Actively Recruiting
MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-11
400
Participants Needed
24
Research Sites
710 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of non-small cell lung cancer with mostly nonsquamous histology
- Newly diagnosed, treatment-nafve, resectable clinical Stage IIA-IIIB (N2) NSCLC or completely resected pathological Stage IIA-IIIB (N2) NSCLC
- Tumor tissue shows KRAS G12C mutation
- No more than 12 weeks since surgery after neoadjuvant treatment or last adjuvant chemotherapy dose
- No evidence of disease based on recent postsurgical imaging within 28 days before randomization
- Eastern Cooperative Oncology Group performance status of 0 or 1 within 10 days before first treatment dose
- Well controlled HIV infection on antiretroviral therapy
- Hepatitis B surface antigen positive patients must have received antiviral therapy and have undetectable viral load
- History of hepatitis C infection eligible if viral load is undetectable
You will not qualify if you...
- Diagnosis of small cell lung cancer or tumors with small cell elements, neuroendocrine tumors with large cell components, sarcomatoid carcinoma, or NSCLC involving the superior sulcus
- HIV-infected participants with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Active inflammatory bowel disease requiring immunosuppressive medication or past history of inflammatory bowel disease
- Uncontrolled significant cardiovascular or cerebrovascular disease within 6 months prior to study
- Unable to swallow oral medication or gastrointestinal disorder affecting absorption
- Known progressing additional malignancy requiring treatment within past 3 years
- Active autoimmune disease requiring systemic treatment within past 2 years except replacement therapy
- History of pneumonitis/interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease
- Active infection needing systemic therapy
- Not fully recovered from major surgery or ongoing surgical complications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0309)
CABA, Argentina, C1431FWO
Actively Recruiting
2
Guangxi Medical University Cancer Hospital ( Site 2115)
Nanning, Guangxi, China, 530201
Actively Recruiting
3
Sichuan Cancer hospital ( Site 2101)
Chengdu, Sichuan, China, 610000
Actively Recruiting
4
The Third Peoples Hospital Of Chengdu ( Site 2141)
Chengdu, Sichuan, China, 610031
Actively Recruiting
5
Queen Mary Hospital ( Site 3100)
Hong Kong, Hong Kong
Actively Recruiting
6
National Cancer Center ( Site 3603)
Goyang-si, Kyonggi-do, South Korea, 10408
Actively Recruiting
7
Keimyung University Dongsan Hospital ( Site 3605)
Daegu, Taegu-Kwangyokshi, South Korea, 42601
Actively Recruiting
8
Severance Hospital Yonsei University Health System ( Site 3601)
Seoul, South Korea, 03722
Actively Recruiting
9
Asan Medical Center ( Site 3600)
Seoul, South Korea, 05505
Actively Recruiting
10
National Cheng Kung University Hospital ( Site 3706)
Tainan, Taiwan, 704
Actively Recruiting
11
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 1904)
Cherkasy, Cherkasy Oblast, Ukraine, 18009
Actively Recruiting
12
Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 1909)
Chernivtsi, Chernivetska Oblast, Ukraine, 58013
Actively Recruiting
13
Medical Center "Mriya Med-Service" ( Site 1911)
Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine, 50000
Actively Recruiting
14
Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regio ( Site 1900)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
Actively Recruiting
15
Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 1916)
Kropyvnytskyi, Kirovohrad Oblast, Ukraine, 25006
Actively Recruiting
16
Ukrainian Center of Tomotherapy ( Site 1917)
Kropyvnytskyi, Kirovohrad Oblast, Ukraine, 25011
Actively Recruiting
17
Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutical ( Site 1908)
Lviv, Lviv Oblast, Ukraine, 79031
Actively Recruiting
18
Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 1902)
Lviv, Lviv Oblast, Ukraine, 79059
Actively Recruiting
19
Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 1913)
Odesa, Odesa Oblast, Ukraine, 65025
Actively Recruiting
20
ME "Rivne Regional Antitumor Center" Rivne Regional Council ( Site 1912)
Rivne, Rivne Oblast, Ukraine, 33010
Actively Recruiting
21
Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 1903)
Vinnytsia, Vinnytsia Oblast, Ukraine, 21029
Actively Recruiting
22
Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council ( Site 1914)
Lutsk, Volyn Oblast, Ukraine, 43018
Actively Recruiting
23
Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1915)
Kyiv, Ukraine, 03057
Actively Recruiting
24
Shalimov Institute of Surgery and Transplantation ( Site 1907)
Kyiv, Ukraine, 03126
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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