A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
Recruiting now Phase 3 NCT07190248
Run by Merck Sharp & Dohme LLC · for 18 and older · All sexes
What this study is about
Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation. The goal of this study is to learn if people who receive calderasib with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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)
🚫 You may not be able to join if…
- 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
Where this trial is running
- Central Alabama Research ( Site 0108), Birmingham, Alabama, United States
- Stamford Hospital ( Site 0126), Stamford, Connecticut, United States
- Mount Sinai Cancer Center ( Site 0137), Miami Beach, Florida, United States
- Indiana University Health Arnett Cancer Center ( Site 0116), Lafayette, Indiana, United States
- New England Cancer Specialists ( Site 0139), Westbrook, Maine, United States
- New York Oncology Hematology, P.C. ( Site 0119), Albany, New York, United States
- St. Charles Health System, Inc ( Site 0146), Bend, Oregon, United States
- Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111), Lancaster, Pennsylvania, United States
- Blue Ridge Cancer Care ( Site 0144), Roanoke, Virginia, United States
- Instituto Alexander Fleming ( Site 0311), Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
- Instituto de Investigaciones Clinicas Mar del Plata ( Site 0300), Mar del Plata, Buenos Aires, Argentina
- Hospital Italiano de Cordoba ( Site 0308), Córdoba, Argentina
+ 174 more sites.
Who to contact
Toll Free Number · 1-888-577-8839 · Trialsites@msd.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07190248.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.