This study is a one arm, open, single center phase II study. The main purpose of this study was to evaluate the tolerance and preliminary efficacy of SHR1316 combined with chest radiotherapy after induction therapy.
This is a single-arm, single-center phase II study. Eligible subjects will receive the following treatment regimens: 4\~6 cycles of SHR1316 combined with EP/EC (etoposide, 100mg/m2, D1-3, q3w and cisplatin, 75mg/m², D1, q3w or carboplatin, AUC=5, D1, q3w). Patients with response sequentially received adebrelimab combined with chest radiotherapy based on investigator decision. Patients then the maintenance therapy with adebrelimab until disease progression or intolerable AEs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Anti-PD-L1 antibody
Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
overall survival (OS)
Time frame: Up to approximately 36 months
progression-free survival (PFS)
Time frame: Up to approximately 36 months
Objective Response Rate (ORR)
Time frame: Up to approximately 36 months
disease control rate (DCR)
Time frame: Up to approximately 36 months
Duration of Response (DOR)
Time frame: Up to approximately 36 months
Adverse events
Safety, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) per CTCAE 5.0 criteria
Time frame: Up to approximately 36 months
6- and 12-month PFS rates
Percentage of Participants Alive and Without PD, as Assessed by the Investigator Using RECIST v1.1, at 6 Months and 12 Months
Time frame: 6 Months and 12 Months
1- and 2-year OS rates
Percentage of Participants Alive at 1 Year and 2 Years
Time frame: 1 Year and 2 Years
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Thoracic radiation therapy ,TRT
Cisplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).