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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02454933 | Study of AZD9291 Plus MEDI4736 Versus AZD9291 Monotherapy in NSCLC After Previous EGFR TKI Therapy in T790M Mutation Positive Tumours | PHASE3 | COMPLETED | 29 | — | — | Jul 15, 2015 | Jun 21, 2023 | Sep 19, 2024 | 13 | Canada, South Korea +1 |
As a measure of the safety and tolerability of osimertinib in combination with durvalumab the number of subjects who experienced any treatment emergent AE (TEAE), any causally related AE, any serious AE (SAE), and any causally related SAE are presented.
| Arm | Type | Description |
|---|---|---|
| MEDI4736 & AZD9291 Combination | EXPERIMENTAL | 10mg/kg q2w (IV) infusion \& once daily tablet 80 mg |
| AZD9291 Monotherapy | EXPERIMENTAL | Once daily tablet 80 mg |
| Name | Type | Description |
|---|---|---|
| AZD9291 | DRUG | Once daily tablet 80 mg |
| MEDI4736 | DRUG | 10mg/kg q2w (IV) infusion |
Inclusion Criteria: * Aged at least 18 years. Japan patients aged at least 20 years. * Locally advanced/metastatic NSCLC, not amenable to curative surgery or radiotherapy * Confirmation from a previous archival sample that the tumour harbours an EGFR mutation known to be associated with EGFR TKI se...