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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03521154 | A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA) | PHASE3 | ACTIVE NOT_RECRUITING | 216 | — | — | Jul 19, 2018 | Oct 29, 2027 | May 5, 2026 | 118 | United States, Argentina +15 |
Time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy prior to progression, based on BICR assessment according to RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| Osimertinib | EXPERIMENTAL | Osimertinib (80mg or 40mg orally, once daily), in accordance with the randomization schedule. |
| Placebo Osimertinib | PLACEBO_COMPARATOR | Matching placebo for Osimertinib (80mg or 40mg orally, once daily), in accordance with the randomization schedule |
| Name | Type | Description |
|---|---|---|
| Osimertinib 80mg/40mg | DRUG | The initial dose of Osimertinib 80mg once daily can be reduced to 40mg once daily. Treatment can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met. |
| Placebo Osimertinib 80mg/40mg | DRUG | The initial dose of Placebo Osimertinib 80mg once daily can be reduced to 40mg once daily. Treatment can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met |
Inclusion Criteria 1. Male or female aged at least 18 years. 2. Patients with histologically documented NSCLC of predominantly non-squamous Pathology who present with locally advanced, unresectable (Stage III) disease (according to Version 8 of the International Association for the Study of Lung Ca...