Phase II Concurrent Durvalumab and Radiotherapy for for Stage III Non-Small Cell Lung Cancer
Part of paid clinical trials in Dallas, Texas.
- Sponsor
- University of Texas Southwestern Medical Center
- Study ID
- NCT04003246
- Phase
- PHASE2
- Status
- Completed
Conditions
- Lung Cancer Stage III
- Non Small Cell Lung Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Thoracic RT and Durvalumab — RADIATION1500mg every 4 weeks \[Q4W\] intravenous \[IV\], first dose within 3 days of RT initiation
- Consolidative Durvalumab — DRUG1500mg every 4 weeks \[Q4W\] intravenous \[IV\] up to one year
Study Details
Single arm, Phase II trial of concurrent Durvalumab (MEDI 4736) and radiotherapy followed by consolidative Durvalumb (MEDI 4736) for Stage III Non-Small Cell Lung Cancer (NSCLC)
Key Dates
- Start date
- Apr 3, 2020
- Status verified
- Mar 2025
- Primary completion
- Jun 15, 2022
- Completion
- Nov 5, 2024
Study Design
- Enrollment
- 10 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Single Arm: Therapeutic InterventionAll 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.
Primary Outcome Measure
12-Month Progression-free Survival (PFS) Time [ Time Frame: Twelve months from the study enrollment ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | 75390 | - |
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