Combining adebrelimab with chemotherapy and SBRT for treating early-stage small cell lung cancer
Official title: A Single-arm, Prospective, Exploratory Study of Adebrelimab Combined With Chemotherapy and Concurrent SBRT for Neoadjuvant Treatment of Limited-stage Small Cell Lung Cancer and Analysis of Biological Markers(ASSESS)
Run by Zhejiang Cancer Hospital · NCT06562920 · Data updated 2026-11-12
This study is testing if adding the immunotherapy drug adebrelimab to chemotherapy and radiation can help people with early-stage small cell lung cancer before they have surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, prednisone, adebrelimab, adebelimumab |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | July 24, 2024 |
| Main results expected | July 31, 2027 |
| Study ends | July 31, 2028 |
| Registry record updated | August 20, 2024 |
| Trial ID | NCT06562920 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-75 with histologically confirmed limited-stage small cell lung cancer who have not received prior treatment.
✕Probably not a fit
Patients with a history of other malignancies or those who have previously undergone any anti-tumor treatments for small cell lung cancer may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness and safety of adebrelimab, an immunotherapy drug, in combination with chemotherapy and concurrent stereotactic body radiation therapy (SBRT) as a neoadjuvant treatment for patients with limited-stage small cell lung cancer (SCLC). A total of 20 patients with resectable T1-3N0-1M0 SCLC who have not received prior treatment will be enrolled. Participants will undergo three cycles of treatment followed by surgery within 4-6 weeks. The main outcomes will focus on the pathological complete response rate and safety indicators.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for patients with limited-stage small cell lung cancer.
How similar studies have gone: While there have been studies on immunotherapy for lung cancer, this specific combination approach is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-75 years old; Histologically or cytologically confirmed as limited-stage small cell lung cancer (T1-3N0-1M0); All lesions of the patient (including primary lesions, lymph nodes/metastatic lesions assessed as metastases) must be jointly evaluated by surgeons, radiotherapists, and radiologists to be surgically resectable; Subjects must have measurable target lesions (according to RECIST 1.1 standards); ECOG performance status score 0-1; No history of other malignant tumors; No previous anti-tumor treatment such as surgery, radiotherapy, chemotherapy, immunotherapy, etc. related to small cell lung cancer; Patients must have sufficient cardiopulmonary function: FEV1 and DLCO of patients are ≥50% of the predicted value, echocardiography indicates LVEF ≥55%, and no clear signs of heart failure, severe coronary artery stenosis, etc. are found in various tests. Cardiopulmonary function is assessed by surgeons to be able to tolerate surgical treatment; The functional level of each important organ must meet the following requirements: 1. Bone marrow: absolute neutrophil count (ANC) ≥1.5× 109/L, platelets ≥100 × 109/L, hemoglobin ≥9 g/dl; 2. Good coagulation function: defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; 3. 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; 4. Kidney: serum creatinine ≤1.25 times the upper limit of normal or creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml/min; Men of childbearing potential and women of childbearing age must agree to take effective contraceptive measures from the signing of the main informed consent until 180 days after the last dose of the study drug. Women of childbearing age include premenopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test result within ≤ 7 days before the first administration of the study drug; Voluntarily participate in the clinical study; fully understand and be informed of this study and sign the ICF (Informed Consent Form). Exclusion Criteria: * All lesions cannot be completely removed by surgery. Received anti-tumor treatment for SCLC (including but not limited to chemotherapy, radiotherapy of the lesion site); Previously used immune checkpoint inhibitors such as PD-1/PD-L1 inhibitors; Any active autoimmune disease or history of autoimmune disease (such as uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy), tuberculosis); Patients with complete remission of childhood asthma and no need for any intervention as an adult or vitiligo can be included, but patients who require bronchodilators for medical intervention are not included; Suffering from congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method) or co-infection with hepatitis B and hepatitis C; Presence of difficult-to-control third-cavity effusion, such as large pleural effusion or ascites or pericardial effusion; Presence of huge mediastinal masses, multiple lesions, extracapsular invasion or fusion of complex small cell lung cancer; Subjects who need systemic treatment with corticosteroids (\>10 mg/day of prednisone or equivalent) or other immunosuppressants within 14 days before the first medication. In the absence of active autoimmune diseases, inhaled or topical corticosteroids and adrenal hormone replacement therapy with a dose of \>10 mg/day of prednisone at an effective dose are allowed; Subjects who have been treated with anti-tumor vaccines or other anti-tumor drugs with immunostimulatory effects (interferon, interleukin, thymosin, immune cell therapy, etc.) within 1 month before the first medication; Subjects who are participating in other clinical studies or whose first medication time is less than 4 weeks (or 5 half-lives of the study drug) from the end of the previous clinical study (last dose); Evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia, and severe lung function impairment, etc.; Combined with severe heart disease Patients with congestive heart failure of grade III or above (NYHA standard), or angina of grade III or above (CCS standard), or a history of myocardial infarction within 6 months before the start of treatment, or arrhythmia requiring drug treatment; Major surgery, open biopsy or significant trauma within 28 days before enrollment; A known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Pregnant or lactating women; patients of childbearing potential who are unwilling or unable to take effective contraceptive measures; Known to have allergic reactions, hypersensitivity reactions or intolerance to study drugs Other conditions that the investigator believes are not suitable for participation in the study.
Where it's running
-
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: jinshi liu
- Email: liujs@zjcc.org.cn
- Phone: 057188122233
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Propranolol with Adebrelimab and Platinum Chemotherapy in Small Cell Lung Cancer
This early-phase trial tests whether adding propranolol to adebrelimab plus platinum chemotherapy is safe and may help treat small cell lung cancer in adults.
-
HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC
This study tests whether adding adebrelimab to HS-20093 helps patients with advanced non-squamous NSCLC who have already had treatment.
-
Shrinkage-free combo in LS-SCLC: SHR-7787 plus SHR-1316
This trial tests whether the combo of SHR-7787 and SHR-1316 can help adults with unresectable limited-stage small cell lung cancer after prior platinum-based chemo and radiation.
-
Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC
This study tests a combination of adebrelimab, famitinib, and chemotherapy before surgery in people with resectable locally advanced esophageal squamous cell carcinoma to see if it can lead to a complete tumor disappearance at the time of surgery.
-
A combination therapy for advanced second-line gastric cancer using apatinib with albumin-bound paclitaxel, with or without adebrelimab
This study tests whether adding adebrelimab to a regimen of apatinib and albumin-bound paclitaxel helps patients with advanced gastric or gastroesophageal junction cancer who did not respond to first-line therapy.
-
Short-course radiotherapy with Adebrelimab and platinum chemo before surgery for locally advanced cervical cancer
This trial tests a short course of radiotherapy combined with Adebrelimab and platinum chemotherapy to shrink locally advanced cervical cancer before surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.