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

NCT06649448 | Not Yet Recruiting DMC

• 1 other identifier: SDZLEC2024-115-02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ICI combined with chemotherapy; ANC; G-CSF; Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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.

  At the end of Cycle 1 (each cycle being 21 days)

Secondary Outcomes (5)

• The incidence rate of ≥ Grade 3 neutropenia in the second and subsequent cycles

  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

  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

  From the start of treatment to the end of treatment

• The incidence rate and duration of FN (Febrile Neutropenia) in each cycle

  From the start of treatment to the end of treatment

• The duration of ≥ Grade 3 neutropenia in each cycle

  From the start of treatment to the end of treatment

Study Arms (3)

Cohort 1

EXPERIMENTAL

Small cell lung cancer (SCLC) patients receiving ICI combined with chemotherapy (etoposide + carboplatin/cisplatin).

Drug: Efbemalenograstim alfa Injection; Drug: carboplatin/cisplatin-etoposide

Cohort 2

EXPERIMENTAL

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

Cohort 3

EXPERIMENTAL

Esophageal squamous cell carcinoma (ESCC) patients receiving ICI combined with chemotherapy (TP, which stands for cisplatin + taxane).

Drug: Efbemalenograstim alfa Injection; Drug: TP regimen

Interventions

Efbemalenograstim alfa Injection DRUG

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.

Cohort 1; Cohort 2; Cohort 3

carboplatin/cisplatin-etoposide DRUG

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.

Cohort 1

Carboplatin plus Paclitaxel DRUG

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).

Cohort 2

Cisplatin/pemetrexed or Carboplatin/pemetrexed DRUG

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).

Cohort 2

TP regimen DRUG

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).

Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 planned to receive immunotherapy combined with at least 2 cycles of chemotherapy regimens with a high risk of severe neutropenia complicated by febrile neutropenia (FN) or medium FN risk regimens combined with ≥ 1 patient-specific risk factor. According to the \"Chinese Expert Consensus on Diagnosis and Treatment of Neutropenia Induced by Chemotherapy for Cancer (2023 Version)\", patient-specific factors are also crucial in influencing the risk of FN. The patient factors that increase the risk of FN mainly include: (1) Age \> 65 years and receiving full-dose chemotherapy; (2) Prior chemotherapy or radiotherapy; (3) Persistent neutropenia (\>10 days); (4) Bone marrow invasion by tumor; (5) Recent surgery and/or open trauma; (6) Poor overall physical condition with comorbidities such as liver (serum bilirubin \> 2 times the upper limit of normal (ULN)), kidney (creatinine clearance ≤ 50 ml/min), heart, lung, endocrine, and other underlying diseases; (7) Poor nutritional status; (8) Chronic immunosuppression, such as human immunodeficiency virus infection, organ transplantation, and long-term immunosuppression after transplantation; (9) Advanced disease.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0-1;
• 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;
• Left ventricular ejection fraction \> 50%;
• The investigator judges that the patient can tolerate the treatment with Abegrimacostat Alpha.

You may not qualify if:

• 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;
• Pregnant or lactating women;
• Patients with alcoholism or drug abuse that affects their compliance in participating in the study;
• Known allergy to granulocyte colony-stimulating factors or excipients in the study drug;
• Use of other investigational drugs within 1 month prior to enrollment in this study;
• Received treatment with recombinant human granulocyte colony-stimulating factor within 6 weeks prior to enrollment;
• Presence of other primary malignancies, with the following exceptions: 1) Malignancies in complete remission for at least 2 years prior to enrollment and requiring no additional treatment during the study; 2) Non-melanoma skin cancer or malignant lentigo maligna that has been adequately treated and shows no evidence of disease recurrence; 3) Carcinoma in situ that has been adequately treated and shows no evidence of disease recurrence;
• The investigator believes that the patient has a disease or symptom that makes them unsuitable for participation in this study, or that the study drug may harm the patient\'s health or affect the assessment of adverse events.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, 250117, China

Location

MeSH Terms

Interventions

Carboplatin; PE regimen; Paclitaxel; Cisplatin; Pemetrexed; TP protocol

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• JinMing Yu, Phd

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JinMing Yu, PhD

CONTACT

86+13806406293; jn7984729@public.jn.sd.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator Official Title President of Shandong Cancer Hospital and Institute

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 18, 2024
• Study Start: October 10, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

CN (1)