A phase II study to assess the efficacy and safety of Surufatinib or Surufatinib combined with Vinorelbine as third-line and posterior line treatment in patients with NSCLC
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Surufatinib,300mg, qd, po, 21 days for a cycle; continuous administration until PD, death or intolerable toxicity.
Surufatinib, 250mg, qd, po; Plus Vinorelbine, 20 mg, every 2 days; 21days for a cycle; continuous administration until PD, death or intolerable toxicity.
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGProgression-free survival (PFS)
To assess the efficacy of Surufatinib or Surufatinib Combined With Vinorelbine for NSCLC , patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time frame: up to 12 months
Objective response rate (ORR)
CR + PR rate according to the RECIST version 1.1 guidelines.
Time frame: up to 12 months
Disease control rate (DCR)
CR + PR + SD rate according to the RECIST version 1.1 guidelines.
Time frame: up to 12 months
Overall survival (OS)
The time interval between the start date of study drug and the date of death (any cause)
Time frame: up to 36 months
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