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
Merck Sharp & Dohme LLC
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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) that demonstrates the presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutations * Can provide an archival tumor tissue sample or newly obtained core, incisional, excisional biopsy of a tumor lesion not previously irradiated * Has recovered to ≤Grade 1 or baseline from any Adverse eve…
Interventions
- DrugMK-1084
Oral Administration
- BiologicalPembrolizumab
Intravenous administration
- BiologicalCetuximab
Intravenous administration
- DrugCarboplatin
Intravenous administration
- DrugPemetrexed
Intravenous administration
Locations (21)
- Clermont Oncology Center ( Site 0041)Clermont, Florida
- Sanford Health Roger Maris Cancer Center ( Site 0039)Fargo, North Dakota
- Sanford Cancer Center Oncology Clinic ( Site 0038)Sioux Falls, South Dakota
- West China Hospital, Sichuan University ( Site 0315)Chengdu, Sichuan
- Kuopion Yliopistollinen Sairaala ( Site 0261)Kuopio, Northern Savonia
- Turku University Hospital ( Site 0262)Turku, Southwest Finland