A Multi-cohort Study of Efbemalenograstim Alfa Injection for Preventing ANC Reduction in Solid Tumor Patients Post Immune-chemotherapy.

• Status: NOT_YET_RECRUITING
• Trial end date: 2026-05-31

Summary

This study is a multi-cohort, open-label, multi-center exploratory clinical research designed to evaluate the efficacy and safety of Efbemalenograstim alfa Injection in preventing neutropenia (reduction in absolute neutrophil count, ANC) in solid tumor patients undergoing immune checkpoint inhibitor (ICI) combined chemotherapy. A total of 200 solid tumor patients who are scheduled to receive at least 2 cycles of ICI combined chemotherapy will be enrolled. The study is divided into three cohorts:

Cohort 1: Small cell lung cancer (SCLC) patients receiving ICI combined with chemotherapy (etoposide + carboplatin/cisplatin).

Cohort 2: Non-small cell lung cancer (NSCLC) patients receiving ICI combined with chemotherapy (platinum-based/taxane, pemetrexed/platinum).

Cohort 3: Esophageal squamous cell carcinoma (ESCC) patients receiving ICI combined with chemotherapy (TP, which stands for cisplatin + taxane).

• Phase: NA

Details

• Lead Sponsor: Shandong Cancer Hospital and Institute
• Treatments: Carboplatin; Cisplatin; Paclitaxel; PE regimen; Pemetrexed; TP protocol