SIOUX FALLS, S.D., Sept. 6 Avera Health, an integrated health system, issued the following news:
Avera will be one of eight sites in the world participating in a groundbreaking new clinical trial for first-line treatment of metastatic non-small cell lung cancer.
The clinical trial is part of the Worldwide Innovative Networking (WIN) Consortium and recently received U.S. Food and Drug Administration (FDA) approval to move ahead with clinical trials. It is the latest in several planned trials to be offered at Avera, which will improve patient access to cutting edge clinical research in the Sioux Falls region.
"This win for Sioux Falls is two-fold: it's a good opportunity for patients who have advanced lung cancer but is also a sign of hope for the future. What we learn from these studies can be very important for treatments down the road," said Benjamin Solomon, MD, the lead investigator for the study at Avera and medical oncologist with Avera Cancer Institute.
The Survival Prolongation by Rationale Innovative Genomics (SPRING) trial will have strict enrollment protocols aimed at patients who are usually offered first-line platinum-based chemotherapy.
More than 60 percent of non-small cell lung cancer cases are detected in an advanced stage, and less than 5 percent of patients are alive at five years after diagnosis. A paradigm-changing strategy for treating the deadliest cancer is needed.
Patients will be provided a three-drug protocol that incorporates immunotherapy (avelumab) and two other therapies (palbociclib and axitinib). These three targeted drugs used in combination are expected to be highly potent, whereas used alone they produce a modest clinical outcome. A similar concept is used in the treatment of AIDS and tuberculosis, but to be effective for cancer the combination must be much more tailored to the patient.
The trial will further results from WIN's first clinical trial and validate a novel algorithm SIMS (Simplified Interventional Mapping System) developed to match each patient's tumor biology to a specific drug combination. For this purpose, both tumor and normal lung tissue biopsies will be obtained from patients during the SPRING trial.
This collaboration puts Avera at the table with major cancer centers from around the world poised to develop and conduct trailblazing trials within cancer care.
"Avera must have a high level of expertise to perform these studies," Solomon said. "This is a testament to the level of ingenuity and knowledge Avera patients have access to. This is not something that can be done everywhere."
SPRING's investigator-initiated research will be led by Razelle Kurzrock, MD, (University of California San Diego, Moores Cancer Center) and co-led by Enriqueta Felip, MD, (Vall d'Hebron Institute of Oncology) and will be launched in five countries and eight WIN member sites, including two in the U.S.
"It is very exciting to see this endeavor becoming more concrete and this unprecedented cooperation materializing. We are looking forward to the activation of our clinical sites," said Kurzrock, trial global coordinator, and Head of WIN Clinical Trials Committee. ''WIN has the potential and expertise to test other combinations and has the technologies needed to match patients' tumor biology profile with the appropriate combination."
The SPRING trial will start with a Phase I portion to explore the safety of the combination and determine the optimal doses for Phase II that will explore the efficacy of this tri-therapy regimen in first-line treatment of metastatic non-small cell lung cancer. The trial will have strict eligibility criteria and limited enrollment.