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Adebrelimab and Concurrent Radiochemotherapy as First-line Treatment for Extensive-stage Small-cell Lung Cancer
Sponsor: Henan Cancer Hospital
Summary
Patients with extensive-stage small-cell lung cancer (ES-SCLC) have poor prognosis, with limited treatment options. Chemo-immunotherapy is the standard 1st-line therapy for patients with ES-SCLC.When 4 cycles of etoposide+carboplatin (EC) or etoposide+cisplatin(EP) chemotherapy combined with PD-L1 inhibitor are effective, guidelines recommend additional thoracic radiotherapy. In this study, the investigators bring radiotherapy forward, which means that after 2 cycles of EC chemotherapy plus Adebrelimab, participants with response(PR/CR/SD)will receive concurrent radiotherapy and 2 cycles of EC chemotherapy plus Adebrelimab, then maintenance therapy with Adebrelimab (Q3W). The purpose of this study is to explore the safety and efficacy of Adebrelimab combined with concurrent chemoradiotherapy in untreated participants with extensive-stage small cell lung cancer.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2024-02-10
Completion Date
2027-12-31
Last Updated
2024-02-01
Healthy Volunteers
No
Conditions
Interventions
Adebrelimab
Etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab( PD-L1 inhibitor)1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.
Radiation Therapy
Etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab( PD-L1 inhibitor)1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.
etoposide, carboplatin(EC)
Etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab( PD-L1 inhibitor)1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.
Locations (2)
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, China