Efficacy and safety of primary prophylactic granulocyte-colony stimulating factor for patients with small cell lung cancer receiving chemotherapy and immunotherapy

Efficacy and safety of primary prophylactic granulocyte-colony stimulating factor for patients with small cell lung cancer receiving chemotherapy and immunotherapy -a pilot study-

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1061240128

Enrollment

Registered

2025-03-03

Start date

2025-03-25

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

Pegfilgrastim will be administered subcutaneously at a dose of 3.6mg from the 1st course to the 4th course of chemotherapy and immunotherapy.

C455861

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Over 18 years old 2. Witten informed consent 3. Patients with small cell lung cancer 4. Patients who are planned to receive chemotherapy and immunotherapy 5. Patients with laboratory data which meet the following criteria - Absolute neutrophil count >= 1500 cells/mm^3 - Platelet count >= 100,000 cells/mm^3 - Hemoglobin >= 8.5 g/dL - AST and ALT = 45 mL/min - SpO2 (room air) >= 90% or PaO2 >= 60Torr 6. ECOG PS 0-2

Exclusion criteria

Exclusion criteria: 1. Patients with hypersensitivity to G-CSF 2. Patients with active overlapping cancers 3. Patients who are pregnant or lactating 4. Patients judged by the principal investigator or co-investigator to be inappropriate for this study

Design outcomes

Primary

Measure	Time frame
Ratio of cases with febrile neutropenia	—

Secondary

Measure	Time frame
1. Ratio of cases with infections (excluding chronic infections such as tinea) 2. Ratio of cases with Grade 3 or higher neutropenia 3. Ratio of cases with bone pain and other adverse events associated with G-CSF 4. Quality of life (EORTC QLQ-C30) 5. Length of hospital stay for initial treatment for small cell lung cancer 6. Objective response rate	—

Contacts

Public ContactNoriaki Ito

Hiroshima University Hospital

d223951@hiroshima-u.ac.jp+81-82-257-5196

Outcome results

None listed

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