The purpose of this study is to evaluate the efficacy and safety of olmutinib 600 mg QD in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).
Name: Olmutinib
Description: Defined as a best overall confirmed response of either CR or PR according to the RECIST version 1.1
Measure: Objective response rate (ORR) Time: 24 monthsDescription: Defined as the proportion of patients with a documented CR, PR, and SD during the treatment cycles according to the RECIST version 1.1
Measure: Disease control rate (DCR) Time: 24 monthsDescription: Defined as the interval between the date of the first observation of tumor response (CR or PR) and the date of disease progression or death
Measure: Duration of overall tumor response (DR) Time: 24 monthsDescription: Defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first
Measure: Progression-free survival (PFS) Time: 24 monthsDescription: Defined as the time from first administration of study drug to determination of tumor progression by RECIST version 1.1
Measure: Time to progression (TTP) Time: 24 monthsAllocation: N/A
Single Group Assignment
There are 3 SNPs
- At least one documented EGFR mutation which is known to be related with susceptibility to EGFR-TKIs (including G719X, exon 19 deletion, L858R, and L861Q). --- L858R ---
- At least one documented EGFR mutation which is known to be related with susceptibility to EGFR-TKIs (including G719X, exon 19 deletion, L858R, and L861Q). --- L858R --- --- L861Q ---
A Single-arm, Open-label, Phase 1b Study Evaluating the Efficacy and Safety of Olmutinib 600 mg QD in Patients With T790M-positive NSCLC After Treatment With an EGFR-TKI. --- T790M ---
Olmutinib 600 mg QD in Patients With T790M-positive NSCLC After Treatment With an EGFR-TKI The purpose of this study is to evaluate the efficacy and safety of olmutinib 600 mg QD in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). --- T790M ---
Olmutinib 600 mg QD in Patients With T790M-positive NSCLC After Treatment With an EGFR-TKI The purpose of this study is to evaluate the efficacy and safety of olmutinib 600 mg QD in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). --- T790M --- --- T790M ---
- Centrally confirmed T790M mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen. --- T790M ---
Non Small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung This is a single-arm, open-label, Phase 1b study to evaluate the efficacy and safety of oral single agent olmutinib administered to patients with T790M-positive NSCLC after treatment with an EGFR-TKI. --- T790M ---