A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Non-small Cell Lung Cancer
In brief
This is a study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two primary study hypotheses: Hypothesis 1: Combination of calderasib and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Hypothesis 2: Combination of calderasib plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS).
Key facts
- Study ID
- NCT06345729
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 600
- Starts
- 2024-05-24
- Expected to finish
- 2031-02-18
- Last updated by the study team
- 2026-06-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
- Has newly diagnosed Stage IIIB/IIIC NSCLC, not eligible for curative resection or curative chemotherapy/radiation as determined by a multidisciplinary tumor board and/or by radiation oncologist, surgeon, and medical oncologist or Stage IV (M1a, M1b, or M1c) by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8
- Provides an archival tumor tissue sample (≤5 years) or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, PD-L1 status, and biomarker research
- If have had adverse events (AEs) due to previous anticancer therapies, must have recovered to < Grade 1 or baseline
- If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART)
- If Hepatitis B surface antigen (HBsAg) positive, have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable
You may not qualify if…
- Has diagnosis of small cell lung cancer. For mixed tumors, if small cell elements are present, the participant is ineligible
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
- Has known history of, or active, neurologic paraneoplastic syndrome
- Has an active infection requiring systemic therapy, with exceptions
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has one or more of the following ophthalmological findings/conditions: intraocular pressure >21 mmHg and/or any diagnosis of glaucoma, diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion, diagnosis of retinal degenerative disease
- Has received prior systemic anticancer therapy for their locally advanced or metastatic NSCLC
- Has received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention
- Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not required corticosteroids, and not have had radiation pneumonitis
- Has known active central nervous system metastases and/or carcinomatous meningitis
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Is HIV-infected and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has history of allogenic tissue/solid organ transplant
- Has not fully recovered from any effects of major surgical procedure
Where it is running
- Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 2400) — Vienna, Austria (enrolling)
- Hospital Mario Penna ( Site 0436) — Belo Horizonte, Minas Gerais, Brazil (enrolling)
- CBCC Global Research, Inc. ( Site 0123) — Bakersfield, California, United States (enrolling)
- Orchard Healthcare Research Inc. ( Site 0115) — Skokie, Illinois, United States (enrolling)
- Stamford Hospital ( Site 0136) — Stamford, Connecticut, United States (enrolling)
- Cox Medical Center North ( Site 0133) — Springfield, Missouri, United States (enrolling)
- Beverly Hills Cancer Center ( Site 0116) — Beverly Hills, California, United States (enrolling)
- Atlantic Health System Morristown Medical Center ( Site 0121) — Morristown, New Jersey, United States (enrolling)
- New York Oncology Hematology, P.C. ( Site 0132) — Albany, New York, United States (enrolling)
- University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103) — Cincinnati, Ohio, United States (enrolling)
- Truman Medical Center ( Site 0126) — Kansas City, Missouri, United States (enrolling)
- Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0134) — Lancaster, Pennsylvania, United States (enrolling)
- Oncology Consultants P.A. ( Site 0113) — Houston, Texas, United States (enrolling)
- Circuit Clinical/SSM Health Dean Medical Group ( Site 0129) — Madison, Wisconsin, United States (enrolling)
- St. Vincent Frontier Cancer Center-Research ( Site 0105) — Billings, Montana, United States (enrolling)
- Centro Oncologico Korben ( Site 0304) — CABA, Buenos Aires, Argentina (enrolling)
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300) — Mar del Plata, Buenos Aires, Argentina (enrolling)
- Fundacion Estudios Clinicos ( Site 0306) — Rosario, Santa Fe Province, Argentina (enrolling)
- Sanatorio Parque ( Site 0301) — Rosario, Santa Fe Province, Argentina (enrolling)
- Chris O'Brien Lifehouse ( Site 3000) — Camperdown, New South Wales, Australia (enrolling)
- Cancer Care Service Hervey Bay ( Site 3003) — Urraween, Queensland, Australia (enrolling)
- Frankston Hospital ( Site 3002) — Frankston, Victoria, Australia (enrolling)
- One Clinical Research ( Site 3001) — Nedlands, Western Australia, Australia (enrolling)
- Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 2401) — Graz, Styria, Austria (enrolling)
- Hospital de Câncer de Recife ( Site 0447) — Recife, Pernambuco, Brazil (enrolling)
Full record on ClinicalTrials.gov
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