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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04003246 | Phase II Concurrent Durvalumab and Radiotherapy for for Stage III Non-Small Cell Lung Cancer | PHASE2 | COMPLETED | 10 | — | — | Apr 3, 2020 | Nov 5, 2024 | Mar 21, 2025 | 1 | United States |
To determine the 12-month progression-free survival (PFS) for Stage III non-small cell lung cancer patients treated with concurrent durvalumab and radiotherapy followed by consolidative durvalumab. PFS rate is based on an assessment by an investigator according to RECIST 1.1 criteria; PFS is defined as the time from the study enrollment to documented progressive disease or death due to any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Single Arm: Therapeutic Intervention | EXPERIMENTAL | All subjects receive the same therapeutic intervention of 1500mg intravenous durvalumab once every 4 weeks while receiving a 60 Gy/30 Fraction course of thoracic radiotherapy. After radiotherapy is complete, subjects continue to receive 1500mg intravenous durvalumab once every 4 weeks for up to one year following the start of treatment. |
| Name | Type | Description |
|---|---|---|
| Thoracic RT and Durvalumab | RADIATION | 1500mg every 4 weeks \[Q4W\] intravenous \[IV\], first dose within 3 days of RT initiation |
| Consolidative Durvalumab | DRUG | 1500mg every 4 weeks \[Q4W\] intravenous \[IV\] up to one year |
Inclusion Criteria: 1.1 Pathologically (histologically or cytologically) proven diagnosis of NSCLC with, medically inoperable (or patients who refuse resection) stage IIIA or stage IIIB disease (AJCC 8th edition); 1.1.1 Inoperable Stage IIIA disease is defined by multiple and/or bulky N2 mediastin...