Researchers want to learn if using a study medicine called MK-1084 can help treat NSCLC. MK-1084 is a type of treatment called targeted therapy for the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C gene change. The goal of this study is to learn about the safety of MK-1084 and to learn how many people have the cancer get smaller or go away during the study treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
130
Oral Administration
Intravenous administration
Intravenous administration
Intravenous administration
Intravenous administration
Clermont Oncology Center ( Site 0041)
Clermont, Florida, United States
RECRUITINGSanford Health Roger Maris Cancer Center ( Site 0039)
Fargo, North Dakota, United States
RECRUITINGSanford Cancer Center Oncology Clinic ( Site 0038)
Sioux Falls, South Dakota, United States
RECRUITINGKuopion Yliopistollinen Sairaala ( Site 0261)
Kuopio, Northern Savonia, Finland
RECRUITINGHYKS Syöpätautien klinikka ( Site 0260)
Helsinki, Uusimaa, Finland
RECRUITINGDeventer Ziekenhuis ( Site 0272)
Deventer, Overijssel, Netherlands
RECRUITINGLeids Universitair Medisch Centrum ( Site 0273)
Leiden, South Holland, Netherlands
RECRUITINGSeverance Hospital Yonsei University Health System ( Site 0080)
Seoul, South Korea
RECRUITINGHacettepe Universite Hastaneleri ( Site 0140)
Ankara, Turkey (Türkiye)
RECRUITINGCOMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0139)
Cherkasy, Cherkasy Oblast, Ukraine
RECRUITING...and 8 more locations
Percentage of Participants with a Dose Limiting Toxicity (DLT)
A DLT is defined as the occurrence of protocol-specified toxicities if assessed by the investigator to be possibly, probably, or definitely related to study intervention administration, excluding toxicities clearly not related to the drug.
Time frame: Up to approximately 21 days
Percentage of Participants who Experience at Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 84 months
Percentage of Participants who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 84 months
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by Blinded Independent Central Review (BICR)
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
Time frame: Up to approximately 84 months
Duration of Response (DOR) per RECIST 1.1 as assessed by BICR
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Time frame: Up to approximately 84 months
Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Time frame: Up to approximately 84 months
Overall Survival (OS)
OS, defined as the time from first dose or randomization (depending on study period) to death due to any cause. OS will be presented.
Time frame: Up to approximately 84 months
Area Under the Concentration-Time Curve (AUC) for MK-1084
Blood samples will be collected to determine the AUC of MK-1084.
Time frame: At designated timepoints (up to approximately 44 days)
Maximum Concentration (Cmax) of MK-1084
Blood samples will be collected to estimate Cmax of MK-1084.
Time frame: At designated timepoints (up to approximately 44 days)
Trough Concentration (Ctrough) of MK-1084
Blood samples will be collected to determine the Ctrough of MK-1084.
Time frame: At designated timepoints (up to approximately 84 months)
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