A Phase 2 interventional study of Gefitinib and Anlotinib in Non-small Cell Lung Cancer and EGFR Gene Mutation, sponsored by Second Affiliated Hospital of Nanchang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-04-24.
Sponsored by Second Affiliated Hospital of Nanchang University · Phase 2, Interventional, and Treatment
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.
6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's planned enrollment of 240 is above the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Second Affiliated Hospital of Nanchang University is the lead sponsor of 78 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
If persistence of plasma ctDNA EGFRm after 8 weeks of gefitinib first-line treatment, Gefitinib 250mg oral daily and Anlotinib 10mg oral d1-14, every 3 weeks
Drug: Gefitinib · Drug: Anlotinib
If clearance of plasma ctDNA EGFRm after 8 weeks of gefitinib first-line treatment, Gefitinib 250mg oral daily
Drug: Gefitinib
If persistence of plasma ctDNA EGFRm after 8 weeks of gefitinib first-line treatment
Also known as: Iressa
If clearance of plasma ctDNA EGFRm after 8 weeks of gefitinib first-line treatment
Also known as: AL3818
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
Plan to share: No
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Second Affiliated Hospital of Nanchang University