A phase II study to assess the efficacy and safety of Surufatinib Combined With Toripalimab and Chemotherapy as a first-line treatment in patients with advanced non-squamous non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
Surufatinib at the dose determined in phase safety lead-in,250 mg,qd,po,every 3 weeks(q3w) ; Toripalimab at the dose 240mg,iv, d1, given every 3 weeks (q3w); Pemetrexed at the dose 500 mg/m2,iv,d1,given every 3 weeks (q3w); Carboplatin at the dose AUC=5\~6,iv,d1,given every 3 weeks (q3w) or Cisplatin at the dose 75 mg/m2,iv ,d1,q3w; Maintenance treatment:After the end of the first-line treatment, patients with CR, PR, and SD can continue to maintenance treatment with Surufatinib RP2D,d1-21,q3w+Toripalimab 240mg,d1,q3w+Pemetrexed 500mg/m2,d1,q3w was taken until the disease progressed.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGProgression Free Survival (PFS)
Time frame: up to 24 months
Objective response rate(ORR)
Time frame: up to 24 months
Disease control rate(DCR)
Time frame: up to 24 months
Overall Survival(OS)
Time frame: up to 24 months
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