drugset / Trial / NCT03523702
The Selective Personalized Radio-Immunotherapy for Locally Advanced NSCLC Trial
Phase 2
Completed
25 enrolled
Montefiore Medical Center
Henry Ford Cancer Institute · collabMerck Sharp & Dohme LLC · collabNew York University · collabUniversity of Michigan · collab
NaSingle-groupOpen-labelTreatment
Summary
The goal of this study is to explore if, for locally advanced non-small cell lung cancer patients whose tumors have high levels of PD-L1 (a marker associated with benefits from immunotherapy), a combination of immunotherapy and a personalized 4-week radiotherapy course could be more effective than standard treatment, which is a combination of chemotherapy and radiotherapy.
Timeline
- Start
- 2018-08-30
- Primary completion
- 2022-11-18
- Completion
- 2022-11-18
Outcome
Met primary endpoint
paper The 1-year PFS rate is 76%, satisfying our efficacy objective. PMID 37988638 ↗
Publications
- Results https://www.redjournal.org/article/S0360-3016(24)00859-9/fulltext
- Ohri N, Jolly S, Cooper BT, Kabarriti R, Bodner WR, Klein J, Guha C, Viswanathan S, Shum E, Sabari JK, Cheng H, Gucalp RA, Castellucci E, Qin A, Gadgeel SM, Halmos B. Selective Personalized RadioImmunotherapy for Locally Advanced Non-Small-Cell Lung Cancer Trial (SPRINT). J Clin Oncol. 2024 Feb 10;42(5):562-570. doi: 10.1200/JCO.23.00627. Epub 2023 Nov 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |