A Study of Efbemalenograstim Alfa Injection for Stage IIIB or IV NSCLC Recieving Moderate-risk Febrile Neutropenia (FN) Chemotherapy Regimen With Risk Factors

Non Small Cell Lung Cancer Clinical Trial

Official title:

A Randomized, Multicenter, Exploratory Clinical Study for The Primary And Secondary Prevention of Febrile Neutropenia (FN) With Efbemalenograstim Alfa in Patients With Non-small Cell Lung Cancer (NSCLC) at Moderate Risk Undergoing Chemotherapy Regimens With Associated Risk Factors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06143735
• Other study ID #: GUARD-03
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 31, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2023
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Dingzhi Huang
• Phone: +86-22-23340123-1031
• Email: dingzhih72[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to observe the efficacy and safety of Efbemalenograstim Alfa in the prevention of absolute neutrophil count (ANC) reduction after chemotherapy in NSCLC patients at risk of platinum-containing chemotherapy with risk factors in febrile neutropenia (FN)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 99
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Participants voluntarily join this study, sign an informed consent form, exhibit good compliance, and cooperate with follow-up.

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:

1. Previously received chemotherapy or radiotherapy, including but not limited to neoadjuvant chemoradiotherapy and/or adjuvant chemoradiotherapy.

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Febrile Neutropenia
• Lung Neoplasms
• Neutropenia
• Non Small Cell Lung Cancer

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Sichuan Cancer Hospital	Chengdu	Sichuan
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia
China	Shandong Cancer Hospital & Institute	Jinan	Shandong
China	Ningbo No.2 Hospital	Ningbo	Zhejiang
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	the First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence rate of Grade =3 ANC reduction	The incidence rate of Grade =3 ANC reduction during the first chemotherapy cycle for two groups of participants receiving primary and secondary prophylaxis with Efgbemalenograstim alfa in the first treatment cycle.	Up to a year and a half after starting chemotherapy
Secondary	The incidence rate of FN	The incidence rate of febrile neutropenia (FN) for each cycle	Up to a year and a half after starting chemotherapy
Secondary	The incidence rate of Grade =3 ANC reduction	The incidence rate of Grade =3 ANC reduction during chemotherapy cycles 2-4/6	Up to a year and a half after starting chemotherapy
Secondary	Adverse Events	Including adverse events/serious adverse events and their incidence rates	Up to a year and a half after starting chemotherapy