NCT03916419

Magnetic Resonance-Guided Hypofractionated Adaptive Radiation Therapy With Concurrent Chemotherapy and Consolidation Durvalumab for Inoperable Stage IIB, IIIA, and Select IIIB and IIIC Non-small Cell Lung Cancer

A Single-Arm Phase II Study With a Safety Lead-in of Magnetic Resonance-Guided Hypofractionated Adaptive Radiation Therapy With Concurrent Chemotherapy and Consolidation Durvalumab for Inoperable Stage IIB, IIIA, and Select IIIB and IIIC Non-small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Building upon the clinical experience of the investigators with the magnetic resonance (MR)-guided radiation therapy system and applying principals of hypofractionation toward the current treatment paradigm of concurrent chemoradiation and consolidation immunotherapy for locally advanced non-small cell lung cancer (NSCLC), this prospective, single-arm Phase II clinical trial with safety lead-in will test the feasibility and outcomes of this approach.

Conditions

• Stage IIB Non-Small Cell Lung Cancer
• Stage IIIA Non-small Cell Lung Cancer
• Stage IIIB Non-small Cell Lung Cancer
• Stage IIIC Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DEVICE	ViewRay MR-Linear Accelerator	-Radiation will be delivered by this machine
RADIATION	Radiation therapy	-60Gy in 15 fractions
DRUG	Paclitaxel	-50 mg/m\^2 intravenous
DRUG	Carboplatin AUC	-2 mg/mL/min intravenous over 30 minutes
BIOLOGICAL	Durvalumab	-10 mg/kg

Timeline

• Start date: 2019-06-20
• Primary completion: 2025-09-28
• Completion: 2025-09-28
• First posted: 2019-04-16
• Last updated: 2025-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study