At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Detect EGFR T790M Mutation in ctDNA of Chinese Advanced/Metastatic NSCLC Patients by Cobas, Super-ARMS, Digital PCR and NGS and Evaluate Clinical Outcomes of T790M Mutation Positive Patients Who Had AZD9291 Monotherapy
In Brief
A Phase 3 clinical trial evaluating T790M+ Testing, Baseline Visit Blood & Urine Testing, and 4 other interventions for Lung Cancer. Completed, enrolled 256 participants across 7 sites.
Detailed Summary
The aim of this study is to evaluate concordance of T790M mutation plasma testing between the Cobas test and each of other platforms: Super-ARMS, digital PCR or NGS. And to assess the efficacy of AZD9291 monotherapy by assessment of PFS in adult patients with advanced or metastatic NSCLC, who have received prior EGFR-tyrosine kinase inhibitor (TKI) therapy and are T790M mutation positive detected by any one of the four plasma testing platforms: Cobas/Super-ARMS/ digital PCR/NGS.
Study Details
Timeline
Interventions
The patient will need to have T790M+ testing
Blood count and standard chemistry testing to ensure patient meets inclusion/exclusion criteria
ECG to ensure absence of any cardiac abnormality
Slit-lamp testing performed to ensure patients do not have any eye abnormalities or symptoms
Patients to be provided with AZD9291 every 6 weeks (+/- 7 days)
The patient will need to have plasma AZD9291 testing before treatment