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

Conditions studied: Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT07190248

Run by

Merck Sharp & Dohme LLC

People needed

675

Starts

2025-10-08

Expected to finish

2032-08-06

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Central Alabama Research ( Site 0108) — Birmingham, Alabama, United States (enrolling)
• Stamford Hospital ( Site 0126) — Stamford, Connecticut, United States (enrolling)
• University of Connecticut Health Center ( Site 0130) — Farmington, Connecticut, United States (enrolling)
• Indiana University Health Arnett Cancer Center ( Site 0116) — Lafayette, Indiana, United States (enrolling)
• New England Cancer Specialists ( Site 0139) — Westbrook, Maine, United States (enrolling)
• New York Oncology Hematology, P.C. ( Site 0119) — Albany, New York, United States (enrolling)
• St. Charles Health System, Inc ( Site 0146) — Bend, Oregon, United States (enrolling)
• Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111) — Lancaster, Pennsylvania, United States (enrolling)
• Blue Ridge Cancer Care ( Site 0144) — Roanoke, Virginia, United States (enrolling)
• Instituto Alexander Fleming ( Site 0311) — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (enrolling)
• Instituto de Investigaciones Clinicas Mar del Plata ( Site 0300) — Mar del Plata, Buenos Aires, Argentina (enrolling)
• Hospital Italiano de Cordoba ( Site 0308) — Córdoba, Argentina (enrolling)
• CEMAIC ( Site 0309) — Córdoba, Argentina (enrolling)
• Genesis Care- Campbelltown ( Site 2907) — Campbelltown, New South Wales, Australia (enrolling)
• Northern Beaches Hospital ( Site 2905) — Frenchs Forest, New South Wales, Australia (enrolling)
• The Prince Charles Hospital ( Site 2903) — Brisbane, Queensland, Australia (enrolling)
• Mater Hospital Brisbane ( Site 2906) — South Brisbane, Queensland, Australia (enrolling)
• Peninsula & South Eastern Haematology and Oncology Group ( Site 2908) — Frankston, Victoria, Australia (enrolling)
• Klinikum Klagenfurt am Wörthersee ( Site 1002) — Klagenfurt, Carinthia, Austria (enrolling)
• Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1005) — Graz, Styria, Austria (enrolling)
• Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1001) — Vienna, Austria (enrolling)
• Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3903) — Genk, Limburg, Belgium (enrolling)
• VITAZ ( Site 3902) — Sint-Niklaas, Oost-Vlaanderen, Belgium (enrolling)
• CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0412) — Fortaleza, Ceará, Brazil (enrolling)
• Hospital Santa Rita de Cassia ( Site 0403) — Vitória, Espírito Santo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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