SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT04358562

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized Phase II Trial of Gefitinib With Anlotinib in Advanced Non-squamous NSCLC Patients With Uncleared Plasma ctDNA EGFRm After First-line Treatment With Gefitinib

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.

NCT04358562 Non-small Cell Lung Cancer EGFR Gene Mutation
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

2 Interventions

Name: Gefitinib

Description: If persistence of plasma ctDNA EGFRm after 8 weeks of gefitinib first-line treatment
Type: Drug
Group Labels: 2

Gefitinib Gefitinib with Anlotinib

Name: Anlotinib

Description: If clearance of plasma ctDNA EGFRm after 8 weeks of gefitinib first-line treatment
Type: Drug
Group Labels: 1

Gefitinib with Anlotinib


Primary Outcomes

Description: The period from the start of treatment to the progression or death of a patient

Measure: progression-free survival, PFS

Time: Every 6 weeks up to 2 years

Secondary Outcomes

Description: time from the beginning of study to death due to any cause or last follow-up

Measure: overall survival, OS

Time: Every 6 weeks up to 2 years, and then every 3 months up to 5 years

Description: ORR, proportion of patients with a best overall response of complete response or partial response (CR+PR)

Measure: Objective Response Rate, ORR

Time: 6 weeks after treatment

Description: Number of patients with adverse events (AEs) as a measure of safety and tolerability

Measure: adverse events

Time: Every 6 weeks up to 2 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

Inclusion Criteria: - Histologically confirmed that EGFR sensitive mutation (ex19del or L858R mutation) in tumor tissue was detected by non-squamous NSCLC, and EGFR mutation (ex19del or L858R mutation) in ctDNA before treatment; - Staging is IVB stage (AJCC 8th Edition) ; - According to the comprehensive judgment of many disciplines, it is impossible to be treated by operation; - PS score 0-1; - The patient has at least one measurable tumor injury (the tumor is considered unmeasurable at the site of previous radiotherapy); - Systemic anti-tumor therapy such as chemotherapy, immunotherapy and targeted therapy were not performed before entering the group; - There is no history of malignant tumor and no serious medical disease; - FEV1 ≥ 1.2L/ seconds or ≥ 50% predicted value; - Laboratory examination: White blood cell count ≥ 4 *10^9/L, neutrophil count ≥ 2.0 *10^9, platelet count ≥ 100 *10^9, hemoglobin ≥ 10 g / L, liver and kidney function and ECG were normal; - The pregnancy test was negative within 3 days before entering the group, and agreed to use medically effective contraceptive measures during the trial; - Life expectancy is more than 12 weeks; - Sign informed consent form; cooperate with regular follow-up. --- L858R ---

Inclusion Criteria: - Histologically confirmed that EGFR sensitive mutation (ex19del or L858R mutation) in tumor tissue was detected by non-squamous NSCLC, and EGFR mutation (ex19del or L858R mutation) in ctDNA before treatment; - Staging is IVB stage (AJCC 8th Edition) ; - According to the comprehensive judgment of many disciplines, it is impossible to be treated by operation; - PS score 0-1; - The patient has at least one measurable tumor injury (the tumor is considered unmeasurable at the site of previous radiotherapy); - Systemic anti-tumor therapy such as chemotherapy, immunotherapy and targeted therapy were not performed before entering the group; - There is no history of malignant tumor and no serious medical disease; - FEV1 ≥ 1.2L/ seconds or ≥ 50% predicted value; - Laboratory examination: White blood cell count ≥ 4 *10^9/L, neutrophil count ≥ 2.0 *10^9, platelet count ≥ 100 *10^9, hemoglobin ≥ 10 g / L, liver and kidney function and ECG were normal; - The pregnancy test was negative within 3 days before entering the group, and agreed to use medically effective contraceptive measures during the trial; - Life expectancy is more than 12 weeks; - Sign informed consent form; cooperate with regular follow-up. --- L858R --- --- L858R ---



HPO Nodes


HPO: