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

NANot yet recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

October 10, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

May 31, 2026

Conditions
Solid Tumor CancerChemotherapy Induced NeutropeniaG-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)."

Trial Locations (1)

250117

Shandong Cancer Hospital and Institute, Jinan

All Listed Sponsors
lead

Shandong Cancer Hospital and Institute

OTHER