SNPMiner Trials (Home Page)
Report for Mutation V769L
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 2 clinical trials
Clinical Trials
1 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 --- --- G719A --- --- G719C --- --- S768I --- --- V769L ---
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 years2 Phase II Trial to Evaluate Trametinib in Patients With Advanced NF1-mutant Non-small Cell Lung Cancer
Phase II trial to evaluate trametinib in patients with locally advanced non-squamous, non-small cell lung cancer (NSCLC) whose tumors harbor a non-synonymous NF-1 mutation, with progressive disease on at least one prior line of therapy.
NCT03232892 Non-small Cell Lung Cancer Drug: Trametinib MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma
bevacizumab, ipilumimab) 4. Patients with a known activating mutation in epidermal growth factor receptor (EGFR) (Exon 19 deletion, G719A, S768I, V769L, T790M, L833F, L858R, L861Q), must have progressed or been intolerant to treatment with a first-line EGFR tyrosine kinase inhibitor (TKI) (erlotinib, afatinib, or gefitinib). --- G719A --- --- S768I --- --- V769L ---
Primary Outcomes
Description: For participants receiving at least one dose of study treatment, the ORR is defined as the best overall response recorded from the start of the treatment until disease progression or recurrence as assessed over a 1-year period from the start of treatment. The frequency and percentages of patients with a best overall response rate of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be determined. We will test the hypothesis that the ORR is greater than the null hypothesis of 10% using the Fisher's exact test.
Measure: Objective Response Rate (ORR) Time: Up to 1 yearSecondary Outcomes
Description: The DR for Complete Response (CR) and Partial Response (PR) will be measured from the date that the best response is first recorded until the date that PD is documented. For patients who continue treatment post progression, the date of Disease Progression (PD) documentation will be used for analysis. The DR will be summarized using descriptive statistics (N, mean, standard deviation, minimum, and maximum).
Measure: Duration of Response (DR) Time: Up to 4 yearsDescription: DCR will be defined as the percentage of patients who have achieved CR, PR, or SD for at least 12 weeks. The DCR will be summarized using descriptive statistics (N, mean, standard deviation, minimum, and maximum).
Measure: Disease Control Rate (DCR) According to RECIST Version 1.1 Criteria. Time: Up to 4 yearsDescription: PFS will be calculated as 1+ the number of days from the first dose of study drugs to documented radiographic progression or death due to any cause over a period of 1 year. For patients who continue treatment post-progression, the date of radiographic progression will be used for PFS analysis. For patients who continue treatment post-progression, the date of radiographic progression will be used for PFS analysis. The Kaplan-Meier analysis will be used to calculate the median PFS with 95% confidence interval.
Measure: Progression Free Survival (PFS) According to RECIST Version 1.1 Criteria. Time: Up to 1 yearDescription: OS will be calculated as 1+ the number of days from the first dose of study drugs to death due to any cause over a period of 1 year. The Kaplan-Meier analysis will be used to calculate the median OS with 95% confidence interval.
Measure: Overall Survival (OS) Time: Up to 1 year