A phase II study to assess the efficacy and safety of Fruquintinib Combined With Sintilimab and Chemotherapy as a first-line treatment in patients with unresectable or metastatic advanced Wild-type Genotype non-squamous Non-small Cell Lung Cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Fruquintinib,fruquintinib at the dose determined in phase safety lead-in,5mg-intermittent (2 weeks on/ 1 week off) ,po,every 3 weeks(q3w) ; Sintilimab at the dose 200mg,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=4\~5,iv,d1;given every 3 weeks (q3w); Maintenance treatment:After 4\~6 cycles of carboplatin treatment, Sintilimab 200mg, iv, d1, q3w;Fruquintinib RP2D intermittent(2 weeks on/1 weeks off), po,q3w; pemetrexed 500mg/m2, d1,iv, q3w until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal
Jiangsu Province Hospital
Nanjing, Jiangsu, China
RECRUITINGProgression Free Survival (PFS)
To assess the efficacy of Fruquintinib Combined With Chemotherapy as second-
Time frame: up to 24 months
Objective response rate (ORR)
CR + PR rate according to the RECIST version 1.1 guidelines.
Time frame: up to 24 months
Disease control rate (DCR)
CR + PR + SD rate according to the RECIST
Time frame: up to 24 months
Overall Survival(OS)
Overall survival is determined from the date of treatment to death from any cause or the last follow-up date
Time frame: up to 24 months
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