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 range18 Years – 85 Years
SexALL
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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.
✓. Expected survival of at least 12 weeks.
✓. 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.
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
. 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.