estimate the variance of the odds ratios. For the cohort after propensity score matching, between-group comparisons will be performed using the chi-square test.

—

Secondary

Measure	Time frame
Mortality, unscheduled outpatient visit rate, emergency hospitalization rate related to febrile neutropenia. Overall survival. Progression-free survival. Objective response rate. Mean relative dose intensity. Incidence of adverse events.	—

Countries

Japan

Contacts

Public ContactShuhei Teranishi

Kanagawa Cancer Center Department of Thoracic Oncology

teranishi.shu.su@yokohama-cu.ac.jp0455202222

Outcome results