Merck Launches Phase 3 Trial of Calderasib with KEYTRUDA QLEX for Advanced NSCLC

Trial Overview

Merck has initiated the KANDLELIT-007 Phase 3 clinical trial to evaluate calderasib (MK-1084), an investigational oral KRAS G12C inhibitor, in combination with KEYTRUDA QLEX for first-line treatment of patients with KRAS G12C-mutant, advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC).

Study Design

This randomized, unblinded open-label, multicenter trial will compare calderasib and subcutaneous KEYTRUDA QLEX with a combination of subcutaneous KEYTRUDA QLEX, intravenous pemetrexed, and chemotherapy (carboplatin or cisplatin) in newly diagnosed patients. KEYTRUDA QLEX will be administered every six weeks in both arms, while pemetrexed and chemotherapy will follow a specific schedule in the comparator arm.

Endpoints and Enrollment

The trial aims to enroll approximately 675 patients globally. The primary endpoint is progression-free survival (PFS) in patients whose tumors express PD-L1 (tumor proportion score ≥1%). Secondary endpoints include PFS in all participants, overall survival, response rate, duration of response, and safety.

Additional Trials

Calderasib is also being investigated in other Phase 3 trials, including KANDLELIT-012 for colorectal cancer and KANDLELIT-004 for NSCLC with high PD-L1 expression. Additionally, Phase 1 and Phase 2 trials are assessing calderasib's safety, tolerability, and efficacy as monotherapy and in combination therapies for KRAS G12C-mutant advanced solid tumors.

Collaboration

Calderasib's development involves collaboration with Taiho Pharmaceutical Co. Ltd. and Astex Pharmaceuticals, a subsidiary of Otsuka Pharmaceutical Co., Ltd.