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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04687241 | Almonertinib Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB Non-Small Cell Lung Cancer With EGFR-sensitive Mutations | PHASE3 | ACTIVE NOT_RECRUITING | 192 | — | — | Apr 30, 2021 | Jan 1, 2029 | Nov 7, 2024 | 1 | China |
DFS is defined as the time from randomization to the recurrence of tumor as assessed by IRC or death from any cause on study. The patients will receive long-term follow-up including chest and abdominal CT every 12 weeks during Year 1, then every 24 weeks during Years 2 to 5, and every 48 weeks during Year 6 and onwards; MRI/CT of brain, and bone scan performed every 48 weeks.
| Arm | Type | Description |
|---|---|---|
| Almonertinib | EXPERIMENTAL | - |
| Placebo Almonertinib | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Almonertinib | DRUG | The initial dose of Almonertinib 110 mg daily can be reduced to 55 mg daily under specific conditions. |
| Placebo Almonertinib | DRUG | Placebo Almonertinib |
Inclusion Criteria: * 1\. Provision of informed consent before any study-specific procedures, sampling and analyses. 2\. Male or female, age at least 18 years. 3. Histologically confirmed diagnosis of primary non-small lung cancer (NSCLC) on predominantly non-squamous histology. 4\. MRI or CT...