TKIs therapy is the first-line treatment of patients with EGFR mutation advanced NSCLC.However, some patients have poor prognosis of drug resistance in the early stage. The dynamic alterations of ctDNA-based EGFR mutation after TKIs treatment is a predictor of the efficacy of TKIs treatment, which can be used to identify this part of patients in the early stage.Drug resistance can be overcome when TKIs is combined with drugs in different mechanisms of action, such as chemotherapy and anti-angiogenesis therapy.Gefitinib is the first-generation oral EGFR TKIs. Anlotinib is a domestic oral small molecule inhibitor of multireceptor tyrosine kinase, which has extensive inhibitory effect on tumor angiogenesis and growth.Gefitinib combined with anlotinib is a new option in the treatment of patients with uncleared plasma EGFRm after gefitinib treatment.
This is an open-label, prospective, randomized, controlled phase II clinical trial.To evaluate the efficacy and safety of gefitinib combined with anlotinib versus gefitinib alone in advanced non-squamous NSCLC patients whose EGFRm was not cleared in plasma ctDNA after 8 weeks of gefitinib first-line treatment, so as to provide clinical basis for a new and tolerable treatment that can prolong the survival time of patients with advanced NSCLC. Study therapy continued until disease progression, unacceptable adverse event, or withdrawal of consent. The efficacy and adverse reactions of the trial regimen will be evaluated according to RECIST criteria and NCI-CTC AE V3.0.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
The Second Afiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
progression-free survival, PFS
The period from the start of treatment to the progression or death of a patient
Time frame: Every 6 weeks up to 2 years
overall survival, OS
time from the beginning of study to death due to any cause or last follow-up
Time frame: Every 6 weeks up to 2 years, and then every 3 months up to 5 years
Objective Response Rate, ORR
ORR, proportion of patients with a best overall response of complete response or partial response (CR+PR)
Time frame: 6 weeks after treatment
adverse events
Number of patients with adverse events (AEs) as a measure of safety and tolerability
Time frame: Every 6 weeks up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.