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RECRUITING
NCT07554339
PHASE3

A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

Researchers are looking for new ways to treat locally advanced non-small cell lung cancer (NSCLC) that is unresected and has a gene mutation called KRAS G12C. Researchers want to learn if calderasib (MK-1084) can be given with durvalumab, an immunotherapy, to treat NSCLC after chemotherapy and radiation therapy. The goal of this trial is to learn if participants who receive calderasib and durvalumab live longer without the cancer growing or spreading compared to participants who receive placebo and durvalumab.

Official title: A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

310

Start Date

2026-06-18

Completion Date

2037-08-17

Last Updated

2026-06-26

Healthy Volunteers

No

Interventions

DRUG

Calderasib

Tablet for oral administration.

BIOLOGICAL

Durvalumab

Solution for intravenous (IV) infusion.

OTHER

Placebo to MK-1084

Placebo to MK-1084.

Locations (16)

NHO Revive Research Institute LLC ( Site 0118)

Lincoln, Nebraska, United States

Ajou University Hospital ( Site 2504)

Suwon, Kyonggi-do, South Korea

Keimyung University Dongsan Hospital ( Site 2503)

Daegu, Taegu-Kwangyokshi, South Korea

Severance Hospital, Yonsei University Health System ( Site 2501)

Seoul, South Korea

Asan Medical Center ( Site 2500)

Seoul, South Korea

National Cheng Kung University Hospital ( Site 2601)

Tainan, Taiwan

Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 2002)

Chernivtsi, Chernivetska Oblast, Ukraine

Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 2012)

Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine

Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 2006)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 2013)

Kropyvnytskyi, Kirovohrad Oblast, Ukraine

Ukrainian Center of Tomotherapy ( Site 2014)

Kropyvnytskyi, Kirovohrad Oblast, Ukraine

Shalimov Institute of Surgery and Transplantation ( Site 2003)

Kyiv, Kyivska Oblast, Ukraine

Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 2011)

Odesa, Odesa Oblast, Ukraine

ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2001)

Rivne, Rivne Oblast, Ukraine

Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 2004)

Vinnytsia, Vinnytsia Oblast, Ukraine

Volyn Regional Clinical Hospital ( Site 2010)

Lutsk, Volyn Oblast, Ukraine