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).
Patients voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-ups;
Aged 18 years or older, regardless of gender;
Patients with histologically or cytologically confirmed stage IV small cell lung cancer (SCLC) (as per the 8th edition of the American Joint Committee on Cancer (AJCC)) or T3-4 SCLC with multiple pulmonary nodules or tumors/nodules too large to be included in a tolerable radiotherapy plan, stage IV non-small cell lung cancer (NSCLC) (as per the 8th edition of the International Association for the Study of Lung Cancer (IASLC) Thoracic Oncology Staging Manual), or stage IV esophageal squamous cell carcinoma (excluding adenosquamous carcinoma) who are not eligible for radical therapy;
Patients who have not previously received systemic anti-tumor therapy for advanced/metastatic disease. For patients who have received neoadjuvant/adjuvant and radical concurrent chemoradiotherapy, screening is allowed if the time from the last chemotherapy to recurrence or progression exceeds 6 months. For patients who have received radiotherapy alone, screening is allowed after disease progression;
Patients diagnosed with acute congestive heart failure, cardiomyopathy, or myocardial infarction through clinical examination, electrocardiogram, or other means;
Individuals with a history of rubber allergy;
Patients who have received radiotherapy for bone lesions (patients who have received radiotherapy for lesions other than bone lesions can be enrolled 4 weeks after treatment);
Patients who have undergone bone marrow transplantation or stem cell transplantation;
Parallel
Efbemalenograstim alfa Injection
DrugThis 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.
carboplatin/cisplatin-etoposide
Drugone 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.
Carboplatin plus Paclitaxel
DrugFor 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).
Cisplatin/pemetrexed or Carboplatin/pemetrexed
DrugFor 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).
TP regimen
DrugThe 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.
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;
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;
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.
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;
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