Telpegfilgrastim for chemotherapy-induced neutropenia in patients with non-small cell lung cancer: a multicentre, randomized, phase 3 study.

ABSTRACT:

Background

Chemotherapy-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).

Methods

This 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

SUBMITTER: Shi Y 

PROVIDER: S-EPMC11916207 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature