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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Small Cell Lung Cancer, PEG-rhG-CSF

Intervention / Treatment
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* Drug: PEG-rhG-CSF


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-rhG-CSF<br>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. | Drug: PEG-rhG-CSF<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| The incidence of infection |  | up to 30 days after the patient study completion | 
| The incidence of antibiotic use |  | up to 30 days after the patient study completion | 
| Incidence of chemotherapy dose adjustment due to neutropenia |  | through the study completion,an average of 3 months | 
| Chemotherapy delay time |  | through the study completion,an average of 3 months | 
| Incidence of chemotherapy delay caused by neutropenia |  | through the study completion,an average of 3 months | 
| The duration of febrile neutropenia in cycles 1 and 2 |  | through 1-2 cycles of PEG-rhG-CSF,an average of 2 month |