KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations
Summary
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.
Arms & interventions
- DrugMK-1084
Oral Administration
- BiologicalPembrolizumab
Intravenous administration
- BiologicalCetuximab
Intravenous administration
- DrugCarboplatin
Intravenous administration
- DrugPemetrexed
Intravenous administration
Outcome measures
Primary
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
Secondary
Duration of Response (DOR) per RECIST 1.1 as assessed by BICR
Time frame: Up to approximately 84 months
Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR
Time frame: Up to approximately 84 months
Overall Survival (OS)
Time frame: Up to approximately 84 months
Area Under the Concentration-Time Curve (AUC) for MK-1084
Time frame: At designated timepoints (up to approximately 44 days)
Maximum Concentration (Cmax) of MK-1084
Time frame: At designated timepoints (up to approximately 44 days)
Trough Concentration (Ctrough) of MK-1084
Time frame: At designated timepoints (up to approximately 84 months)
Eligibility criteria
Study locations (3)
Clermont Oncology Center ( Site 0041)
Clermont, Florida, 34711
Sanford Health Roger Maris Cancer Center ( Site 0039)
Fargo, North Dakota, 58102
Sanford Cancer Center Oncology Clinic ( Site 0038)
Sioux Falls, South Dakota, 57104