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.
Has a histological or cytological diagnosis of locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology.
Has completed definitive platinum-based concurrent chemoradiotherapy (CCRT) prior to enrollment, without disease progression.
Has provided a tumor tissue sample for central laboratory testing of Kirsten rat sarcoma G12C (KRAS G12C) status, programmed cell death ligand 1 (PD-L1) status, and biomarker research.
Tumor tissue sample has a demonstrated presence of KRAS G12C mutation and an evaluable PD-L1 status result.
Has a diagnosis of small cell lung cancer or mixed tumors with small cell elements.
Has a gastrointestinal disorder affecting absorption or is unable to swallow orally administered medication.
Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease.
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
Parallel
Calderasib
DrugTablet for oral administration.
Durvalumab
Biological/VaccineSolution for intravenous (IV) infusion.
Placebo to MK-1084
Other interventionPlacebo to MK-1084.
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Number of Participants Who Experience an Adverse Events (AEs)
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experience an AE will be presented.
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinue study treatment due to an AE will be presented.
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
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