NCT04716946

Treating Early-stage Non-Small Cell Lung Cancer With Durvalumab and Radiation Therapy

Stereotactic Body Radiation Therapy With Consolidation Durvalumab in High-Risk Early-Stage Non-Small Cell Lung Cancer - A Phase II Single-Arm Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether treatment with the study drug durvalumab combined with a type of radiation therapy called stereotactic body radiation (SBRT) is a more effective treatment for early-stage non-small cell lung cancer (NSCLC) than SBRT alone.

Conditions

• NSCLC
• Non-small Cell Lung Cancer
• Lung Cancer
• Non-small Cell Lung Cancer Stage I
• Non-small Cell Lung Cancer Stage II
• Non-small Cell Lung Cancer Stage III
• Non-small Cell Lung Cancer Stage IIIA
• PD-L1 Gene Mutation

Interventions

Type	Name	Description
DRUG	Durvalumab	Patients will receive durvalumab 1500mg durvalumab via IV infusion over 1 hour, once every 4 weeks (Q4W) for up to a maximum of 6 months (up to 6 doses/cycles) unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
RADIATION	Stereotactic Body Radiation Therapy	Radiation therapy will be performed with external beam ionizing radiation in accordance with institutional standard practice. 3D conformal radiation therapy (3D-CRT), intensity-modulated radiation therapy (IMRT) or volumetric arc therapy (VMAT) will be used at the discretion of the treating radiation oncologist.

Timeline

• Start date: 2021-01-27
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2021-01-20
• Last updated: 2026-03-04

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study