An interventional study of Efbemalenograstim alfa Injection and carboplatin/cisplatin-etoposide in Solid Tumor Cancer, Chemotherapy Induced Neutropenia and G-CSF, sponsored by Shandong Cancer Hospital and Institute. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-18.
Sponsored by Shandong Cancer Hospital and Institute · Not applicable, Interventional, and Prevention
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).
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.
396 studies on the registry are indexed under Neutropenia; 57 are open to participants now.
This study's planned enrollment of 200 is above the median of 93 across 276 interventional studies indexed under Neutropenia.
Browse Neutropenia studies →Shandong Cancer Hospital and Institute is the lead sponsor of 103 studies on the registry; 36 are open to participants now.
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Adequate organ and bone marrow function:
Blood routine examination criteria (without blood transfusion or blood products and without using G-CSF or other hematopoietic stimulating factors within 14 days to correct):
Hemoglobin (HB) ≥ 80g/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L; Platelet count (PLT) ≥ 100×109/L;
Biochemical examination criteria:
Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5´ ULN; if there is liver metastasis, then ALT and AST ≤ 5´ ULN; Serum creatinine ≤ 1.5´ ULN;
Exclusion Criteria:
Small cell lung cancer (SCLC) patients receiving ICI combined with chemotherapy (etoposide + carboplatin/cisplatin).
Drug: Efbemalenograstim alfa Injection · Drug: carboplatin/cisplatin-etoposide
Non-small cell lung cancer (NSCLC) patients receiving ICI combined with chemotherapy (platinum-based/taxane, pemetrexed/platinum).
Drug: Efbemalenograstim alfa Injection · Drug: Carboplatin plus Paclitaxel · Drug: Cisplatin/pemetrexed or Carboplatin/pemetrexed
Esophageal squamous cell carcinoma (ESCC) patients receiving ICI combined with chemotherapy (TP, which stands for cisplatin + taxane).
Drug: Efbemalenograstim alfa Injection · Drug: TP regimen
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.
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.
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).
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).
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).
The incidence rate of ≥ Grade 3 neutropenia in the first chemotherapy cycle
The incidence rate of ≥ Grade 3 neutropenia in the first chemotherapy cycle, defined as the percentage of individuals with ANC \< 1.0×109/L in the first chemotherapy cycle among the analyzed population.
Time frame: At the end of Cycle 1 (each cycle being 21 days)
The incidence rate of ≥ Grade 3 neutropenia in the second and subsequent cycles
The incidence rate of ≥ Grade 3 neutropenia in the second and subsequent cycles, defined as the percentage of individuals with ANC \< 1.0×109/L in chemotherapy cycles 2-4 among the analyzed population;
Time frame: At the end of the second and subsequent chemotherapy cycles(each cycle being 21 days)
The nadir (lowest value) of neutrophils in the first cycle
The nadir (lowest value) of neutrophils in the first cycle, defined as the lowest count (trough value) of neutrophils in the first cycle;
Time frame: At the end of Cycle 1 (each cycle being 21 days)
The time required for the nadir of neutrophils to recover above 2×109/L in each cycle
The time required for the nadir of neutrophils to recover above 2×109/L in each cycle, defined as the time (in days) required for the ANC nadir to recover above 2×109/L in each cycle.
Time frame: From the start of treatment to the end of treatment
The incidence rate and duration of FN (Febrile Neutropenia) in each cycle
The incidence rate and duration of FN (Febrile Neutropenia) in each cycle, defined as the percentage of individuals experiencing FN \[oral temperature \&gt; 38.3°C or oral temperature \&gt; 38.0°C measured twice consecutively within 2 hours, with ANC \&lt; 0.5×109/L or predicted to be \&lt; 0.5×109/L\] \[23\] among the analyzed population, and the duration (in days) of FN episodes;
Time frame: From the start of treatment to the end of treatment
The duration of ≥ Grade 3 neutropenia in each cycle
The duration of ≥ Grade 3 neutropenia in each cycle, defined as the duration (in days) of ANC \< 1.0×109/L in each cycle;
Time frame: From the start of treatment to the end of treatment
Plan to share: Undecided
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Shandong Cancer Hospital and Institute