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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.
PRIMARY OBJECTIVE:
I. To evaluate the progression-free survival (PFS) and overall survival of chemoimmunotherapy sequential residual tumor irradiation in patients with extensive stage small cell lung cancer (SCLC).
SECONDARY OBJECTIVES:
II. To assess the overall response rate (ORR) and toxicity in extensive stage SCLC patients treated with chemoimmunotherapy squential residual tumor irradiation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined chemotherapy and immunotherapy plus residual lesion irradiation | Patients receive carboplatin 5/AUC intravenously (IV) on day 1, adebrelimab 1200mg IV on day 1, and etoposide100mg/m2 IV on days 1-3. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity; redsidual tumor irradiation for 50GY in 25 fraction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| residual tumor irradiation | Radiation | lung residual tumor will be given external beam irradiation for 50GY in 25 fractions in total |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival (PFS) | PFS: time to disease progression or patient death | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS: time to patient death | 36 months |
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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:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chunling zhang, md | Contact | 1718865657 | kevinji78@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| chunling zhang, md | Qingdao Central Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qingdao Central Hospital | Recruiting | Qingdao | Shandong | 266042 | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Qingdao Central Hospital | Recruiting | Qingdao | Shandong | 266042 | China |
|
| Qingdao Central Hospital | Recruiting | Qingdao | Shandong | 266042 | China |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |