Phase 3
N=256
T790M Plasma Testing Methodology Comparison and Clinical Validation
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02997501 ↗Enrolled (actual)
256
Serious AEs
—
Results posted
Mar 2024
Primary outcome: Primary: Concordance — 91.3; 66.8; 82.7; 86.1 percentage of aggrement
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- T790M+ Testing (Procedure); Baseline Visit Blood & Urine Testing (Procedure); Baseline ECG (Procedure); Visual Slit-Lamp Testing (Procedure); AZD9291 Dosing (Drug); Plasma AZD9291 testing (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concordance |
91.3; 66.8; 82.7; 86.1; 71.0; 88.3 | — |
| PRIMARY PFS Using Investigator Assessments According to RECIST v1.1 |
9.7; 10.6; 10.6; 9.7; 11.0; 10.5 | — |
| SECONDARY Testing Sensitivity, Specificity, PPV, NPV |
94.7; 90.5; 98.9; 98.9; 89.3; 52.5 | — |
| SECONDARY Overall Response Rate (ORR) |
56.3; 60.7; 62.4; 54.1; 62.0; 59.1 | — |
| SECONDARY 75% OS Duration |
9.7; 10.5; 10.7; 8.7; 11.9; 10.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent prior to any study specific procedures.
- Adults (according to China regulations for age of majority)
- Histological or cytological confirmed locally advanced NSCLC (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy.
- Patients who have progressed following prior therapy with an EGFR-TKI agent.
Exclusion Criteria
- Patients who disagree to participate this study.
- Patients whose medical objection was recorded to use the existing data from medical practice for scientific research.
Data sourced from ClinicalTrials.gov (NCT02997501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.