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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02511106 | AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy. | PHASE3 | ACTIVE NOT_RECRUITING | 682 | — | — | Oct 21, 2015 | Jan 31, 2029 | Mar 30, 2026 | 238 | United States, Australia +23 |
Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).
| Arm | Type | Description |
|---|---|---|
| AZD9291 | EXPERIMENTAL | AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule. |
| Placebo AZD9291 | PLACEBO_COMPARATOR | Matching placebo for AZD9291 (80 mg or 40 mg orally, once daily), in accordance with the randomization schedule. |
| Name | Type | Description |
|---|---|---|
| AZD9291 80 mg/40 mg | DRUG | The initial dose of AZD9291 80 mg once daily can be reduced to 40 mg once daily. |
| Placebo AZD9291 80 mg/40 mg | DRUG | The initial dose of Placebo AZD9291 80 mg once daily can be reduced to 40 mg once daily. |
| Open-label AZD9291 80 mg/40 mg | DRUG | Eligible patients will be offered open-label osimertinib upon recurrence and in the absence of intervening systemic anti-cancer therapy. |
Inclusion Criteria: 1. Male or female, aged at least 18 years. 2. Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology 3. MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care. 4. Patients must b...