SPRING 01 Trial
SPRING 01 will explore the safety and efficacy of the combination of a modulator of immune check point (avelumab), and two small molecule tyrosine kinase inhibitors (TKI) (axitinib and palbociclib).
During the Phase I, the tri-therapy will be tested at different doses following a specific dose-escalation scheme in order to establish the safety and identify the recommended dose for the Phase II. The Phase II will confirm the safety and will assess the clinical utility of the tri-therapy approach in the treatment of advanced/metastatic NSCLC.
The study will also explore the clinical utility of the Simplified Interventional Mapping System (SIMS), a new tool/algorithm enabling matching of NSCLC patients with combination therapies. For this purpose tumor/metastasis and matched normal tissue biopsies will be requested.
Patients eligible will have an advanced/metastatic NSCLC with no documented targetable alterations (EGFR, ROS1, MET exon 14 skipping mutation or ALK translocation) and will all receive the tri-therapy associating avelumab, axitinib and palbociclib.
FDA Okays WIN Consortium Trial to Test Three-Drug NSCLC Combo; Validate SIMS Algorithm
- Genomeweb, August 11, 2017
Launch of WIN SPRING Clinical Trial Press Conference at Avera Cancer Institute, Sioux Falls, USA
Avera To Enroll First Patients in Landmark Lung Cancer Tri-Therapy Clinical Trial
- CNBC Global Newswire, January 19, 2018
When my son died of cancer I decided to wage war on the disease myself
- Independent, November 9, 2017
Simplified Interventional Mapping System (SIMS)
- Oncotarget, April 3, 2015