Dr. Weiss on the Design of the KRYSTAL-10 Trial in KRAS G12C-Mutated CRC

Jared Weiss, MD, associate professor of medicine, Division of Oncology, Department of Medicine, University of North Carolina (UNC) School of Medicine, associate director of finance, UNC Lineberger Clinical Protocol Office, UNC Lineberger Comprehensive Cancer Center, discusses ​the design of the phase 3 KRYSTAL-10 trial (NCT04793958) in KRAS G12C-mutated unresectable or metastatic colorectal cancer (​mCRC).

The phase 1/2 KRYSTAL-1 study (NCT03785249) led to the development of the phase 3 KRYSTAL-10 trial, a randomized, open-label study evaluating adagrasib (MRTX849) plus cetuximab (Erbitux) in the second-line setting compared with chemotherapy for patients with mCRC harboring KRAS G12C mutations, Weiss explains. Patients, who will have had previous progression on fluoropyrimidine doublets in the frontline setting, will be randomized to adagrasib plus cetuximab or a fluoropyrimidine doublet they were not previously exposed to, Weiss says.

Moreover, anti­–VEGF or VEGF receptor therapy will be allowed in the comparator arm per investigator discretion, Weiss continues. The study is planned to accrue patients from about 300 sites in Europe and Asia; sites in the United States have already begun accrual, Weiss concludes.