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

NCT03776604 | Unknown DMC

• 1 other identifier: CSPC-JYL-SCLC-01
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• The incidence of febrile neutropenia in cycles 1 and 2

  through 1-2 cycles of PEG-rhG-CSF,an average of 2 month

• The ANC recovery time in cycles 1 and 2

  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

Other Outcomes (1)

• Incidence and severity of adverse events

  through the study completion,an average of 3 months

Study Arms (1)

PEG-rhG-CSF

EXPERIMENTAL

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

Interventions

PEG-rhG-CSF DRUG

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.

PEG-rhG-CSF

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Bejing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jun Zhao, PhD

CONTACT

86-010-88196456; ohjerry@163.com

Hanxiao Chen

CONTACT

18810526948; Hanxiao0628@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 17, 2018
• Study Start: December 5, 2018
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

CN (1)