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

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).

Conditions

• Solid Tumor Cancer
• Chemotherapy Induced Neutropenia
• G-CSF

Interventions

DRUG

Efbemalenograstim alfa Injection

This product should be administered subcutaneously 48 hours after the completion of anti-tumor drug administration in each chemotherapy cycle. The recommended dose for adults is 20mg administered subcutaneously once per chemotherapy cycle. Please do not administer this product within 14 days before and 24 hours after the administration of cytotoxic chemotherapy drugs.

DRUG

carboplatin/cisplatin-etoposide

one of the following chemotherapy regimens can be selected: EC, Q3W: Carboplatin AUC = 5\~6 on Day 1; Etoposide 80\~100 mg/m² on Days 1-3. EP, Q3W: Cisplatin 75\~80 mg/m² on Day 1; Etoposide 80\~100 mg/m² on Days 1-3.

DRUG

Carboplatin plus Paclitaxel

For non-small cell lung cancer (squamous cell carcinoma), one of the following chemotherapy regimens can be selected: Carboplatin AUC = 5\~6 on Day 1 + Taxane: Paclitaxel 175-200 mg/m² on Day 1; or Albumin-bound Paclitaxel 200-260 mg/m² on Day 1, administered every 3 weeks (Q3W); Cisplatin/Carboplatin 75 mg/m²/AUC = 5\~6 on Day 1 + Gemcitabine 1000 mg/m² on Days 1 and 8, administered every 3 weeks (Q3W).

DRUG

Cisplatin/pemetrexed or Carboplatin/pemetrexed

For non-small cell lung cancer (non-squamous cell carcinoma), one of the following chemotherapy regimens can be selected: Cisplatin 75 mg/m² on Day 1 + Pemetrexed 500 mg/m² on Day 1, administered every 3 weeks (Q3W). Carboplatin AUC = 5\~6 on Day 1 + Pemetrexed 500 mg/m² on Day 1, administered every 3 weeks (Q3W).

DRUG

TP regimen

The chemotherapy regimen options include: TP regimen: Cisplatin 60-80 mg/m² administered via intravenous drip on Day 1 + Taxane: Paclitaxel 175 mg/m² on Day 1; or Albumin-bound Paclitaxel 200-260 mg/m² on Day 1, with a treatment cycle of every 3 weeks (Q3W).

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute

  lead OTHER

Principal Investigators

• JinMing Yu, Phd · Shandong Cancer Hospital and Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-10

Primary Completion

2025-12-31

Completion

2026-05-31

Countries

• China

Study Locations