About this trial
This is a phase II trial studies the effect of chemoimmunotherapy sequential residual tumor irradiation in treating patients with extensive stage small cell lung cancer. Even though small cell lung cancer is initially highly responsive to first-line chemotherapy plus PD-L1 inhibitors, treatment resistance inevitably happens. Residual tumor irradiation my prolong drug resistance, and may help prevent the growth and spread of the tumor cells to other parts of the body.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial population
Patients with extensive disease of small-cell lung cancer are enrolled and treated with chemotherapy plus PD-L1 immunotherapy for 4 cycles. Patients with esponse or stable disease are selected to receive residual lesions irratiation for 50GY/25f.
Trial design
Cohort
Prospective
Treatments tested in this trial
residual tumor irradiation
Radiationlung residual tumor will be given external beam irradiation for 50GY in 25 fractions in total
Treatment groups
Trial outcomes
Primary outcomes
progression-free survival (PFS)
PFS: time to disease progression or patient death
Secondary outcomes
Overall survival (OS)
OS: time to patient death
Sponsors and contacts
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