Chemoimmunotherapy Plus Ratiotherapy for Extensive Stage Small-cell Lung Cancer

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Radiation
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• \>= 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.

Locations
Other Locations
China
Qingdao Central Hospital
RECRUITING
Qingdao
Qingdao Central Hospital
RECRUITING
Qingdao
Qingdao Central Hospital
RECRUITING
Qingdao
Contact Information
Primary
chunling zhang, md
kevinji78@yahoo.com
1718865657
Time Frame
Start Date: 2024-04-17
Estimated Completion Date: 2027-03-16
Participants
Target number of participants: 70
Treatments
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.
Sponsors
Leads: Qingdao Central Hospital

This content was sourced from clinicaltrials.gov