KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations
Summary
Researchers want to learn if MK-1084, the study medicine, can treat advanced or metastatic non-squamous NSCLC. MK-1084 is a targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread. The goals of this study are to learn: * About the safety of MK-1084 and if people tolerate it when taken with other treatments * How many people have the cancer respond (get smaller or go away) to the treatments
Detailed description
This is a substudy of the master protocol MK-3475-U01 (KEYMAKER-U01) - NCT04165798.
Arms & interventions
- DrugMK-1084
Oral administration
- BiologicalPatritumab deruxtecan
IV infusion
- BiologicalSacituzumab tirumotecan
IV Infusion
- BiologicalCetuximab
IV Infusion
- DrugRescue Medications
Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent) for prevention of chemotherapy induced nausea and vomiting.
Outcome measures
Primary
Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
DLT will be defined as any drug-related AE observed during the DLT evaluation period (up to 42 days) that results in a change to a given dose or a delay in initiating the next treatment.
Time frame: Up to 42 days
Number of Participants Who Experience an 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. The number of participants that experience AEs will be reported.
Time frame: Up to approximately 65 months
Number of Participants Who Discontinue Study Treatment 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. The number of participants that discontinue study intervention due to an AE will be reported.
Time frame: Up to approximately 64 months
Objective Response Rate (ORR)
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 Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Time frame: Up to approximately 65 months
Secondary
Duration of Response (DOR)
Time frame: Up to approximately 65 months
Progression-Free Survival (PFS)
Time frame: Up to approximately 124 months
Area Under the Curve From Time 0 to the End of the Dosing Interval (AUC tau)
Time frame: Predose and at designated time points post-dose (up to approximately 65 months)
Maximum Plasma Concentration (Cmax)
Time frame: Predose and at designated time points post-dose (up to approximately 65 months)
Minimum Observed Concentration (Ctrough)
Time frame: Predose and at designated time points post-dose (up to approximately 65 months)
Eligibility criteria
Study locations (4)
Clermont Oncology Center ( Site 0041)
Clermont, Florida, 34711
University of Illinois Hospital & Health Sciences System ( Site 0044)
Chicago, Illinois, 60612
Providence Portland Medical Center ( Site 0043)
Portland, Oregon, 97213
Providence Oncology and Hematology Care Clinic - Westside ( Site 0059)
Portland, Oregon, 97225