drugset / Trial / NCT03275597

Phase Ib Study of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Non-small Lung Cancer (NSCLC) With Dual Immune Checkpoint Inhibition

NCT03275597

NaSingle-groupOpen-labelTreatment

Summary

This is a phase Ib study to evaluate safety and tolerability of dual checkpoint inhibition (DCI) of durvalumab (anti-PD-L1) and tremelimumab (anti-CTLA-4) with SBRT in the treatment of oligometastatic NSCLC. This study will examine the sequential delivery of SBRT to all disease sites followed by combination of durvalumab and tremelimumab for patients for whom the goal is ablating all known sites of disease. The investigators anticipate that for many participants this will be the first line-therapy. Participants who have received prior-platinum-based chemotherapy and/or any line of prior chemotherapy are eligible. Prior immunotherapy treatment is not allowed.

Timeline

Start
2018-02-20
Primary completion
2020-07-01
Completion
2020-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 20 mg/kg Other
Subject Durvalumab Monoclonal antibody 1500 mg Other
Subject Tremelimumab Monoclonal antibody 4 mg/kg Other
Subject Tremelimumab Monoclonal antibody 300 mg Other