This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of adebelizumab combined with carboplatin/Cisplatin plus (+) etoposide and concurrent radiotherapy in the first-line treatment of patients with extensive stage oligometastatic small cell lung cancer.
Participants will receive Adebrelimab intravenously in combination with carboplatin /Cisplatin and etoposide during the induction phase (2 Cycles ). Thereafter, participants will receive concurrent chemoradiotherapy(thoracic radiation therapy and SBRT for metastases,combination with carboplatin /Cisplatin and etoposide for 1-2 Cycles).Then participants will receive Adebrelimab combination with carboplatin /Cisplatin and etoposide for 1-2 Cycles,followed by Adebrelimab maintenance until persistent radiographic PD, intolerable toxicity or withdrawal of consent during the maintenance phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Adebrelimab intravenous infusion will be administered during the induction phase (Cycles 1-2 ) and maintenance phase.
Carboplatin/Cisplatin intravenous infusion will be administered during the induction phase, concurrent chemoradiotherapy phase and maintenance phase(Cycles 1-4 or 6).
Etoposide intravenous infusion will be administered during the induction phase, concurrent chemoradiotherapy phase and maintenance phase(Cycles 1-4 or 6).
IMRT for thoracic of 45--55Gy in 15-22 fractions,SBRT for metastases during the concurrent chemoradiotherapy phase
Nanfang Hospital, Southern Medical University
Guangzhou, China
RECRUITINGProgression-Free Survival (PFS)
Time frame: up to approximately 30 months
Overall Survival (OS)
Time frame: up to approximately 30 months
Objective Response Rate (ORR)
Time frame: up to approximately 30 months
Disease control rate (DCR)
Time frame: up to approximately 30 months
Duration of Response (DOR)
Time frame: up to approximately 30 months
Percentage of Participants Alive at 1 Year and 2 Years
Time frame: 1 year, 2 years
Percentage of Participants Alive and Without PD at 6 Months and 1 Year
Time frame: 6 months, 1 year
Percentage of Participants with Adverse Events Or Serious Adverse Events
Time frame: up to approximately 30 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.