Status:
RECRUITING
A Clinical Study of MK-1084 and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Researchers want to learn if the study medicines MK-1084 and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. MK-1084 is a targeted therapy ...
Eligibility Criteria
Inclusion
- The main inclusion criteria include but are not limited to the following:
- 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
- The main exclusion criteria include but are not limited to the following:
- 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
Key Trial Info
Start Date :
October 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 6 2032
Estimated Enrollment :
675 Patients enrolled
Trial Details
Trial ID
NCT07190248
Start Date
October 8 2025
End Date
August 6 2032
Last Update
January 9 2026
Active Locations (31)
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1
Central Alabama Research ( Site 0108)
Birmingham, Alabama, United States, 35209
2
Stamford Hospital ( Site 0126)
Stamford, Connecticut, United States, 06902
3
Mount Sinai Cancer Center ( Site 0137)
Miami Beach, Florida, United States, 33140
4
New England Cancer Specialists ( Site 0139)
Westbrook, Maine, United States, 04092