Safety and Efficacy of Consolidative Hypofractionated Radiation Therapy (hfRT) for Boosting the Residual Primary Lung Cancer With Durvalumab
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Carcinoma Non-small-cell Lung
- Lung Cancer
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Both males and females
Description
For safety reasons, consolidative hfRT will start from 6.5Gy x 2 fractions and dose escalate to 10Gy x 2 fractions in a 3+3 design. Consolidative hfRT will be delivered one to two months after finishing definitive chemoradiation therapy (dCRT) and concurrently with adjuvant anti-PD-L1 therapy using ...
For safety reasons, consolidative hfRT will start from 6.5Gy x 2 fractions and dose escalate to 10Gy x 2 fractions in a 3+3 design. Consolidative hfRT will be delivered one to two months after finishing definitive chemoradiation therapy (dCRT) and concurrently with adjuvant anti-PD-L1 therapy using durvalumab in stage III non-small cell lung cancer (NSCLC). At the final determined consolidative hfRT dose level, a total of thirty-two subjects with pathologically documented stage III NSCLC treated with dCRT will be enrolled for data analyses. Follow-up assessments will occur every 3 months during durvalumab therapy for the first two years, then every 4-6 months after 2 years from study registration until confirmed disease progression or death. Primary endpoints include the safety of boost hfRT and concurrent anti-PD-L1 therapy adjuvantly following dCRT, and the 12-month progression-free survival to compare with historical results.
Tracking Information
- NCT #
- NCT04748419
- Collaborators
- AstraZeneca
- Investigators
- Principal Investigator: Chi Zhang, MD, PhD University of Nebraska