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

NCT04716946 Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	13
Start date	2021-01-27
Completion	2027-02

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

• Durvalumab
• Stereotactic Body Radiation Therapy

Primary outcomes

• Progression Free Survival — 2 years
  The primary objective of the study is to evaluate 2- year progression-free survival (PFS) per RECIST 1.1 with durvalumab combined with stereotactic body radiation therapy (SBRT) compared to historical controls with SBRT alone.

Countries

United States