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

Launched by SHANDONG CANCER HOSPITAL AND INSTITUTE · Oct 17, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a medication called Efbemalenograstim alfa Injection, which aims to help prevent a condition known as neutropenia in patients with solid tumors who are receiving a type of chemotherapy combined with immunotherapy. Neutropenia is a reduction in white blood cells that can increase the risk of infections. The study will enroll 200 patients with specific types of lung cancer or esophageal cancer who are scheduled to undergo at least two cycles of this combined treatment. By participating, patients may contribute to understanding whether this injection can help manage the side effects of their cancer treatment.

To be eligible for this trial, participants should be at least 18 years old and have a confirmed diagnosis of advanced cancer that is not suitable for radical treatment. They must not have had prior systemic therapy for their advanced cancer and should be at risk of severe neutropenia due to their planned chemotherapy. Patients will receive the Efbemalenograstim alfa Injection during their treatment and will be monitored closely for any side effects or changes in their health. It's important to note that this study is not yet recruiting participants, so those interested should stay tuned for updates on when enrollment will begin.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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:
• 1. 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;
• 2. 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;
• • 3. Left ventricular ejection fraction \> 50%;
• • The investigator judges that the patient can tolerate the treatment with Abegrimacostat Alpha.
• Exclusion Criteria:
• • 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.