Combining chemoimmunotherapy with radiation for extensive stage small-cell lung cancer
Official title: Chemoimmunotherapy Plus Ratiotherapy for Extensive Stage Small-cell Lung Cancer
Run by Qingdao Central Hospital · NCT06514118 · Data updated 2026-11-12
This study is testing if combining a new type of cancer treatment with radiation can help people with advanced small-cell lung cancer live longer and feel better.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Qingdao Central Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Qingdao, Shandong and 2 other locations) |
| Status | Recruiting |
| Started | April 17, 2024 |
| Main results expected | March 16, 2026 |
| Study ends | March 16, 2027 |
| Registry record updated | July 23, 2024 |
| Trial ID | NCT06514118 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with a confirmed diagnosis of extensive stage small-cell lung cancer and measurable disease.
✕Probably not a fit
Patients with early-stage small-cell lung cancer or those who do not meet the eligibility criteria 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 observational study evaluates the effects of combining chemoimmunotherapy with sequential residual tumor irradiation in patients with extensive stage small-cell lung cancer (SCLC). The primary objective is to assess progression-free survival and overall survival rates, while secondary objectives include evaluating the overall response rate and treatment toxicity. The approach aims to address treatment resistance that often occurs after initial chemotherapy by targeting residual tumors with radiation therapy.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and delay disease progression in patients with extensive stage small-cell lung cancer.
How similar studies have gone: While the combination of chemoimmunotherapy and radiation is a novel approach in this specific context, similar strategies have shown promise in other cancer types.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \>= 18 years of age Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1 at the time of study treatment initiation Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC) Patient should have extensive stage disease, defined as, malignant pleural effusion, pulmonary metastases in the contralateral lung, and/or the presence of extra-thoracic metastatic disease Must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 prior to starting platinum-based systemic chemotherapy Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L Platelets \>= 100 x 10\^9/L Hemoglobin \>= 9 g/dL Serum creatinine =\< 1.5 x institution upper limit of normal (ULN) and calculated creatinine clearance of at least 15 ml/min. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x upper limit of normal (ULN) (ALT and AST =\< 5 x ULN is acceptable if liver metastases are present) Total serum bilirubin =\< 1.5 x ULN. For patients with well documented Gilbert's syndrome, total bilirubin =\< 3 x ULN with direct bilirubin within normal range. Participant must understand the investigational nature of this study and sign an approved written informed consent form prior to receiving any study related procedure. Exclusion Criteria: * ad major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered major surgery) resulting from a prior surgery Positive for immunosuppressive disease, acquired immunodeficiency syndrome (AIDS) or other immune depressing diseases. For human immunodeficiency virus (HIV), HVC and HBC-mandatory testing is required prior to enrollment Patient has known hypersensitivity to the components of the study drugs or any analogs History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, including, but not limited to: Myocardial infarction or arterial or venous thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) class III or IV disease. History of documented congestive heart failure (New York Heart Association functional classification III or IV) within 6 months prior to baseline. Poorly controlled arrhythmias
Where it's running
-
Qingdao Central Hospital
Qingdao, Shandong, China Recruiting -
Qingdao Central Hospital
Qingdao, Shandong, China Recruiting -
Qingdao Central Hospital
Qingdao, Shandong, China Recruiting
Study contacts
- Study coordinator: chunling zhang, md
- Email: kevinji78@yahoo.com
- Phone: 1718865657
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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.