Non Small Cell Lung CancerPhase 2NCT06143735
A Study of Efbemalenograstim Alfa Injection for Stage IIIB or IV NSCLC Recieving Moderate-risk Febrile Neutropenia (FN) Chemotherapy Regimen With Risk Factors
A Phase 2 study testing Efgbemalenograstim alfa in people with Non Small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 10 sites in China.
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) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Efgbemalenograstim alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 10 sitesChina
- Study dates
- 31 Dec 2023to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants voluntarily join this study, sign an informed consent form, exhibit good compliance, and cooperate with follow-up.
- At the time of signing the informed consent form, participants must be ≥ 18 years old, with no gender restrictions.
- Stage IIIB-IV NSCLC with negative driver mutations, who have not received chemotherapy or radiotherapy previously.
- 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).
- 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.
- Expected survival of at least 12 weeks.
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- 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
- 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.
- 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.
Who cannot join
- Previously received chemotherapy or radiotherapy, including but not limited to neoadjuvant chemoradiotherapy and/or adjuvant chemoradiotherapy.
- Underwent bone marrow transplantation or stem cell transplantation.
- Concurrently diagnosed with malignancies other than NSCLC.
- 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.
- Diagnosed with acute congestive heart failure, cardiomyopathy, or myocardial infarction by clinical, electrocardiogram, or other means.
- Has a disease that may cause splenomegaly.
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- Associated with malignant hematological disorders.
- Previously experienced sustained Grade ≥3 neutropenia (ANC <1.0×10^9/L) or febrile neutropenia lasting 3 days or more.
- Underwent surgical procedures within the past 4 weeks and/or has an open wound.
- Tumor involvement in the bone marrow.
- 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.
- Pregnant or lactating women.
- Known positive serum response to human immunodeficiency virus (HIV) or diagnosed with AIDS.
- 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.
- Sickle cell anemia.
- Known allergy to granulocyte colony-stimulating factors or drug excipients.
- Rubber allergy.
- Use of other investigational drugs within the past month before enrollment.
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Sichuan Cancer Hospital
Chengdu, Sichuan
Huangming Hong
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Haitao Lan
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia
Caixia Liu
Shandong Cancer Hospital & Institute
Jinan, Shandong
Ningbo No.2 Hospital
Ningbo, Zhejiang
Chuangzhou Rao
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Wei Zheng
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Dingzhi Huang
Hubei Cancer Hospital
Wuhan, Hubei
the First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
Henan Provincial People's Hospital
Zhengzhou, Henan
Tianhui Gao
About this study
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
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)
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Efgbemalenograstim alfa
- Keywords
- Lung Cancer, Chemotherapy, Efgbemalenograstim alfa, Absolute Neutrophil Count (ANC) Reduction, Febrile Neutropenia
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efgbemalenograstim alfaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group（primary prevention） | Experimental | Efgbemalenograstim alfa, 20 mg, subcutaneous injection, administered 48±4 hours after the completion of each chemotherapy cycle. Receives: Drug: Efgbemalenograstim alfa |
| control group（secondary prevention） | Active comparator | 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. Receives: Drug: Efgbemalenograstim alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to a year and a half after starting chemotherapy
Secondary outcomes (3)
The incidence rate of FN
The incidence rate of febrile neutropenia (FN) for each cycle
Measured: Up to a year and a half after starting chemotherapy
The incidence rate of Grade ≥3 ANC reduction
The incidence rate of Grade ≥3 ANC reduction during chemotherapy cycles 2-4/6
Measured: Up to a year and a half after starting chemotherapy
Adverse Events
Including adverse events/serious adverse events and their incidence rates
Measured: Up to a year and a half after starting chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start31 Dec 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143735
- Sponsor's protocol ID
- GUARD-03
- Status last verified
- May 2023
- First submitted
- 16 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individal participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06143735
- Acronym / sponsor ID
- GUARD-03
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Lung Cancer, Chemotherapy, Efgbemalenograstim alfa, Absolute Neutrophil Count (ANC) Reduction, Febrile Neutropenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 31 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group（primary prevention） | Experimental | Drug: Efgbemalenograstim alfaEfgbemalenograstim alfa, 20 mg, subcutaneous injection, administered 48±4 hours after the completion of each chemotherapy cycle. |
| control group（secondary prevention） | Active comparator | Drug: Efgbemalenograstim alfaEfgbemalenograstim 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Participants voluntarily join this study, sign an informed consent form, exhibit good compliance, and cooperate with follow-up.
- At the time of signing the informed consent form, participants must be ≥ 18 years old, with no gender restrictions.
- Stage IIIB-IV NSCLC with negative driver mutations, who have not received chemotherapy or radiotherapy previously.
- 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).
- 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.
Key exclusion criteria (19 listed)
- Previously received chemotherapy or radiotherapy, including but not limited to neoadjuvant chemoradiotherapy and/or adjuvant chemoradiotherapy.
- Underwent bone marrow transplantation or stem cell transplantation.
- Concurrently diagnosed with malignancies other than NSCLC.
- 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.
- Diagnosed with acute congestive heart failure, cardiomyopathy, or myocardial infarction by clinical, electrocardiogram, or other means.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efgbemalenograstim alfaEfbemalenograstim 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. | Drug | control group（secondary prevention）, experimental group（primary prevention） |
Primary outcome
The incidence rate of Grade ≥3 ANC reduction
Time frame: Up to a year and a half after starting chemotherapy
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.
3 secondary outcomes
The incidence rate of FN
Time frame: Up to a year and a half after starting chemotherapy
The incidence rate of Grade ≥3 ANC reduction
Time frame: Up to a year and a half after starting chemotherapy
Adverse Events
Time frame: Up to a year and a half after starting chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Yes. De-identified individal participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Efgbemalenograstim alfa in people with Non Small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dingzhi Huang (+86-22-23340123-1031, dingzhih72@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of Grade ≥3 ANC reduction (time frame: Up to a year and a half after starting chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.