NCT03776604

PEG-rhG-CSF in Elderly Patients With Small Cell Lung Cancer Receiving Chemotherapy

Multi-center, Open, One-arm Clinical Study Evaluating the Efficacy and Safety of Jinyouli (PEGylated Recombinant Human Granulocyte Stimulating Factor, PEG-rhG-CSF) in Preventing Neutropenia After Chemotherapy in Elderly Patients With Small Cell Lung Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (estimated)
• Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the efficacy and safety of Jinyouli in preventing neutropenia in multiple chemotherapy cycles in elderly patients with small cell lung cancer through a multicenter, open, one-arm study Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria, chemotherapy regimen: etoposide: 100 mg/m2, d1-3, carboplatin: AUC=5, d1, q21d, prophylactic use test 48 h after chemotherapy Drug PEG-rhG-CSF.

Conditions

• Small Cell Lung Cancer
• PEG-rhG-CSF

Interventions

Type	Name	Description
DRUG	PEG-rhG-CSF	Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria were prophylactically administered the test drug PEG-rhG-CSF 48 h after chemotherapy. Jin Youli（PEG-rhG-CSF）: The dose is determined according to the patient's weight. Those who weighed more than ≥45kg were given 6mg/time, and those who were \<45kg or less were given 3mg/time. Administration method: Subcutaneous injection, the lower edge of the deltoid muscle of both arms is preferentially selected, and each injection is injected once every chemotherapy cycle. Dosing time: 48 h after chemotherapy.

Timeline

• Start date: 2018-12-05
• Primary completion: 2019-12-01
• Completion: 2020-02-01
• First posted: 2018-12-17
• Last updated: 2018-12-19

Locations

1 site across 1 country: China