Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02997501 | T790M Plasma Testing Methodology Comparison and Clinical Validation | PHASE3 | COMPLETED | 256 | — | — | Dec 23, 2016 | Oct 24, 2018 | Mar 4, 2024 | 7 | China |
| NCT02474355 | Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC | PHASE3 | COMPLETED | 3,017 | — | — | Sep 18, 2015 | Apr 18, 2019 | Nov 11, 2021 | 201 | Argentina, Australia +14 |
To evaluate concordance of T790M plasma mutation testing between the Cobas test and each of other platforms: Super-ARMS, digital PCR or NGS.
To assess the efficacy of AZD9291 monotherapy by assessment of PFS in adult patients with advanced or metastatic NSCLC, who have received prior EGFR- TKI therapy and are T790M mutation positive detected by any one of the four plasma testing platforms. PFS was defined using Response Evaluation Criteria In Solid Tumors version 1.1(RECIST v1.1).
OS was defined as the time, in months from the date of first dose of Osimertinib until death due to any cause, or at last documented contact with participant status "alive" (in this study any participants alive at study discontinuation, or lost to follow-up was considered being censored at study discontinuation date or at the last known date participant was alive). OS was summarized using a Kaplan-Meier (KM) estimate of the median time to death or censoring together with their 95% confidence intervals.
Safety assessment of Osimertinib was analyzed by evaluating AEs and SAEs.
| Arm | Type | Description |
|---|---|---|
| AZD9291 | EXPERIMENTAL | Single arm of AZD9291, starting dose of 80mg |
| Name | Type | Description |
|---|---|---|
| T790M+ Testing | PROCEDURE | The patient will need to have T790M+ testing |
| Baseline Visit Blood & Urine Testing | PROCEDURE | Blood count and standard chemistry testing to ensure patient meets inclusion/exclusion criteria |
| Baseline ECG | PROCEDURE | ECG to ensure absence of any cardiac abnormality |
| Visual Slit-Lamp Testing | PROCEDURE | Slit-lamp testing performed to ensure patients do not have any eye abnormalities or symptoms |
| AZD9291 Dosing | DRUG | Patients to be provided with AZD9291 every 6 weeks (+/- 7 days) |
| Plasma AZD9291 testing | PROCEDURE | The patient will need to have plasma AZD9291 testing before treatment |
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures. 2. Adults (according to China regulations for age of majority) 3. Histological or cytological confirmed locally advanced NSCLC (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery o...