Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.
Part of paid clinical trials in Long Beach, California.
- Sponsor
- AstraZeneca
- Study ID
- NCT04642469
- Phase
- PHASE3
- Status
- Completed
Conditions
- Carcinoma, Non- Small Cell Lung
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 130 Years
- Healthy Volunteers
- Not accepted
Interventions
- Durvalumab — DRUGIntravenous administration of Durvalumab
- Placebo — OTHERPlacebo Comparator
Study Details
This is a Phase III double-blind, placebo-controlled study of Durvalumab versus Placebo in patients with stage II-III NSCLC who are MRD-positive following curative intent therapy.
Key Dates
- Start date
- Nov 30, 2020
- Status verified
- May 2024
- Primary completion
- May 31, 2023
- Completion
- Jan 15, 2024
Study Design
- Enrollment
- 30 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: DurvalumabIntravenous administration of Durvalumab
- Placebo Comparator: PlaceboIntravenous administration of placebo
Primary Outcome Measure
Disease-free Survival (DFS) [ Time Frame: Every 8 weeks (q8w) ± 1 week until Week 48, then every 12 weeks (q12w) ± 1 week until appearance of RECIST 1.1-defined disease recurrence or follow-up, up to 16.6 months ]
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Long Beach | California | 90806 | - |
| Research Site | Los Angeles | California | 90089 | - |
| Research Site | Daytona Beach | Florida | 32117 | - |
| Research Site | Gainesville | Florida | 32605 | - |
| Research Site | Punta Gorda | Florida | 33980 | - |
| Research Site | Louisville | Kentucky | 40241 | - |
| Research Site | Minneapolis | Minnesota | 55404 | - |
| Research Site | Spartanburg | South Carolina | 29303 | - |
| Research Site | Nashville | Tennessee | 37203 | - |
| Research Site | Salt Lake City | Utah | 84112 | - |