Trial Title:
A Multi-cohort Study of Efbemalenograstim Alfa Injection for Preventing ANC Reduction in Solid Tumor Patients Post Immune-chemotherapy.
NCT ID:
NCT06649448
Condition:
Solid Tumor Cancer
Chemotherapy Induced Neutropenia
G-CSF
Conditions: Official terms:
Neutropenia
Paclitaxel
Etoposide
Cisplatin
Carboplatin
Pemetrexed
Conditions: Keywords:
ICI combined with chemotherapy
ANC
G-CSF
Solid Tumor
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Efbemalenograstim alfa Injection
Description:
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.
Arm group label:
Cohort 1
Arm group label:
Cohort 2
Arm group label:
Cohort 3
Intervention type:
Drug
Intervention name:
carboplatin/cisplatin-etoposide
Description:
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.
Arm group label:
Cohort 1
Intervention type:
Drug
Intervention name:
Carboplatin plus Paclitaxel
Description:
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).
Arm group label:
Cohort 2
Intervention type:
Drug
Intervention name:
Cisplatin/pemetrexed or Carboplatin/pemetrexed
Description:
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).
Arm group label:
Cohort 2
Intervention type:
Drug
Intervention name:
TP regimen
Description:
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).
Arm group label:
Cohort 3
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).
Detailed description:
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shandong Cancer Hospital and Institute
Address:
City:
Jinan
Zip:
250117
Country:
China
Contact:
Last name:
Linlin Wang
Phone:
0086+13793187739
Email:
wanglinlinatjn@163.com
Start date:
October 10, 2024
Completion date:
May 31, 2026
Lead sponsor:
Agency:
Shandong Cancer Hospital and Institute
Agency class:
Other
Source:
Shandong Cancer Hospital and Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06649448
