NCT06649448

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

A Multi-cohort, Open-label, Multi-center Exploratory Study of Efbemalenograstim Alfa Injection for Preventing Absolute Neutrophil Count (ANC) Reduction in Solid Tumor Patients Undergoing Immune-chemotherapy Regimen.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study is a multi-cohort, open-label, multi-center exploratory clinical trial aimed at evaluating 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. It plans to enroll 200 solid tumor patients who are scheduled to receive at least 2 cycles of ICI combined chemotherapy. 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). Eligible patients will receive Efbemalenograstim alfa Injection (20 mg/dose, subcutaneous injection) 24-72 hours after the end of each chemotherapy cycle, from the 1st to the 4th cycle of ICI combined chemotherapy. Investigators must ensure that the first cycle of chemotherapy is administered at the recommended dose according to the protocol. For the 2nd to 4th cycles, dose delays or adjustments due to toxicity are allowed, and investigators may also determine the individual chemotherapy cycles and drug doses based on the patient\'s specific condition during these cycles. After completing 4 cycles of ICI combined chemotherapy and evaluation, patients will receive subsequent treatment according to standard clinical practice. Referencing the 2023 CSCO Guidelines, the recommended ICI combined chemotherapy regimens for subjects are as follows: Cohort 1 - SCLC, referring to the \"2023 CSCO Guidelines for the Diagnosis and Treatment of SCLC\": Immune drugs (choose one): Atezolizumab 1200 mg, d1, Q3W Durvalumab 1500 mg, d1, Q3W Serplulimab 4.5 mg/kg, d1, Q3W Adebelimab 20 mg/kg, d1, Q3W Chemotherapy regimens (choose one): EC, Q3W: Carboplatin AUC=5-6, d1; Etoposide 80-100 mg/m2, d1-3 EP, Q3W: Cisplatin 75-80 mg/m2, d1; Etoposide 80-100 mg/m2, d1-3 Cohort 2 - NSCLC, referring to the \"2023 CSCO Guidelines for the Diagnosis and Treatment of NSCLC\": NSCLC (Squamous Cell Carcinoma) - Immune drugs (choose one): Pembrolizumab 200 mg, d1, Q3W Camrelizumab 200 mg, d1, Q3W Sintilimab 200 mg, d1, Q3W Tislelizumab 200 mg, d1, Q3W Serplulimab 4.5 mg/kg, d1, Q3W Atezolizumab 1200 mg, d1 + Bevacizumab 15 mg/kg, d1, Q3W Sugemalimab 1200 mg, d1, Q3W Anplitumab 200 mg, d1, Q3W NSCLC (Squamous Cell Carcinoma) - Chemotherapy regimens (choose one): Carboplatin AUC=5-6, d1 + Taxane: Paclitaxel 175-200 mg/m2, d1; or Albumin-bound Paclitaxel 200-260 mg/m2, d1, Q3W Cisplatin/Carboplatin 75 mg/m2/AUC=5-6, d1 + Gemcitabine 1000 mg/m2, d1, d8, Q3W NSCLC (Non-Squamous Cell Carcinoma) - Immune drugs (choose one): Pembrolizumab 200 mg, d1, Q3W Camrelizumab 200 mg, d1, Q3W Sintilimab 200 mg, d1, Q3W Tislelizumab 200 mg, d1, Q3W Atezolizumab 1200 mg, d1 Sugemalimab 1200 mg, d1, Q3W NSCLC (Non-Squamous Cell Carcinoma) - Chemotherapy regimens (choose one): Cisplatin 75 mg/m2, d1 + Pemetrexed 500 mg/m2, d1, Q3W Carboplatin AUC=5-6, d1 + Pemetrexed 500 mg/m2, d1, Q3W Cohort 3 - ESCC, referring to the \"2023 CSCO Guidelines for the Diagnosis and Treatment of Esophageal Cancer\": Immune drugs (choose one): Camrelizumab 200 mg, d1, Q3W Toripalimab 240 mg, d1, Q3W Sintilimab 200 mg, d1, Q3W Tislelizumab 200 mg, d1, Q3W Serplulimab 3 mg/kg intravenous infusion, d1, Q2W Chemotherapy regimen: TP regimen: Cisplatin 60-80 mg/m2 intravenous infusion, d1 + Taxane: Paclitaxel 175 mg/m2, d1; or Albumin-bound Paclitaxel 200-260 mg/m2, d1, Q3W Note: The chemotherapy schedule for cisplatin and etoposide can be modified as needed, while maintaining the total dose administered.

Conditions

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2024-10-10
• Primary completion: 2025-12-31
• Completion: 2026-05-31
• First posted: 2024-10-18
• Last updated: 2024-10-18

Locations

1 site across 1 country: China