SNPMiner Trials (Home Page)
Report for Mutation S786I
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 A Phase II, Open-Label, Multicenter, Single-Arm, Prospective Clinical Study to Investigate the Efficacy and Safety of Tislelizumab Combined With Chemotherapy in Non-squamous NSCLC With EGFR Sensitizing Mutation Who Failed EGFR TKI Therapy
A phase II, open-label, multicenter, single-arm, prospective clinical study to investigate the efficacy and safety of tislelizumab (anti-pd1 antibody) combined with chemotherapy in non-squamous non-small cell lung cancer patients with EGFR sensitizing mutation who failed EGFR TKI (Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor) therapy.
NCT04405674 Non Small Cell Lung Cancer Drug: Tislelizumab Drug: Carboplatin and Nab-paclitaxel Drug: Pemetrexed MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma
2. Documentation of tumor EGFR sensitizing mutation before EGFR TKI treatment, including 19del, L858R, G719X, S786I and L861Q. --- L858R --- --- S786I ---
Primary Outcomes
Description: Progression-free survival (per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first. Subjects who do not have disease progression will be censored at their last valid tumor assessment. PFS rate at 1 year as estimated by Kaplan-Meier method.
Measure: 1-Year Progression-Free Survival Rate (1-Year PFS Rate) Time: up to 24 months after enrollment or study closeSecondary Outcomes
Description: Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first.
Measure: Progression-Free Survival (PFS) Time: up to 24 months after enrollment or study closeDescription: ORR (per RECIST 1.1) is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR).
Measure: Objective Respond Rate (ORR) Time: up to 24 months after enrollment or study closeDescription: DCR (per RECIST 1.1) is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR), or stable disease (SD).
Measure: Disease Control Rate (DCR) Time: up to 24 months after enrollment or study closeDescription: OS is defined as the time from the starting date of study drug to the date of death due to any cause.
Measure: Overall Survival (OS) Time: up to 24 months after enrollment or study closeDescription: DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
Measure: Duration of Response (DoR) Time: up to 24 months after enrollment or study close