A Study of Efbemalenograstim Alfa Injection for Stage IIIB or IV NSCLC Recieving Moderate-risk Fe… (NCT06143735) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study of Efbemalenograstim Alfa Injection for Stage IIIB or IV NSCLC Recieving Moderate-risk Febrile Neutropenia (FN) Chemotherapy Regimen With Risk Factors
China99 participantsStarted 2023-12-31
Plain-language 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)
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence rate of Grade ≥3 ANC reduction
Timeframe: Up to a year and a half after starting chemotherapy
Trial details
NCT IDNCT06143735
SponsorTianjin Medical University Cancer Institute and Hospital
. Normal function of major organs, meeting the following criteria:
. 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.
Exclusion criteria
. 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.
. 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.