MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Recruiting · NCT07431827 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is a phase 3, randomized, double-blind study of adjuvant calderasib plus subcutaneous pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant placebo plus MK-3475a in participants with completely resected stage IIA-IIIB (N2), KRAS G12C-mutant non-small cell lung cancer following receipt of either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy. The primary goal of the study is to compare adjuvant calderasib plus MK-3475A to adjuvant placebo plus MK-3475A with respect to disease-free survival (DFS) as assessed by the investigator.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Has a histological/cytological diagnosis of non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology and meets one of the following criteria:
- Has newly diagnosed, treatment-naïve, resectable, clinical Stage IIA-IIIB (N2) NSCLC
- Has completely resected, pathological Stage IIA-IIIB (N2) NSCLC, including those previously treated outside the study with neoadjuvant platinum-doublet chemotherapy plus pembrolizumab or MK-3475A, or those who received adjuvant platinum-doublet chemotherapy.
- Tumor tissue shows the presence of Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation
- No more than 12 weeks have elapsed between either the surgery following neoadjuvant treatment or last dose of adjuvant platinum-based chemotherapy and the first dose of investigational adjuvant study intervention.
- Has no evidence of disease based on postsurgical radiological assessment as documented by contrast-enhanced chest/abdomen computed tomography (or magnetic resonance imaging) within 28 days before randomization
- Has an Eastern Cooperative Oncology Group performance status of 0 or 1 within 10 days before the first dose of the study intervention
- Human immunodeficiency virus-infected participants must have well controlled HIV on antiretroviral therapy
- Participants who are Hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion criteria
- Has a diagnosis of any 1 of the following tumor types/locations: small cell lung cancer or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or NSCLC involving the superior sulcus
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention
- Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, or malabsorption)
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has an active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has active infection requiring systemic therapy
- Has not adequately recovered from major surgery or has ongoing surgical complications
Where it is running
60 locations listed.
- Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1812) - Adana, Turkey (Türkiye)
- Adana Medical Park Seyhan Hastanesi ( Site 1827) - Adana, Turkey (Türkiye)
- Ankara Atatürk Sanatoryum Eğitim ve Araştırma Hastanesi ( Site 1825) - Ankara, Turkey (Türkiye)
- Hacettepe Universite Hastaneleri ( Site 1810) - Ankara, Turkey (Türkiye)
- Ankara Bilkent Şehir Hastanesi ( Site 1811) - Ankara, Turkey (Türkiye)
- Liv Hospital Ankara ( Site 1828) - Ankara, Turkey (Türkiye)
- Hospital Universitari Vall d'Hebron ( Site 1700) - Barcelona, Spain
- Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0306) - CABA, Argentina
- Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0309) - CABA, Argentina
- Queen Mary Hospital ( Site 3100) - Hong Kong, Hong Kong
- Tuen Mun Hospital ( Site 3102) - Hong Kong, Hong Kong
- Kartal Lütfi Kırdar Şehir Hastanesi ( Site 1826) - Istanbul, Turkey (Türkiye)
- Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1915) - Kyiv, Ukraine
- Shalimov Institute of Surgery and Transplantation ( Site 1907) - Kyiv, Ukraine
- Hospital Clinico San Carlos ( Site 1706) - Madrid, Spain
- Hospital Universitario la Paz ( Site 1710) - Madrid, Spain
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1707) - Madrid, Spain
- İnönü Üniversitesi Turgut Özal Tıp Merkezi ( Site 1815) - Malatya, Turkey (Türkiye)
- Mersin Sehir Eğitim ve Araştırma Hastanesi ( Site 1824) - Mersin, Turkey (Türkiye)
- H.R.U Malaga - Hospital General ( Site 1708) - Málaga, Spain
- Taipei Medical University Shuang Ho Hospital ( Site 3700) - New Taipei City, Taiwan
- Recep Tayyip Erdogan University Training and Research Hospital ( Site 1816) - Rize, Turkey (Türkiye)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1401) - Roma, Italy
- Sakarya Egitim ve Arastırma Hastanesi ( Site 1817) - Sakarya, Turkey (Türkiye)
- Severance Hospital Yonsei University Health System ( Site 3601) - Seoul, South Korea
- Asan Medical Center ( Site 3600) - Seoul, South Korea
- Hospital Universitario Virgen Macarena ( Site 1709) - Seville, Spain
- National Cheng Kung University Hospital ( Site 3706) - Tainan, Taiwan
- Mackay Memorial Hospital ( Site 3701) - Taipei, Taiwan
- Tri-Service General Hospital ( Site 3708) - Taipei, Taiwan
- Evangelismos General Hospital of Athens ( Site 1204) - Athens, Attica, Greece
- Errikos Dunant Hospital Center ( Site 1201) - Athens, Attica, Greece
- THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1206) - Athens, Attica, Greece
- Athens Medical Center ( Site 1202) - Athens, Attica, Greece
- Metaxa Cancer Hospital of Piraeus ( Site 1207) - Piraeus, Attica, Greece
- Peking University People's Hospital ( Site 2100) - Beijing, Beijing Municipality, China
- Beijing Cancer hospital ( Site 2106) - Beijing, Beijing Municipality, China
- Peking Union Medical College Hospital ( Site 2105) - Beijing, Beijing Municipality, China
- Instituto Alexander Fleming ( Site 0310) - Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
- Hospital Insular de Gran Canaria ( Site 1704) - Las Palmas de Gran Canaria, Canary Islands, Spain
- PRONUTRIR ( Site 0425) - Fortaleza, Ceará, Brazil
- G. Papanikolaou General Hospital ( Site 1203) - Thessaloniki, Central Macedonia, Greece
- COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 1904) - Cherkasy, Cherkasy Oblast, Ukraine
- Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 1909) - Chernivtsi, Chernivetska Oblast, Ukraine
- Chongqing University Three Gorges Hospital ( Site 2138) - Chongqing, Chongqing Municipality, China
- Medical Center "Mriya Med-Service" ( Site 1911) - Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine
- The First Affiliated Hospital Of Fujian Medical University ( Site 2123) - Fuzhou, Fujian, China
- Institut Català d'Oncologia (ICO) - Girona ( Site 1703) - Girona, Gerona, Spain
- Sun Yat-sen University Cancer Center ( Site 2134) - Guangzhou, Guangdong, China
- Guangxi Medical University Cancer Hospital ( Site 2115) - Nanning, Guangxi, China
- Fourth Hospital Of Hebei Medical University ( Site 2107) - Hshijiazhuang, Hebei, China
- Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 2139) - Wuhan, Hubei, China
- Xiangya Hospital Central South University ( Site 2136) - Changsha, Hunan, China
- Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regio ( Site 1900) - Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
- The First Affiliated Hospital of Nanchang University ( Site 2121) - Nanchang, Jiangxi, China
- Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 1916) - Kropyvnytskyi, Kirovohrad Oblast, Ukraine
- Ukrainian Center of Tomotherapy ( Site 1917) - Kropyvnytskyi, Kirovohrad Oblast, Ukraine
- National Cancer Center ( Site 3603) - Goyang-si, Kyonggi-do, South Korea
- The Catholic University of Korea St. Vincent s Hospital ( Site 3602) - Suwon, Kyonggi-do, South Korea
- Centre de Cancérologie du Grand Montpellier ( Site 1016) - Montpellier, Languedoc-Roussillon, France
Showing 60 of 86 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →