This is an open-label, multi-center Phase II study designed to evaluate the efficacy and safety of Surufatinib plus anti-PD-1/L1 as maintenance therapy after first-line standard of care in patients with ES-SCLC.
This study consists of two parts, i.e., a single-arm Phase IIa study and a randomized, controlled Phase IIb study. All the enrolled patients will be patients with ES-SCLC who did not have PD (determined as per the RECIST v1.1) after prior platinum-based chemotherapy in combination with an anti-PD-1/L1. Approximately 20 patients are planned to be enrolled in the single-arm Phase IIa study to preliminarily observe the efficacy and safety. Approximately 40 patients are planned to be enrolled in the randomized and controlled Phase IIb study with 20 patients per group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
The recommended dosage is 250 mg orally once daily (QD) within 1 hour after breakfast for continuous administration.
Anti-PD-1/L1 therapy, Q3W or Q4W, the same immune checkpoint inhibitor from patients' first-line therapy.
Chinese PLA General Hospital
Beijing, China
Progression-free survival
Progression-free survival(PFS) assessed by the investigator as per the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
Time frame: About 18 months
Overall survival
Overall survival (OS)
Time frame: About 18 months
Objective response rate
Objective response rate (ORR) assessed per RECIST v1.1
Time frame: About 18 months
Disease control rate
Disease control rate (DCR) assessed per RECIST v1.1
Time frame: About 18 months
Duration of response
Duration of response (DoR) assessed per RECIST v1.1
Time frame: About 18 months
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