Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07252739 | KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J) | PHASE2 | RECRUITING | 130 | — | — | Dec 19, 2025 | Jan 14, 2033 | May 26, 2026 | 26 | United States, Chile +8 |
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Participants receive 400 mg of Pembrolizumab every 6 weeks, Carbo platin every 3 weeks and 500 mg/m\^2 of Pemetrexed every 3 weeks. |
| Arm 2 | EXPERIMENTAL | Participants receive 400 mg of Pembrolizumab every 6 weeks, and MK-1084 dose regimen |
| Arm 3 | EXPERIMENTAL | Participants receive 400 mg of Pembrolizumab every 6 weeks, 500 mg/m\^2 Cetuximab every 2 weeks, and MK-1084 dose regimen |
| Name | Type | Description |
|---|---|---|
| MK-1084 | DRUG | Oral Administration |
| Pembrolizumab | BIOLOGICAL | Intravenous administration |
| Cetuximab | BIOLOGICAL | Intravenous administration |
| Carboplatin | DRUG | Intravenous administration |
| Pemetrexed | DRUG | Intravenous administration |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically or cytologically confirmed diagnosis of advanced or metastatic nonsquamous Non-Small Cell Lung Cancer (NSCLC) * Has tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA) tha...