Merck Initiates KANDLELIT-007, Phase 3 Clinical Trial Evaluating Calderasib, Investigational Oral KRAS G12C Inhibitor, In Combination With KEYTRUDA QLEX For Patients With KRAS G12C-Mutant, Advanced Or Metastatic Nonsquamous NSCLC

Third Phase 3 trial in Merck's KANDLELIT clinical development program, which is investigating calderasib in KRAS G12C-mutant cancers across multiple tumor types and treatment settings

Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced the initiation of KANDLELIT-007, a Phase 3 clinical trial evaluating calderasib (MK-1084), an investigational oral selective KRAS G12C inhibitor, in combination with KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) for the first-line treatment of patients with KRAS G12C-mutant, advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC).

This randomized, unblinded open-label, multicenter clinical trial (NCT07190248) will evaluate calderasib given orally once daily in combination with KEYTRUDA QLEX administered subcutaneously, compared with subcutaneous KEYTRUDA QLEX in combination with intravenous pemetrexed and chemotherapy (carboplatin or cisplatin), in newly diagnosed patients with KRAS G12C-mutant advanced or metastatic nonsquamous NSCLC. In both treatment arms, KEYTRUDA QLEX will be administered once every six weeks; in the comparator arm, pemetrexed will be given on days 1 and 22 of every three-week cycle and carboplatin or cisplatin will be given on days 1 and 22 for up to two three-week cycles.