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Clinical Trials in the UK / NCT06345729
Recruiting Phase 3

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)

NCT06345729 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2024-05-24
Last updated
2026-09-08

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

CalderasibPlaceboPembrolizumab

Calderasib: Oral tablets

Placebo: Oral tablets

Pembrolizumab: IV infusion

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (225)

FacilityCityRegionStatus
CBCC Global Research, Inc. ( Site 0123) Bakersfield California Recruiting
Beverly Hills Cancer Center ( Site 0116) Beverly Hills California Recruiting
Stamford Hospital ( Site 0136) Stamford Connecticut Recruiting
Mount Sinai Cancer Center ( Site 0137) Miami Beach Florida Completed
Orchard Healthcare Research Inc. ( Site 0115) Skokie Illinois Recruiting
Truman Medical Center ( Site 0126) Kansas City Missouri Recruiting
Cox Medical Center North ( Site 0133) Springfield Missouri Recruiting
St. Vincent Frontier Cancer Center-Research ( Site 0105) Billings Montana Recruiting
Atlantic Health System Morristown Medical Center ( Site 0121) Morristown New Jersey Recruiting
New York Oncology Hematology, P.C. ( Site 0132) Albany New York Recruiting
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103) Cincinnati Ohio Recruiting
Kettering Health Main Campus-Kettering Health Cancer Center ( Site 0106) Kettering Ohio Completed
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0134) Lancaster Pennsylvania Recruiting
Oncology Consultants P.A. ( Site 0113) Houston Texas Recruiting
Circuit Clinical/SSM Health Dean Medical Group ( Site 0129) Madison Wisconsin Recruiting
AUSTRAL MEDICAL CENTER ( Site 0302) CABA Buenos Aires Completed
Centro Oncologico Korben ( Site 0304) CABA Buenos Aires Recruiting
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300) Mar del Plata Buenos Aires Recruiting
Fundacion Estudios Clinicos ( Site 0306) Rosario Santa Fe Province Recruiting
Sanatorio Parque ( Site 0301) Rosario Santa Fe Province Recruiting
Chris O'Brien Lifehouse ( Site 3000) Camperdown New South Wales Recruiting
Cancer Care Service Hervey Bay ( Site 3003) Urraween Queensland Recruiting
Frankston Hospital ( Site 3002) Frankston Victoria Recruiting
One Clinical Research ( Site 3001) Nedlands Western Australia Recruiting
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 2401) Graz Styria Recruiting
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 2400) Vienna Austria Recruiting
Hospital Mario Penna ( Site 0436) Belo Horizonte Minas Gerais Recruiting
Hospital de Câncer de Recife ( Site 0447) Recife Pernambuco Recruiting
Oncoclínica Oncologistas Associados ( Site 0441) Teresina Piauí Recruiting
Liga Norte Riograndense Contra o Câncer ( Site 0439) Natal Rio Grande do Norte Recruiting
Hospital de Caridade de Ijuí ( Site 0438) Ijuí Rio Grande do Sul Recruiting
Hospital de Clínicas de Passo Fundo ( Site 0442) Passo Fundo Rio Grande do Sul Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro Multidisciplinar de Pesquisa Clínica ( Site 0435) Porto Alegre Rio Grande do Sul Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0437) Barretos São Paulo Recruiting
Instituto Nacional de Câncer - INCA ( Site 0446) Rio de Janeiro Brazil Recruiting
Americas ( Site 0431) Rio de Janeiro Brazil Recruiting
MBAL Uni Hospital-Department of Medical Oncology ( Site 1000) Panagyurishte Pazardzhik Recruiting
Multiprofile Hospital for Active Treatment SerdikaМЕD EOOD-Second Department of Medical Oncology ( Site 1002) Sofia Sofia (stolitsa) Recruiting
MHAT - Heart and Brain ( Site 1006) Pleven Bulgaria Recruiting
Medical Center Futuremeds ( Site 1007) Plovdiv Bulgaria Recruiting

+ 185 more sites — see the full list on the official registry below.

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06345729 on ClinicalTrials.gov ↗ ← All trials in the UK