Guard 01: A randomized, multicentre, controlled trail on the prophylactic use of efbemalenograstim alfa for concurrent chemo-radiotherapy induced neutropenia.

Abstract

TPS12155 Background: Concurrent chemo-radiotherapy plays a crucial role in the treatment of various advanced-stage malignant tumors. However, it is often associated with significant hematologic toxicity, especially leukopenia and neutropenia, which may lead to treatment interruptions, reduced efficacy, and even severe infections. Efbemalenograstim alfa is a novel long-acting recombinant human granulocyte colony stimulating factor (rhG-CSF) combined of an immunoglobulin (Ig) G2-Fc fragment and two rhG-CSF molecules. Although efbemalenograstim alfa has been confirmed to be effective in the prevention of chemotherapy induced neutropenia by a number of clinical studies, its prophylactic efficacy during concurrent chemo-radiotherapy was seldom investigated. Guard-01 is aimed to evaluate the effectiveness and safety of primary preventive use of efbemalenograstim alfa in concurrent chemo-radiotherapy. Methods: This study is a multicenter, open-label, randomized, controlled clinical trial involving 120 patients who are planned to receive definitive concurrent chemo-radiotherapy with non-small cell lung cancer, small cell lung cancer, esophageal cancer, nasopharyngeal carcinoma, head and neck squamous cell carcinoma, or cervical cancer. Patients will be randomized into efbemalenograstim alfa arm or control arm in a 1:1 ratio on the first day of the first concurrent chemo-radiotherapy cycle. The stratification factor is chemotherapy regimen of the patients. Approximately 48 (±4) hours after the completion of each chemotherapy cycle, patients in the efbemalenograstim alfa arm will receive efbemalenograstim alfa (20 mg per dose, subcutaneous injection) for prevention. Patients in the control arm will receive rhG-CSF (5 μg/kg/day) when the absolute neutrophil count (ANC) is less than 1.0×109/L, and treatment will be discontinued when ANC reaches ≥5×109/L. The primary endpoint is the incidence of grade ≥3 neutropenia (ANC<1.0×109/L) during concurrent chemo-radiotherapy. The trial is opened in November 2023 and will be conducted in 8 hospitals with the aim of recruiting 120 evaluable patients (4 patients are recruited untilled 29-Jan-2024). Clinical trial information: ChiCTR2300077504.