Trials / Recruiting
RecruitingNCT07252739
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)
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MK-1084 | Oral Administration |
| BIOLOGICAL | Pembrolizumab | Intravenous administration |
| BIOLOGICAL | Cetuximab | Intravenous administration |
| DRUG | Carboplatin | Intravenous administration |
| DRUG | Pemetrexed | Intravenous administration |
Timeline
- Start date
- 2025-12-19
- Primary completion
- 2033-01-14
- Completion
- 2033-01-14
- First posted
- 2025-11-28
- Last updated
- 2026-04-17
Locations
18 sites across 6 countries: United States, Finland, Netherlands, South Korea, Turkey (Türkiye), Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07252739. Inclusion in this directory is not an endorsement.