N/A
N=3,382
Asia Pacific and Russia Diagnostic Study for EGFR Testing
EGFR Mutation Status in aNSCLC Patients
Bottom Line
View on ClinicalTrials.gov: NCT01788163 ↗Enrolled (actual)
3,382
Serious AEs
—
Results posted
Mar 2016
Primary outcome: Primary: Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status — 59.2; 52.0; 77.4; 70.7 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EGFR mutation test (Genetic)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status |
59.2; 52.0; 77.4; 70.7; 71.3; 45.0 | — |
| PRIMARY Tumour EGFR Mutation by Subtype |
8; 1; 0; 0; 2; 0 | — |
| PRIMARY Tumour EGFR Mutation Status by Histology |
48.7; 88.9; 42.8; 83.6; 69.6; 100.0 | — |
| PRIMARY Overall Plasma EGFR Mutation Status |
79.3; 73.1; 86.9; 90.8; 20.7; 26.9 | — |
| PRIMARY Plasma EGFR Mutation by Subtype |
5; 0; 0; 0; 152; 35 | — |
| PRIMARY Plasma EGFR Mutation Status by Histology |
74.4; 93.2; 68.3; 90.2; 82.6; 100.0 | — |
| SECONDARY Concordance Rate of Comparison of Mutation Status Between Tumour and Plasma Samples |
77.6; 76.8; 83.6; 85.8 | — |
| SECONDARY Sensitivity and Specificity of Comparison of Mutation Status Between Tumour and Plasma Samples |
48.7; 97.1; 53.8; 97.9; 42.9; 95.7 | — |
| SECONDARY Predictive Values of Comparison of Mutation Status Between Tumour and Plasma Samples |
92.1; 73.6; 95.9; 69.7; 75.0; 84.9 | — |
| SECONDARY Tumour EGFR Mutation Testing |
1394; 271; 62; 60; 92; 101 | — |
| SECONDARY Tumour EGFR Mutation Testing Rates |
99.8; 100.0; 100.0; 96.7; 94.6; 99.0 | — |
| SECONDARY Tumour EGFR Mutation Testing Turnaround Time |
6.2; 7.4; 11.7; 12.9; 70.8; 8.4 | — |
| SECONDARY Plasma EGFR Mutation Testing |
1421; 271; 62; 950; 37; 0 | — |
| SECONDARY Plasma EGFR Mutation Testing Rates |
100.0; 100.0; 98.4; 99.1; 20.7; 26.9 | — |
| SECONDARY Plasma EGFR Mutation Testing Turnaround Time |
39.8; 26.7; 18.1; 90.1 | — |
| SECONDARY Demographics and Disease Characteristics by Tumour EGFR Mutation Status |
952; 1297; 89; 838; 705; 647 | 0.0001 sig |
| SECONDARY Time Since First Non-small-cell Lung Carcinoma (NSCLC) Diagnosis by Tumor EGFR Mutation |
2.6; 2.6 | — |
| SECONDARY Number of Organs With Metastasis by Tumour EGFR Mutation Status |
1.8; 1.6 | — |
| SECONDARY Demographics and Disease Characteristics by Plasma EGFR Mutation Status |
397; 1417; 60; 794; 298; 835 | 0.0009 sig |
| SECONDARY Time Since First NSCLC Diagnosis by Plasma EGFR Mutation |
2.2; 3.0 | — |
| SECONDARY Number of Organs With Metastasis by Plasma EGFR Mutation Status |
2.1; 1.6 | — |
| SECONDARY First Line Treatment Choice by Asia Pacific Country |
1151; 218; 44; 45; 65; 87 | — |
| SECONDARY First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status |
499; 652; 122; 96; 12; 32 | — |
Summary
Interventional diagnostic, international, multicenter and non-comparative study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies. It will be conducted in Asia Pacific and Russia and will assess the current status of EGFR mutation testing, and the concordance of EGFR mutation status derived from tumour samples and blood based circulating free DNA.
Eligibility Criteria
Inclusion Criteria
- Histological or cytological confirmed locally advanced NSCLC (stage IIIA/B) not suitable for curative treatment or metastatic (stage IV) NSCLC
- Newly diagnosed patients with locally advanced and/or metastatic NSCLC who are systemic treatment Naive (i.e. no chemotherapy or EGFR-TKI) or patients with recurrent disease who have previously received adjuvant chemotherapy (not including EGFR-TKI)
- Provision of diagnostic cancer tissue or cytology sample upon inclusion (surgical specimen, biopsy sample, or cytology sample is acceptable) and Provision of a routine blood (plasma) sample in China, Russia, Taiwan and Korea
- Patients aged 18 years and older
Exclusion Criteria
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study
- Pregnancy or breast-feeding
Data sourced from ClinicalTrials.gov (NCT01788163). 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.