Trial reportBMC cancer2025
Telpegfilgrastim for chemotherapy-induced neutropenia in patients with non-small cell lung cancer: a multicentre, randomized, phase 3 study.
Trial report in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04466137 (A Multi-centers, Randomized, Open-labeled, Positive-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF, Once-per-cycle, in Patients With Malignancies Receiving Myelosuppressive Chemotherapy.), which is not on this map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi-centers, Randomized, Open-labeled, Positive-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF, Once-per-cycle, in Patients With Malignancies Receiving Myelosuppressive Chemotherapy.
Who cites it
2 citing papers in PubMed.
- Comparative efficacy and safety of four long-acting granulocyte colony-stimulating factors for primary prophylaxis in patients with breast cancer: a prospective observational cohort study in China.EClinicalMedicine · 2026Article
- Pegylated recombinant human granulocyte colony-stimulating factor enhances radiotherapy completion and safety in concurrent chemoradiotherapy for cervical cancer: a retrospective analysis.Frontiers in oncology · 2025Article
Corrections and comments
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Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundChemotherapy-induced neutropenia (CIN) is usually managed by recombinant human granulocyte colony stimulating factor (rhG-CSF) and pegylated rhG-CSF (PEG-rhG-CSF). This study evaluated the efficacy and safety of telpegfilgrastim, a novel Y-shaped PEG-rhG-CSF, for CIN prophylaxis in patients with non-small cell lung cancer (NSCLC).
methodsThis was a multicentre, randomized, open-label, active-controlled non-inferiority study. Patients with NSCLC who received 1-4 chemotherapy cycles of docetaxel plus carboplatin were randomized 1:1:1 to receive telpegfilgrastim 2 mg, 33 µg/kg or control drug (rhG-CSF [Topneuter®] in cycle 1 of chemotherapy, rhG-CSF [Topneuter®] or PEG-rhG-CSF [Xinruibai®] per patients' choice in cycles 2-4 of chemotherapy). The primary endpoint was duration of grade 4 neutropenia in cycle 1 of chemotherapy. Secondary endpoints included duration of grade 4 neutropenia in cycles 2-4 of chemotherapy, incidence of febrile neutropenia (FN), duration and incidence of ≥ grade 3 neutropenia, dynamic change of absolute neutrophil count from baseline and safety.
resultsFrom October 16, 2020, to September 1, 2021, 133 patients were randomized to telpegfilgrastim 2 mg (n = 44), 33 µg/kg (n = 45) and control group (n = 44). In cycle 1 of chemotherapy, the mean duration of grade 4 neutropenia in telpegfilgrastim 2 mg, 33 µg/kg groups and control group were 0.02 day, 0.09 day and 0.16 day, respectively. The least square mean differences versus control group were -0.14 day [95% confidence interval [CI]: -0.35, 0.06] for telpegfilgrastim 2 mg group and -0.06 day [95% CI: -0.26, 0.15] for telpegfilgrastim 33 µg/kg group. which met the prespecified non-inferiority margin of 1 day. Incidence of grade 4 neutropenia, incidence of FN and duration of ≥ grade 3 neutropenia in cycles 1-4 of chemotherapy was similar between telpegfilgrastim groups and control group. Telpegfilgrastim was well tolerated, and the incidence of adverse events were comparable with control group.
conclusionThis study demonstrated that telpegfilgrastim 2 mg or 33 μg/kg was non-inferior to rhG-CSF (Topneuter®) and PEG-rhG-CSF (Xinruibai®) for the management of CIN in patients with NSCLC. In particular, a 2 mg fixed dose of telpegfilgrastim presents a more convenient administration option.
trial registrationNCT04466137 , July 10, 2020.
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