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.

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Journal
ESMO Open
Published
2026-03-17
DOI
https://doi.org/10.1016/j.esmoop.2026.106447
Primary Topic
Protease and Inhibitor Mechanisms
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article
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article

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

Renata Eiras, M. Erman, Vito Barbieri, M.J. Hochmair et al.
ESMO Open
Protease and Inhibitor Mechanisms
article

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

Renata Eiras, M. Erman, Vito Barbieri, M.J. Hochmair, Brett Hughes, Samuel Deshayes, G.F. Ho, N.D. Robinson, J. Zhao, J. Wu, J. Bar, A. Ogino, G. Lazaridis, E.H.C.E.S. Cronenberg, M. Schenker, M. Provencio Pulla, M.C. Evangelist, T. Kurata, J.R. Rodriguez Cid, J.C-H. Yang
article en

Abstract

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.

ESMO OpenVol. 11
Kansai Medical University (JP), Merck & Co., Inc., Rahway, NJ, USA (United States) (US), Aristotle University of Thessaloniki (GR), Sheba Medical Center (IL), Cancer Institute (WIA) (IN), University of Malaya (MY), Papageorgiou General Hospital (GR), Hospital Universitario Puerta de Hierro Majadahonda (ES), Centre Hospitalier Universitaire de Caen Normandie (FR), Hacettepe University Hospital (TR), New York Oncology Hematology (US), National Taiwan University Hospital (TW), Azienda Ospedaliero-Universitaria "Renato Dulbecco" (IT), Ministry of Education (ET), Cancer Care Services (US), Instituto Nacional de Cancerología (MX), Centro de Pesquisas Oncológicas (BR), UConn Health (US), Université de Caen Normandie (FR)
Openalex Percentile: Top 19%
Protease and Inhibitor Mechanisms
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