SNPMiner Trials (Home Page)
Report for Mutation G719S
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 2 clinical trials
Clinical Trials
1 Phase II Trial of Erlotinib and BKM120 in Patients With Advanced Non Small Cell Lung Cancer Previously Sensitive to Erlotinib
Preclinical data in lung cancer cell lines showed that EGFR mutation can potentially be a positive predictor for sensitivity to BKM120. Furthermore, when the erlotinib-resistant model H1975 (LR858 and T790M mutation) was treated with BKM120, significant tumor control was observed (Novartis internal data). Therefore, combining BKM120 with erlotinib could potentially down-modulate PI3K-Akt activity resulting in a synergistic effect on cell growth inhibition and enhancing the response to erlotinib.
NCT01487265 Non Small Cell Lung Cancer Drug: BKM120 and Erlotinib MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma
These include, but are not limited to mutations in L858R (Exon 21); Exon 19 deletion; G719S, G719A, G719C mutations (Exon 19);or L861Q (laboratory report required at enrollment). --- L858R --- --- G719S ---
Primary Outcomes
Description: Percentage of patients who are alive and progression-free at 3 months (APF3) from first treatment.
Measure: Progression Free Survival at 3 Months Time: 3 monthsSecondary Outcomes
Description: Defined as the time from first treatment until death from any cause.
Measure: Overall Survival Time: every 3 months after study treatment, projected 24 monthsDescription: Defined as the time from complete or partial response (CR or PR) until objective tumor progression. Tumor measurements will be obtained using CT scans of chest, abdomen and pelvis and assessed per RECIST v 1.1. Complete response (CR) is defined as a disappearance of all lesions; partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking the baseline sum LD as reference. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for progressive disease, taking as reference the smallest (nadir) sum LD since start of treatment.
Measure: Duration of Response Time: every 8 weeks for 12 months, then every 12 weeks thereafter, estimated 18 monthsDescription: Defined as the percentage of complete and partial responses (CR + PR) among all patients. Complete response (CR) is defined as a disappearance of all lesions; partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking the baseline sum LD as reference. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for progressive disease, taking as reference the smallest (nadir) sum LD since start of treatment.
Measure: Objective Response Rate Time: every 8 weeks for 12 months, then every 12 weeks thereafter, estimated 18 monthsDescription: Adverse events will be graded using CTCAE v4.3. and will be collected until 30 days after the discontinuation of study treatment for each participant. A non-serious adverse event is any untoward medical occurrence. A serious adverse event (SAE) is an event that meets one or more of the following: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; requires intervention to prevent permanent impairment or damage. Specific AE and SAE terms are provided in the Adverse event module.
Measure: Number of Participants With Serious and Non-serious Adverse Events as a Measure of Safety. Time: Every 2 weeks for 8 weeks, then every 8 weeks thereafter, estimated 24 months2 A Randomized Open-label Phase 3 Trial Comparing Bevacizumab + Erlotinib vs Erlotinib Alone as First Line Treatment of Patients With EGFR Mutated Advanced Non Squamous Non Small Cell Lung Cancer
The purpose of this study is to test whether the combination of bevacizumab and erlotinib can prolong progression free survival as compared with erlotinib alone as first-line treatment in patients with non small cell lung cancer (NSCLC) with activating mutation of EGFR.
NCT02633189 Non-squamous Non-small Cell Lung Cancer Drug: Erlotinib Drug: Bevacizumab MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma
Inclusion Criteria: 1. Age ≥18 years 2. Histological documentation of primary non squamous lung carcinoma 3. Stage IV or IIIB disease with supraclavicular metastatic nodes (according to TNM 7th edition) 4. Activating epidermal growth factor receptor mutation (exon19 deletion or exon 21 L858R mutation or other activating/sensitizing mutations, such as exon 21 L861Q, exon 18 G719S, G719A and G719C, exon 20 S768I and V769L). --- L858R --- --- L861Q --- --- G719S ---
Primary Outcomes
Description: as determined by investigator
Measure: progression free survival Time: up to 2 yearsDescription: as determined by an independent central review board blinded to study treatment
Measure: progression free survival Time: up to 2 yearsSecondary Outcomes
Measure: overall survival Time: 1 yearMeasure: changes in quality of life scores from baseline Time: up to 2 years
Measure: number of patients with complete and partial responses , investigator assessed Time: 6 months
Measure: number of patients with complete and partial responses , centrally reviewed Time: 6 months
Measure: worst grade toxicity per patient Time: up to one year
Measure: progression free survival according to type of EGFR mutation (exon 19del, exon 21L858R, other) Time: 2 years
Other Outcomes
Description: samples taken at baseline, 6 weeks, 6 months, and at progression
Measure: number and type of EGFR mutations in plasma samples Time: up to 2 years