Trial Title:
A Study of Adebrelimab Combined With Apatinib Mesylate and Chemotherapy for Neoadjuvant Therapy and Biomarker Analysis in Limited-stage Small Cell Lung Cancer
NCT ID:
NCT06483282
Condition:
Small Cell Lung Cancer Limited Stage
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Carboplatin
Etoposide
Apatinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
This product is administered by intravenously guttae. The recommended dose of
subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W).
Arm group label:
Adebrelimab in combination with chemotherapy and apatinib mesylate
Other name:
SHR-1316
Intervention type:
Drug
Intervention name:
Apatinib Mesylate
Description:
This product is an orally administered targeted therapy drug, with a recommended dosage
of one tablet per day.
Arm group label:
Adebrelimab in combination with chemotherapy and apatinib mesylate
Intervention type:
Drug
Intervention name:
Etoposide
Description:
This product is administered by intravenously guttae. The recommended dose of
subcutaneous injection is 100mg/m2, administered every 3 Weeks (Q3W).
Arm group label:
Adebrelimab in combination with chemotherapy and apatinib mesylate
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
This product is administered by intravenously guttae. AUC=5, administered every 3 Weeks
(Q3W).
Arm group label:
Adebrelimab in combination with chemotherapy and apatinib mesylate
Summary:
This is a single-arm, prospective, exploratory phase II clinical study. The study
enrolled newly diagnosed stage T1-2N0-1M0 or T3N0M0 resectable limited-stage small cell
lung cancer. Adebrelimab combined with chemotherapy for 4 cycles and apatinib mesylate
for 3 cycles. Surgery was performed within 4-8 weeks after the above treatment (the
operation was performed 4 weeks after apatinib was discontinued). According to the
results of MDT discussion, adebrelimab combined with apatinib mesylate combined with or
without radiotherapy was started 4 weeks after surgery.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age between 18 and 75 years old;
- Histologically or cytologically confirmed limited-stage small cell lung cancer
(T1-2N0-1M0 or T3N0M0).
- All lesions of the patient (including the primary lesion, lymph nodes/lesions
assessed as metastatic) must be jointly evaluated and confirmed as resectable by a
surgeon, a radiation oncologist, and a radiologist;
- The subject must have measurable target lesions (according to RECIST 1.1 criteria);
- ECOG performance status score of 0-1;
- No history of other malignancies;
- No previous treatment for small cell lung cancer-related surgery, radiotherapy,
chemotherapy, immunotherapy, or other anti-tumor treatments;
- The patient must have adequate cardiopulmonary function: the patient's FEV1 and DLCO
are both ≥50% of the predicted value, echocardiography shows LVEF ≥55%, and no clear
signs of heart failure, severe coronary artery stenosis, etc., are seen on various
tests, and the cardiopulmonary function is assessed by a surgeon as being able to
tolerate surgical treatment;
- The levels of important organ functions must meet the following requirements: a.
Bone marrow: Absolute neutrophil count (ANC) ≥1.5×10^9/L, platelets ≥100×10^9/L,
hemoglobin ≥9 g/dl; b. Good coagulation function: defined as international
normalized ratio (INR) or prothrombin time (PT) ≤1.5 times the upper limit of normal
(ULN); c. Liver: Total bilirubin ≤1.5 times the upper limit of normal, aspartate
aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit
of normal; d. Kidney: Serum creatinine ≤1.25 times the upper limit of normal or
creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml/min;
- Males with reproductive capacity and women of childbearing age must agree to use
effective contraception from the time of signing the main informed consent form
until 180 days after the last administration of the study drug. Women of
childbearing age include pre-menopausal women and post-menopausal women within 2
years. The pregnancy test result of women of childbearing age must be negative
within ≤7 days before the first administration of the study drug;
- Voluntarily participate in clinical research; fully understand and be informed about
this study and sign the informed consent form.
Exclusion Criteria:
- Inability to completely remove all lesions through surgery;
- Received anti-tumor treatment for SCLC (including but not limited to chemotherapy,
radiotherapy of the lesion area).
- Previously used immunocheckpoint inhibitors such as PD-1/PD-L1 inhibitors for
treatment.
- Any history of active autoimmune diseases or autoimmune diseases (such as uveitis,
enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis,
hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy),
tuberculosis); patients with childhood asthma that has completely resolved and does
not require any intervention in adulthood or vitiligo can be included, but patients
requiring medical intervention with bronchodilators are not eligible for inclusion;
- Have congenital or acquired immune system deficiencies, such as human
immunodeficiency virus (HIV) infected individuals, active hepatitis B (HBV DNA ≥ 500
IU/ml), hepatitis C (positive for hepatitis C antibodies and HCV-RNA is above the
lower limit of detection of the analytical method) or co-infection with both
hepatitis B and C;
- Existence of uncontrollable third-space effusions, such as a large amount of pleural
effusion or ascites or pericardial effusion;
- Subjects who need systemic treatment with corticosteroids (>10 mg/day prednisone or
equivalent) or other immunosuppressants within 14 days before the first
administration of the drug. Inhaled or topical corticosteroids are allowed, as well
as adrenal hormone replacement therapy with a dose >10 mg/day prednisone equivalent,
in the absence of active autoimmune diseases;
- Subjects who have been treated with anti-tumor vaccines or other immunostimulatory
anti-tumor drugs (interferons, interleukins, thymosin, immune cell therapy, etc.)
within 1 month before the first administration of the drug;
- Currently participating in other interventional clinical studies;
- Evidence of previous or current pulmonary fibrosis, interstitial pneumonia,
pneumoconiosis, radiation pneumonitis, drug-induced pneumonia, and severe lung
function impairment;
- Patients with severe heart disease, such as congestive heart failure grade III or
above (NYHA standard), or angina grade III or above (CCS standard), or a history of
myocardial infarction within 6 months before treatment initiation, or arrhythmias
requiring drug treatment;
- Major surgery, open biopsy, or significant trauma within 28 days before enrollment;
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem
cell transplantation;
- Pregnant or breastfeeding women; patients with fertility who are unwilling or unable
to take effective contraceptive measures;
- Known allergic reactions, hypersensitivity, or intolerance to the study drug;
- Hypertension that cannot be well controlled with antihypertensive drug treatment
(systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
- Abnormal coagulation function (INR > 2.0 or prothrombin time (PT) > 16s), with a
tendency to bleed or currently undergoing thrombolysis or anticoagulant treatment
(preventive use of low-dose aspirin, low molecular weight heparin is allowed);
- Significant clinical bleeding symptoms within the last 3 months or a clear tendency
to bleed, such as gastrointestinal bleeding, bleeding gastric ulcers, or patients
with vasculitis, etc., if the baseline fecal occult blood is positive, it can be
retested, and if it is still positive after retesting, an endoscopy is required
(except for those who have undergone endoscopy within 3 months and before the
baseline period to rule out such conditions);
- Arterial/venous thrombotic events within the last 6 months, such as cerebrovascular
accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral
infarction), deep vein thrombosis, and pulmonary embolism;
- Known genetic or acquired bleeding and thrombotic tendencies (such as hemophilia,
coagulation disorders, thrombocytopenia, etc.). Other conditions deemed unsuitable
for participating in the study by the researcher.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Jin, MD&Phd
Phone:
86+18806529092
Email:
jinying@zjcc.org.cn
Start date:
June 21, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Jin Ying
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06483282
