Durvalumab and Stereotactic Radiotherapy for Advanced NSCLC
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Non -Small Cell Lung Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: We hypothesize that Durvalumab and stereotactic radiotherapy, in the form of PULSAR and SAbR, and durvalumab will confer a 60% increase in improvement in quality of life over the historical control rate of 33%, for an absolute improvement of 27%. Using a two-sided exact binomial test with a two-sided significance level of 0.1 and 80% power, we estimate that we will need to enroll 23 patients per arm do detect a difference. Accounting for 10% attrition, we will plan to enroll 52 patients.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04786093
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Dat Vo, MD UT Southwestern Medical Center
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