140TiP KANDLELIT-007: Phase III, open-label study of first-line calderasib with subcutaneous pembrolizumab (pembro SC) vs pembro SC plus chemotherapy (chemo) for KRAS G12C– mutant advanced/metastatic nonsquamous NSCLC

The next-generation, selective KRAS G12C-GDP covalent inhibitor calderasib (MK-1084) demonstrated manageable safety and antitumor activity as monotherapy in previously treated disease and in combination with pembro ± chemo in KRAS G12C–mutant mNSCLC in the phase I KANDLELIT-001 study. MK-3475A is pembro and berahyaluronidase alfa (MK-5180), a variant of human hyaluronidase developed and manufactured by Alteogen Inc (Daejeon, South Korea) for SC administration. KANDLELIT-007 (NCT07190248) is a phase III study evaluating calderasib + pembro SC vs pembro SC + chemo in previously untreated KRAS G12C–mutant, nonsquamous mNSCLC.