Solid Tumor CancerEF-001NCT06649448
A Multi-cohort Study of Efbemalenograstim Alfa Injection for Preventing ANC Reduction in Solid Tumor Patients Post Immune-chemotherapy.
A study testing Efbemalenograstim alfa Injection, carboplatin/cisplatin-etoposide and Carboplatin plus Paclitaxel in people with Solid Tumor Cancer and Chemotherapy Induced Neutropenia, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Cancer, Chemotherapy Induced Neutropenia, G-CSF
- What is being tested?
- Efbemalenograstim alfa Injection, carboplatin/cisplatin-etoposide and Carboplatin plus Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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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;
- Left ventricular ejection fraction \> 50%;
- The investigator judges that the patient can tolerate the treatment with Abegrimacostat Alpha.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117
Linlin Wang, 0086+13793187739, wanglinlinatjn@163.com
About this study
Official title: A Multi-cohort, Open-label, Multi-center Exploratory Study of Efbemalenograstim Alfa Injection for Preventing Absolute Neutrophil Count (ANC) Reduction in Solid Tumor Patients Undergoing Immune-chemotherapy Regimen.
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).
Read more
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).
Read the 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.
- Conditions
- Solid Tumor Cancer, Chemotherapy Induced Neutropenia, G-CSF
- Being tested
- Efbemalenograstim alfa Injection, carboplatin/cisplatin-etoposide, Carboplatin plus Paclitaxel, Cisplatin/pemetrexed or Carboplatin/pemetrexed, TP regimen
- Keywords
- ICI combined with chemotherapy, ANC, G-CSF, Solid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efbemalenograstim alfa InjectionDrug
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.
carboplatin/cisplatin-etoposideDrug
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.
Carboplatin plus PaclitaxelDrug
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).
Cisplatin/pemetrexed or Carboplatin/pemetrexedDrug
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).
TP regimenDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Small cell lung cancer (SCLC) patients receiving ICI combined with chemotherapy (etoposide + carboplatin/cisplatin). Receives: 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). Receives: 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). Receives: Drug: Efbemalenograstim alfa Injection; Drug: TP regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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;
Measured: 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;
Measured: 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.
Measured: 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;
Measured: 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;
Measured: From the start of treatment to the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start10 Oct 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinming Yu, Shandong Cancer Hospital and Institute
- Investigators
- JinMing Yu, Phd, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649448
- Sponsor's protocol ID
- SDZLEC2024-115-02
- Acronym
- EF-001
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-cohort, Open-label, Multi-center Exploratory Study of Efbemalenograstim Alfa Injection for Preventing Absolute Neutrophil Count (ANC) Reduction in Solid Tumor Patients Undergoing Immune-chemotherapy Regimen.
- ClinicalTrials.gov ID
- NCT06649448
- Acronym / sponsor ID
- EF-001 / SDZLEC2024-115-02
- Conditions
- Solid Tumor Cancer, Chemotherapy Induced Neutropenia, G-CSF
- Keywords
- ICI combined with chemotherapy, ANC, G-CSF, Solid Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 10 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Efbemalenograstim alfa Injection, Drug: carboplatin/cisplatin-etoposideSmall cell lung cancer (SCLC) patients receiving ICI combined with chemotherapy (etoposide + carboplatin/cisplatin). |
| Cohort 2 | Experimental | Drug: Efbemalenograstim alfa Injection, Drug: Carboplatin plus Paclitaxel, Drug: Cisplatin/pemetrexed or Carboplatin/pemetrexedNon-small cell lung cancer (NSCLC) patients receiving ICI combined with chemotherapy (platinum-based/taxane, pemetrexed/platinum). |
| Cohort 3 | Experimental | Drug: Efbemalenograstim alfa Injection, Drug: TP regimenEsophageal squamous cell carcinoma (ESCC) patients receiving ICI combined with chemotherapy (TP, which stands for cisplatin + taxane). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efbemalenograstim alfa InjectionThis 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. | Drug | Cohort 1, Cohort 2, Cohort 3 |
| carboplatin/cisplatin-etoposideone 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. | Drug | Cohort 1 |
| Carboplatin plus PaclitaxelFor 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). | Drug | Cohort 2 |
| Cisplatin/pemetrexed or Carboplatin/pemetrexedFor 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). | Drug | Cohort 2 |
| TP regimenThe 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). | Drug | Cohort 3 |
Primary outcome
The incidence rate of ≥ Grade 3 neutropenia in the first chemotherapy cycle
Time frame: At the end of Cycle 1 (each cycle being 21 days)
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.
5 secondary outcomes
The incidence rate of ≥ Grade 3 neutropenia in the second and subsequent cycles
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
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
Time frame: From the start of treatment to the end of treatment
The incidence rate and duration of FN (Febrile Neutropenia) in each cycle
Time frame: From the start of treatment to the end of treatment
The duration of ≥ Grade 3 neutropenia in each cycle
Time frame: From the start of treatment to the end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JinMing Yu, Phd principal investigator
Shandong Cancer Hospital and Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efbemalenograstim alfa Injection, carboplatin/cisplatin-etoposide and Carboplatin plus Paclitaxel in people with Solid Tumor Cancer and Chemotherapy Induced Neutropenia, run by Shandong Cancer Hospital and Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JinMing Yu, PhD (86+13806406293, jn7984729@public.jn.sd.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of ≥ Grade 3 neutropenia in the first chemotherapy cycle (time frame: At the end of Cycle 1 (each cycle being 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.