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

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.

Study Overview

• Status: Unknown
• Conditions: Small Cell Lung Cancer; PEG-rhG-CSF
• Intervention / Treatment: Drug: PEG-rhG-CSF

• Study Type: Interventional
• Enrollment (Anticipated): 61
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Zhao, PhD; Phone Number: 86-010-88196456; Email: ohjerry@163.com
• Study Contact Backup: Name: Hanxiao Chen; Phone Number: 18810526948; Email: Hanxiao0628@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Bejing Cancer Hospital
      • Contact: Jun Zhao, PhD; Phone Number: 86-010-88196456; Email: ohjerry@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PEG-rhG-CSF; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
• Collaborators: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: December 12, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 16, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: CSPC-JYL-SCLC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No