A Study of Efbemalenograstim Alfa Injection for Stage IIIB or IV NSCLC Recieving Moderate-risk Febrile Neutropenia (FN) Chemotherapy Regimen With Risk Factors
NCT ID: NCT06143735
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
99 participants
INTERVENTIONAL
2023-12-31
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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experimental group（primary prevention）
Efgbemalenograstim alfa, 20 mg, subcutaneous injection, administered 48±4 hours after the completion of each chemotherapy cycle.
Efgbemalenograstim alfa
Efbemalenograstim alfa Injection is a recombinant fusion protein composed of the double molecules of human granulocyte colony-stimulating factor (G-CSF) and the Fc fragment of human immunoglobulin (hIgG2). It is used for adult patients with non-myeloid malignancies undergoing myelosuppressive anticancer therapy that is associated with a high risk of febrile neutropenia, to reduce the incidence of infections manifested by febrile neutropenia.
control group（secondary prevention）
Efgbemalenograstim alfa, 20 mg, subcutaneous injection, administered 48±4 hours after the completion of the next chemotherapy cycle if ≥ Grade 3 ANC reduction occurs in the preceding chemotherapy cycle.
Efgbemalenograstim alfa
Efbemalenograstim alfa Injection is a recombinant fusion protein composed of the double molecules of human granulocyte colony-stimulating factor (G-CSF) and the Fc fragment of human immunoglobulin (hIgG2). It is used for adult patients with non-myeloid malignancies undergoing myelosuppressive anticancer therapy that is associated with a high risk of febrile neutropenia, to reduce the incidence of infections manifested by febrile neutropenia.
Interventions
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Efgbemalenograstim alfa
Efbemalenograstim alfa Injection is a recombinant fusion protein composed of the double molecules of human granulocyte colony-stimulating factor (G-CSF) and the Fc fragment of human immunoglobulin (hIgG2). It is used for adult patients with non-myeloid malignancies undergoing myelosuppressive anticancer therapy that is associated with a high risk of febrile neutropenia, to reduce the incidence of infections manifested by febrile neutropenia.
Eligibility Criteria
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Inclusion Criteria
2. At the time of signing the informed consent form, participants must be ≥ 18 years old, with no gender restrictions.
3. Stage IIIB-IV NSCLC with negative driver mutations, who have not received chemotherapy or radiotherapy previously.
4. Planned to undergo platinum-based (carboplatin/cisplatin) combined with taxane-based (paclitaxel/albumin-bound paclitaxel/liposomal paclitaxel/paclitaxel polymer micelles) chemotherapy regimen (may be combined with immunotherapy or anti-angiogenic therapy).
5. Have other risk factors related to febrile neutropenia (FN), including but not limited to age ≥65 years, poor nutritional/physical condition (i.e., ECOG score ≥2), etc.
6. Expected survival of at least 12 weeks.
7. Normal function of major organs, meeting the following criteria:
* Complete blood count criteria (no blood transfusion in the past 14 days, no use of G-CSF or other hematopoietic growth factors for correction):
* Hemoglobin (Hb) ≥ 90g/L
* Absolute neutrophil count (ANC) ≥ 2.0×10\^9/L
* Platelets (PLT) ≥ 80×10\^9/L
* Biochemical criteria:
* Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN
* Serum creatinine (Cr) ≤ 1.5 ULN or creatinine clearance rate (CrCl) ≥ 50 ml/min
8. Women of childbearing potential must have implemented reliable contraceptive measures or undergone a serum pregnancy test within 7 days before enrollment, with a negative result.
9. Male and female participants of childbearing age must agree to use reliable contraceptive methods from before entering the trial, throughout the study, and for 8 weeks after discontinuation.
Exclusion Criteria
2. Underwent bone marrow transplantation or stem cell transplantation.
3. Concurrently diagnosed with malignancies other than NSCLC.
4. Active central nervous system metastasis and/or carcinomatous meningitis, except for asymptomatic brain metastasis subjects (i.e., no progressive central nervous system symptoms caused by brain metastases, no need for corticosteroids, and lesion size ≤1.5 cm) are allowed.
5. Diagnosed with acute congestive heart failure, cardiomyopathy, or myocardial infarction by clinical, electrocardiogram, or other means.
6. Has a disease that may cause splenomegaly.
7. Associated with malignant hematological disorders.
8. Previously experienced sustained Grade ≥3 neutropenia (ANC \<1.0×10\^9/L) or febrile neutropenia lasting 3 days or more.
9. Underwent surgical procedures within the past 4 weeks and/or has an open wound.
10. Tumor involvement in the bone marrow.
11. Diagnosed with acute infections, chronic active hepatitis B within the past year (unless known negative for hepatitis B virus antigen before selection), or hepatitis C.
12. Pregnant or lactating women.
13. Known positive serum response to human immunodeficiency virus (HIV) or diagnosed with AIDS.
14. Active tuberculosis or recent history of contact with a tuberculosis patient unless tuberculin test is negative; or receiving treatment for tuberculosis; or suspected cases on chest X-ray.
15. Sickle cell anemia.
16. Known allergy to granulocyte colony-stimulating factors or drug excipients.
17. Rubber allergy.
18. Use of other investigational drugs within the past month before enrollment.
19. The investigator believes the participant has a disease or symptoms that make them unsuitable for participation in this study, and the investigational drug may harm the participant's health or affect the judgment of adverse events.
18 Years
85 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Locations
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Henan Provincial People's Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
the First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shandong Cancer Hospital & Institute
Jinan, Shandong, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Ningbo No.2 Hospital
Ningbo, Zhejiang, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Tianhui Gao
Role: primary
Caixia Liu
Role: primary
Wei Zheng
Role: primary
Huangming Hong
Role: primary
Haitao Lan
Role: primary
Chuangzhou Rao
Role: primary
Dingzhi Huang
Role: primary
Other Identifiers
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GUARD-03
Identifier Type: -
Identifier Source: org_study_id