drugset / Trial / NCT03275597
Phase Ib Study of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Non-small Lung Cancer (NSCLC) With Dual Immune Checkpoint Inhibition
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |