Combining chemoimmunotherapy with radiation for extensive stage small-cell lung cancer

Chemoimmunotherapy Plus Ratiotherapy for Extensive Stage Small-cell Lung Cancer

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
• Enrollment: 70 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Qingdao Central Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Qingdao, Shandong and 2 other locations)
• Trial ID: NCT06514118 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of extensive stage small-cell lung cancer and measurable disease.

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.

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 performed: While the combination of chemoimmunotherapy and radiation is a novel approach in this specific context, similar strategies have shown promise in other cancer types.

Eligibility 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 this trial is running

Qingdao, Shandong and 2 other locations

• 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

Conditions Small-cell Lung Cancer; Residual Tumor; Radiation