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New treatment option for Small Cell Lung Cancer Limited Stage
Official title A Study of Adebrelimab Combined With Apatinib Mesylate and Chemotherapy for Neoadjuvant Therapy and Biomarker Analysis in Limited-stage Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06483282
What this study is testing
What is Adebrelimab?
Adebrelimab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for small cell lung cancer limited stage.
Also referred to as SHR-1316.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-arm, prospective, exploratory phase II clinical study. The study enrolled newly diagnosed stage T1-3N0-1M0 resectable limited-stage small cell lung cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age between 18 and 75 years old;
- Histologically or cytologically confirmed limited-stage small cell lung cancer (T1-3N0-1M0).
- All lesions of the patient (including the primary lesion, lymph nodes/lesions assessed as metastatic) must be jointly evaluated and confirmed as...
- The subject must have measurable target lesions (according to RECIST 1.1 criteria);
- ECOG performance status score of 0-1;
You likely can't join if
- 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...
- Have congenital or acquired immune system deficiencies, such as human immunodeficiency virus (HIV) infected individuals, active hepatitis B (HBV DNA...
- Existence of uncontrollable third-space effusions, such as a large amount of pleural effusion or ascites or pericardial effusion;
See the full eligibility criteria
- Age between 18 and 75 years old;
- Histologically or cytologically confirmed limited-stage small cell lung cancer (T1-3N0-1M0).
- 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...
- 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...
- 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...
- Voluntarily participate in clinical research; fully understand and be informed about this study and sign the informed consent form.
- 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...
- 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...
- Existence of uncontrollable third-space effusions, such as a large amount of pleural effusion or ascites or pericardial effusion;
- people 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...
- people 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...
- Currently participating in other treatment 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.