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

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03776604
• Other study ID #: CSPC-JYL-SCLC-01
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2018
• Est. completion date: February 2020

Study information

• Verified date: December 2018
• Source: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
• Contact: Jun Zhao, PhD
• Phone: 86-010-88196456
• Email: ohjerry[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: February 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Age = 70 years old, gender is not limited;

• Small cell lung cancer patients diagnosed by histopathology or cytology;

• ECOG = 0-1;

• The estimated survival period is more than 3 months;

• No obvious signs of hematological disease, defined as Hb=90g/dL, WBC=4.0×10^9/L, ANC=2×10^9/L, PLT=100×10^9/L before enrollment. And no bleeding tendency;

• No obvious abnormalities were observed in the electrocardiogram examination;

• Liver function tests ALT, AST, TBIL indicators are within 2.5 times the upper limit of normal values. If due to liver metastasis, the above indicators should be within 5 times of the upper limit of normal. If LDH is elevated due to non-tumor causes, LDH should be = 2.5 times the upper limit of normal; if LDH is elevated due to tumor, it can be enrolled;

• Renal function test BUN, UA within 1.5 times the upper limit of normal value, creatinine clearance rate> 60ml / min;

• Subjects (or their legal representatives/guardians) must sign an informed consent form indicating that they understand the purpose of the study, understand the necessary procedures for the study, and are willing to participate in the study.

Exclusion Criteria:

• There are currently uncontrollable infections, body temperature = 38.0 ° C;

• Patients with previous malignant tumors that have not been cured or have bone marrow metastasis;

• Patients with prophylactic antibiotics;

• Accepting other test drugs at the same time or participating in other clinical trials;

• Those who are allergic to this product or other genetically engineered E. coli-derived biological products;

• The patient has any myelodysplastic and other blood system diseases;

• Patients who have received hematopoietic stem cell transplantation or organ transplantation;

• The patient has a severe mental or neurological condition that affects informed consent and/or adverse reaction presentation or observation.

Related Conditions & MeSH terms

• Lung Neoplasms
• PEG-rhG-CSF
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	Bejing Cancer Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.	Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence and severity of adverse events	All adverse events will be recorded from the time of signing the informed consent form to 30 days after the last dose. Adverse events 30 days after the last dose, only those adverse events associated with the study drug were recorded.	through the study completion,an average of 3 months
Primary	The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.	The incidence of grade III/IV neutropenia in the first cycle of PEG-rhG-CSF.	through first cycle of PEG-rhG-CSF,an average of 1 month
Primary	The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.	The incidence of grade III/IV neutropenia in the second cycle of PEG-rhG-CSF.	through second cycle of PEG-rhG-CSF,an average of 1 month
Secondary	The incidence of febrile neutropenia in cycles 1 and 2	Febrile neutropenia (FN) is defined as oral temperature >38.3 ° C (underarm temperature >38.1 ° C) or continuous measurement of oral temperature >38 ° C (underarm temperature >37.8 ° C) in 2 h, and ANC <0.5×10^9/L, or expected to be <0.5×10^9/L	through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
Secondary	The ANC recovery time in cycles 1 and 2	Defined as the patients who appear ANC<2.0×10^9/L,from the first day of chemotherapy, to the time of ANC= 2.0×10^9/L, take the median.	through 1-2 cycles of PEG-rhG-CSF,an average of 2 month
Secondary	The incidence of infection		up to 30 days after the patient study completion
Secondary	The incidence of antibiotic use		up to 30 days after the patient study completion
Secondary	Incidence of chemotherapy dose adjustment due to neutropenia		through the study completion,an average of 3 months
Secondary	Chemotherapy delay time		through the study completion,an average of 3 months
Secondary	Incidence of chemotherapy delay caused by neutropenia		through the study completion,an average of 3 months
Secondary	The duration of febrile neutropenia in cycles 1 and 2		through 1-2 cycles of PEG-rhG-CSF,an average of 2 month