NEW YORK – Addario Lung Cancer Medical Institute (ALCMI) on Wednesday launched a study exploring treatment resistance in patients with KRAS-mutant lung and other cancers.
ALCMI, a nonprofit research consortium, has partnered with patient advocacy organization GO2 for Lung Cancer to connect patients with the study, called SPARK. The group is also working with Dana-Farber Cancer Institute and Foundation Medicine on the study. The observational trial will enroll up to 500 participants with KRAS G12C-mutant tumors, such as colorectal or non-small cell lung cancer.
The SPARK study will enroll two cohorts: One will include patients who have progressed on a KRAS G12C inhibitor and need sequencing performed, and the second will include patients who have progressed on a KRAS G12C inhibitor but have already had a sequencing test. The second cohort will be invited to share their data and medical history with the study team.
For patients who need sequencing, the researchers will send blood collection kits to collect a liquid biopsy sample at their local hospital or clinic, which will then be sent to Dana-Farber. The samples will be tested on Foundation Medicine's FoundationOne Liquid Biopsy Assay to determine mechanisms of resistance. Patients treated with any KRAS G12C inhibitor, including Amgen's Lumakras (sotorasib) or Mirati's investigational adagrasib, can join the trial.
The researchers will explore differences in resistance mechanisms in patients with different tumor types and treated with different drugs. Researchers will follow participants to track the treatments they receive and their outcomes after they progress on the KRAS inhibitor and aim to identify a correlation between resistance mechanisms and clinical outcomes.
"The development of treatment resistance is unfortunately common in patients with lung cancers and other tumor types with the KRAS G12C mutation," Mark Awad, principal investigator of the study and director of clinical research at the Lowe Center for Thoracic Oncology at the Dana-Farber Cancer Institute, said in a statement. "The SPARK study seeks to learn more about this process so more effective and targeted treatments can be developed to help improve and extend the lives of patients."