Treatment-naive KRAS G12C-mutant advanced or metastatic nonsquamous non-small cell lung cancer
Conditions
Interventions
Experimental Arm
- MK-1084 oral until discontinuation criterion is met.
- MK-3475A subcutaneous (SC) Q6W cycle up to 18 cycles.
Comparator Arm
- MK-3475A SC Q6W cycle up to 18 cycles.
- Pemetrexed vi
Sponsors
Fujita Tomoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c - If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)
Exclusion criteria
Exclusion criteria: - Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements - Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea) - Has uncontrolled, significant cardiovascular disease or cerebrovascular disease - Has a gastrointestinal disorder affecting absorption - Is HIV positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease - Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC - Has known additional malignancy that is progressing or has required active treatment within the past 3 years - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Has active autoimmune disease that has required systemic treatment in the past 2 years - History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease - Has active infection requiring systemic therapy except those specified by protocol - Has history of stem cell/solid organ transplant - Has not adequately recovered from major surgery or has ongoing surgical complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS): PD-L1 positive participants | — |
Secondary
| Measure | Time frame |
|---|---|
| - PFS: all participants - Overall survival (OS) - Objective response (OR) - Duration of response (DOR) - safety and tolerability - Patient-reported Outcomes (PRO) | — |
Countries
Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Malaysia, Mexico, Peru, Poland, Romania, South Korea, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States, Vietnam
Contacts
Public ContactMSDJRCT inquiry mailbox
MSD K.K.
Outcome results
None listed